Trial Outcomes & Findings for A Study to Continue ASP015K Treatment to Rheumatoid Arthritis Patients Who Completed Phase IIb Study or Phase III Study of ASP015K (NCT NCT01638013)
NCT ID: NCT01638013
Last Updated: 2024-10-28
Results Overview
AE was defined as any untoward medical occurrence in a participant administered a study drug that did not necessarily have a causal relationship to this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
843 participants
Primary outcome timeframe
Baseline up to end of study (EOS) (up to week 376)
Results posted on
2024-10-28
Participant Flow
Participants who completed 015K-CL-RAJ1 (NCT01649999), 015K-CL-RAJ3 (NCT02308163), 015K-CL-RAJ4 (NCT02305849) and met eligible criteria were enrolled in this study. Participants in the etanercept group in study 015K-CL-RAJ3 (NCT01649999) were not included in this study.
For participants who were on 50mg at the time of peficitinib approval, dose was increased to 100mg. Participants whose dose increment was not possible were discontinued.
Participant milestones
| Measure |
Participants Who Completed 015K-CL-RAJ1
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Overall Study
STARTED
|
201
|
225
|
417
|
|
Overall Study
COMPLETED
|
70
|
147
|
296
|
|
Overall Study
NOT COMPLETED
|
131
|
78
|
121
|
Reasons for withdrawal
| Measure |
Participants Who Completed 015K-CL-RAJ1
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50 milligrams (mg) peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
36
|
29
|
48
|
|
Overall Study
Lack of Efficacy
|
39
|
11
|
14
|
|
Overall Study
Protocol Violation
|
10
|
7
|
11
|
|
Overall Study
Met discontinuation criteria
|
4
|
0
|
7
|
|
Overall Study
Subject Lost to Follow up
|
1
|
0
|
1
|
|
Overall Study
Miscellaneous
|
25
|
19
|
23
|
|
Overall Study
Withdrawal of Consent
|
16
|
12
|
16
|
|
Overall Study
Not met inclusion or exclusion criteria
|
0
|
0
|
1
|
Baseline Characteristics
FAS population with available data.
Baseline characteristics by cohort
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Total
n=837 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.7 Years
STANDARD_DEVIATION 11.3 • n=201 Participants
|
55.2 Years
STANDARD_DEVIATION 12.8 • n=224 Participants
|
57.2 Years
STANDARD_DEVIATION 11.5 • n=412 Participants
|
55.6 Years
STANDARD_DEVIATION 11.9 • n=837 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=201 Participants
|
163 Participants
n=224 Participants
|
293 Participants
n=412 Participants
|
614 Participants
n=837 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=201 Participants
|
61 Participants
n=224 Participants
|
119 Participants
n=412 Participants
|
223 Participants
n=837 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=201 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=837 Participants
|
|
Race (NIH/OMB)
Asian
|
201 Participants
n=201 Participants
|
224 Participants
n=224 Participants
|
412 Participants
n=412 Participants
|
837 Participants
n=837 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=201 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=837 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=201 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=837 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=201 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=837 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=201 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=837 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=201 Participants
|
0 Participants
n=224 Participants
|
0 Participants
n=412 Participants
|
0 Participants
n=837 Participants
|
|
C-Reactive Protein (CRP)
|
2.214 Milligram per deciliter
STANDARD_DEVIATION 2.379 • n=201 Participants • FAS population with available data.
|
2.167 Milligram per deciliter
STANDARD_DEVIATION 2.000 • n=224 Participants • FAS population with available data.
|
2.476 Milligram per deciliter
STANDARD_DEVIATION 2.077 • n=412 Participants • FAS population with available data.
|
2.331 Milligram per deciliter
STANDARD_DEVIATION 2.136 • n=837 Participants • FAS population with available data.
|
|
Erythrocyte Sedimentation Rate (ESR)
|
44.8 Millimeter per hour (mm/h)
STANDARD_DEVIATION 22.2 • n=201 Participants • FAS population with available data.
|
47.0 Millimeter per hour (mm/h)
STANDARD_DEVIATION 25.9 • n=223 Participants • FAS population with available data.
|
50.7 Millimeter per hour (mm/h)
STANDARD_DEVIATION 26.2 • n=411 Participants • FAS population with available data.
|
48.3 Millimeter per hour (mm/h)
STANDARD_DEVIATION 25.3 • n=835 Participants • FAS population with available data.
|
|
Health Assessment Questionnaire - Disability Index (HAQ-DI)
|
0.89 Units on a scale
STANDARD_DEVIATION 0.63 • n=201 Participants • FAS population with available data.
|
0.93 Units on a scale
STANDARD_DEVIATION 0.67 • n=223 Participants • FAS population with available data.
|
1.00 Units on a scale
STANDARD_DEVIATION 0.65 • n=412 Participants • FAS population with available data.
|
0.96 Units on a scale
STANDARD_DEVIATION 0.65 • n=836 Participants • FAS population with available data.
|
|
Physician's Global Assessment of Arthritis
|
55.68 Units on a scale
STANDARD_DEVIATION 20.66 • n=201 Participants • FAS population with available data.
|
58.52 Units on a scale
STANDARD_DEVIATION 19.55 • n=223 Participants • FAS population with available data.
|
59.47 Units on a scale
STANDARD_DEVIATION 19.70 • n=412 Participants • FAS population with available data.
|
58.3 Units on a scale
STANDARD_DEVIATION 19.93 • n=836 Participants • FAS population with available data.
|
|
Subject's Global Assessment of Arthritis
|
56.15 Units on a scale
STANDARD_DEVIATION 25.10 • n=201 Participants • FAS population with available data.
|
57.40 Units on a scale
STANDARD_DEVIATION 25.24 • n=223 Participants • FAS population with available data.
|
54.79 Units on a scale
STANDARD_DEVIATION 24.94 • n=412 Participants • FAS population with available data.
|
55.81 Units on a scale
STANDARD_DEVIATION 25.06 • n=836 Participants • FAS population with available data.
|
|
Subject's Global Assessment of Arthritis Pain
|
56.12 Units on a scale
STANDARD_DEVIATION 24.71 • n=201 Participants • FAS population with available data.
|
56.79 Units on a scale
STANDARD_DEVIATION 25.44 • n=223 Participants • FAS population with available data.
|
54.19 Units on a scale
STANDARD_DEVIATION 25.63 • n=412 Participants • FAS population with available data.
|
55.35 Units on a scale
STANDARD_DEVIATION 25.36 • n=836 Participants • FAS population with available data.
|
|
Swollen Joint Count (66 Joints)
|
12.0 Swollen joint count
STANDARD_DEVIATION 6.1 • n=201 Participants • FAS population with available data.
|
12.4 Swollen joint count
STANDARD_DEVIATION 6.7 • n=223 Participants • FAS population with available data.
|
13.1 Swollen joint count
STANDARD_DEVIATION 6.9 • n=412 Participants • FAS population with available data.
|
12.7 Swollen joint count
STANDARD_DEVIATION 6.7 • n=836 Participants • FAS population with available data.
|
|
Tender Joint Count (68 Joints)
|
15.1 Tender joint count
STANDARD_DEVIATION 9.3 • n=201 Participants • FAS population with available data.
|
15.0 Tender joint count
STANDARD_DEVIATION 9.8 • n=223 Participants • FAS population with available data.
|
14.9 Tender joint count
STANDARD_DEVIATION 8.9 • n=412 Participants • FAS population with available data.
|
15 Tender joint count
STANDARD_DEVIATION 9.2 • n=836 Participants • FAS population with available data.
|
PRIMARY outcome
Timeframe: Baseline up to end of study (EOS) (up to week 376)Population: Safety Population: All participants who received at least 1 dose of the study drug.
AE was defined as any untoward medical occurrence in a participant administered a study drug that did not necessarily have a causal relationship to this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a study drug, whether or not related to the study drug.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=225 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=417 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
Serious AE (SAE)
|
59 Participants
|
56 Participants
|
84 Participants
|
|
Number of Participants With Adverse Events
AE leading to dose reduction of study drug
|
4 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
Adverse Events (AE)
|
193 Participants
|
208 Participants
|
395 Participants
|
|
Number of Participants With Adverse Events
Drug related AE (DAE)
|
175 Participants
|
160 Participants
|
321 Participants
|
|
Number of Participants With Adverse Events
Deaths
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Drug Related serious AE (DSAE)
|
22 Participants
|
37 Participants
|
54 Participants
|
|
Number of Participants With Adverse Events
Grade 3 or higher in severity AE
|
75 Participants
|
73 Participants
|
118 Participants
|
|
Number of Participants With Adverse Events
AE leading to permanent discontinuation of study
|
50 Participants
|
34 Participants
|
56 Participants
|
|
Number of Participants With Adverse Events
DAE leading to permanent discontinuation of drug
|
30 Participants
|
18 Participants
|
44 Participants
|
|
Number of Participants With Adverse Events
SAE leading to permanent discontinuation of drug
|
23 Participants
|
20 Participants
|
32 Participants
|
|
Number of Participants With Adverse Events
DSAE leading to permanent discontinuation of drug
|
11 Participants
|
12 Participants
|
27 Participants
|
|
Number of Participants With Adverse Events
DAE leading to dose reduction of study drug
|
4 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
AE leading to temporary discontinuation of drug
|
81 Participants
|
86 Participants
|
191 Participants
|
|
Number of Participants With Adverse Events
DAE leading to temporary discontinuation of drug
|
67 Participants
|
76 Participants
|
158 Participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. EOT was defined as end of treatment i.e, either early termination (ET) or week 372. EOS was defined as end of study i.e. 28days from EOT.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 0
|
29.5 percentage of participants
|
82.5 percentage of participants
|
86.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 2
|
37.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 4
|
42.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 8
|
47.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 12
|
55.1 percentage of participants
|
81.2 percentage of participants
|
85.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 16
|
59.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 20
|
63.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 24
|
63.6 percentage of participants
|
85.5 percentage of participants
|
89.1 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 36
|
68.0 percentage of participants
|
83.9 percentage of participants
|
91.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 40
|
70.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 44
|
73.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 48
|
76.1 percentage of participants
|
83.7 percentage of participants
|
90.2 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 60
|
73.2 percentage of participants
|
81.7 percentage of participants
|
89.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 72
|
77.3 percentage of participants
|
86.3 percentage of participants
|
90.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 84
|
76.4 percentage of participants
|
80.6 percentage of participants
|
89.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 96
|
78.1 percentage of participants
|
85.0 percentage of participants
|
90.6 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 108
|
77.4 percentage of participants
|
79.3 percentage of participants
|
91.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 120
|
78.5 percentage of participants
|
84.5 percentage of participants
|
91.1 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 132
|
79.4 percentage of participants
|
81.0 percentage of participants
|
91.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
EOT
|
64.7 percentage of participants
|
74.6 percentage of participants
|
87.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 144
|
83.3 percentage of participants
|
85.6 percentage of participants
|
91.9 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 28
|
65.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 32
|
62.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 156
|
79.0 percentage of participants
|
90.0 percentage of participants
|
93.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 168
|
77.6 percentage of participants
|
75.7 percentage of participants
|
93.4 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 180
|
79.8 percentage of participants
|
81.0 percentage of participants
|
93.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 192
|
82.9 percentage of participants
|
62.5 percentage of participants
|
95.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 204
|
83.2 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 216
|
80.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
EOS
|
52.5 percentage of participants
|
69.2 percentage of participants
|
68.5 percentage of participants
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 228
|
80.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 240
|
78.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 252
|
78.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 264
|
75.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 276
|
81.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 288
|
76.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 300
|
76.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 312
|
81.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 324
|
82.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 336
|
75.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 348
|
70.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 360
|
87.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 28
|
40.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 144
|
63.3 percentage of participants
|
68.0 percentage of participants
|
77.2 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 180
|
61.4 percentage of participants
|
71.4 percentage of participants
|
76.1 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 228
|
64.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 240
|
61.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 312
|
59.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 336
|
60.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 360
|
68.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
EOT
|
45.8 percentage of participants
|
59.8 percentage of participants
|
73.8 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 108
|
56.4 percentage of participants
|
64.6 percentage of participants
|
77.9 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 0
|
8.5 percentage of participants
|
62.8 percentage of participants
|
67.5 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 2
|
9.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 4
|
14.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 8
|
23.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 12
|
28.3 percentage of participants
|
60.1 percentage of participants
|
67.4 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 16
|
30.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 20
|
34.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 120
|
56.2 percentage of participants
|
67.6 percentage of participants
|
76.1 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 132
|
59.5 percentage of participants
|
72.4 percentage of participants
|
78.3 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 24
|
36.9 percentage of participants
|
63.8 percentage of participants
|
73.1 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 32
|
38.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 36
|
41.3 percentage of participants
|
65.9 percentage of participants
|
74.5 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 40
|
42.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 44
|
46.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 48
|
48.5 percentage of participants
|
67.3 percentage of participants
|
75.7 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 60
|
49.0 percentage of participants
|
64.4 percentage of participants
|
77.5 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 72
|
55.3 percentage of participants
|
66.1 percentage of participants
|
79.1 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 84
|
52.1 percentage of participants
|
63.9 percentage of participants
|
75.1 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 156
|
62.2 percentage of participants
|
75.7 percentage of participants
|
74.5 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 168
|
64.7 percentage of participants
|
70.3 percentage of participants
|
78.9 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 192
|
63.1 percentage of participants
|
62.5 percentage of participants
|
77.3 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 204
|
68.2 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 216
|
61.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 252
|
62.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 264
|
63.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 276
|
65.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 288
|
61.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 300
|
63.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 324
|
62.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 348
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
EOS
|
31.7 percentage of participants
|
41.5 percentage of participants
|
47.2 percentage of participants
|
|
Percentage of Participants With an ACR50-CRP Response Through Week 372
Week 96
|
54.7 percentage of participants
|
64.2 percentage of participants
|
77.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) C-reactive protein at each visit.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 12
|
12.1 percentage of participants
|
40.4 percentage of participants
|
46.1 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 40
|
22.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 44
|
23.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 48
|
25.2 percentage of participants
|
41.3 percentage of participants
|
54.8 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 60
|
24.2 percentage of participants
|
45.5 percentage of participants
|
53.7 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 72
|
26.7 percentage of participants
|
42.6 percentage of participants
|
56.7 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 84
|
29.3 percentage of participants
|
44.4 percentage of participants
|
55.3 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 96
|
29.9 percentage of participants
|
43.9 percentage of participants
|
56.0 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 228
|
43.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 276
|
44.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 0
|
3.5 percentage of participants
|
42.2 percentage of participants
|
45.9 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 2
|
4.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 4
|
6.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 8
|
9.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 16
|
12.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 20
|
13.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 24
|
17.1 percentage of participants
|
40.6 percentage of participants
|
51.5 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 28
|
18.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 32
|
17.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 36
|
22.7 percentage of participants
|
42.4 percentage of participants
|
50.9 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 360
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 372
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
EOT
|
29.9 percentage of participants
|
39.7 percentage of participants
|
53.4 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
EOS
|
19.8 percentage of participants
|
24.6 percentage of participants
|
33.7 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 108
|
35.3 percentage of participants
|
47.6 percentage of participants
|
57.3 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 120
|
35.4 percentage of participants
|
48.6 percentage of participants
|
52.6 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 132
|
36.5 percentage of participants
|
48.3 percentage of participants
|
55.4 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 144
|
36.7 percentage of participants
|
48.5 percentage of participants
|
52.9 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 156
|
39.5 percentage of participants
|
48.6 percentage of participants
|
48.1 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 168
|
39.7 percentage of participants
|
48.6 percentage of participants
|
52.6 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 180
|
42.1 percentage of participants
|
47.6 percentage of participants
|
58.7 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 192
|
44.1 percentage of participants
|
50.0 percentage of participants
|
59.1 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 204
|
46.7 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 216
|
41.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 240
|
44.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 252
|
46.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 264
|
43.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 288
|
41.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 300
|
40.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 312
|
46.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 324
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 336
|
41.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-CRP Response Through Week 372
Week 348
|
27.5 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
ACR20 response: ≥20% improvement in tender or swollen joint count; and ≥ 20% improvement in at least 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a health assessment questionnaire, and 5) ESR at each visit.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 252
|
77.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 264
|
74.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 276
|
79.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 288
|
73.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 300
|
75.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 312
|
78.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 324
|
79.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 336
|
75.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 348
|
65.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 360
|
81.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
EOT
|
64.2 percentage of participants
|
74.6 percentage of participants
|
87.4 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
EOS
|
53.5 percentage of participants
|
67.7 percentage of participants
|
68.5 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 0
|
28.5 percentage of participants
|
80.3 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 84
|
74.3 percentage of participants
|
80.0 percentage of participants
|
89.6 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 96
|
77.4 percentage of participants
|
83.2 percentage of participants
|
90.2 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 2
|
37.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 4
|
42.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 8
|
45.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 12
|
52.0 percentage of participants
|
80.7 percentage of participants
|
85.3 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 16
|
61.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 20
|
63.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 24
|
63.6 percentage of participants
|
84.5 percentage of participants
|
88.8 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 28
|
65.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 32
|
63.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 36
|
66.3 percentage of participants
|
82.4 percentage of participants
|
91.1 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 40
|
67.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 44
|
70.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 48
|
74.2 percentage of participants
|
82.7 percentage of participants
|
88.8 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 60
|
73.2 percentage of participants
|
81.7 percentage of participants
|
88.5 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 108
|
75.2 percentage of participants
|
79.3 percentage of participants
|
90.6 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 72
|
76.7 percentage of participants
|
84.2 percentage of participants
|
90.3 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 120
|
76.9 percentage of participants
|
83.1 percentage of participants
|
90.6 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 132
|
77.8 percentage of participants
|
80.2 percentage of participants
|
90.9 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 144
|
81.7 percentage of participants
|
84.5 percentage of participants
|
91.9 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 156
|
77.3 percentage of participants
|
90.0 percentage of participants
|
91.5 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 168
|
77.6 percentage of participants
|
73.0 percentage of participants
|
90.8 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 180
|
80.7 percentage of participants
|
81.0 percentage of participants
|
93.5 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 192
|
80.2 percentage of participants
|
62.5 percentage of participants
|
95.5 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 204
|
82.2 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 216
|
78.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 228
|
80.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR20 Erythrocyte Sedimentation Rate (ESR) Response Through Week 372
Week 240
|
76.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
ACR50 response: ≥50% improvement in tender or swollen joint counts and 50% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 12
|
24.2 percentage of Participants
|
58.3 percentage of Participants
|
66.4 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 32
|
34.6 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 36
|
38.4 percentage of Participants
|
64.4 percentage of Participants
|
72.2 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 48
|
45.4 percentage of Participants
|
62.2 percentage of Participants
|
74.1 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 0
|
8.0 percentage of Participants
|
58.3 percentage of Participants
|
65.3 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 2
|
9.0 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 4
|
13.1 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 8
|
21.6 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 16
|
29.1 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 20
|
31.1 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 24
|
33.2 percentage of Participants
|
60.9 percentage of Participants
|
71.1 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 28
|
38.6 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 40
|
41.1 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 44
|
44.8 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 60
|
45.9 percentage of Participants
|
62.8 percentage of Participants
|
74.7 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 72
|
51.3 percentage of Participants
|
65.0 percentage of Participants
|
76.8 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 84
|
49.3 percentage of Participants
|
61.7 percentage of Participants
|
73.7 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 96
|
54.7 percentage of Participants
|
61.8 percentage of Participants
|
74.6 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 108
|
54.9 percentage of Participants
|
63.4 percentage of Participants
|
75.3 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 120
|
55.4 percentage of Participants
|
64.9 percentage of Participants
|
75.6 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 132
|
58.7 percentage of Participants
|
71.6 percentage of Participants
|
75.4 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 144
|
60.8 percentage of Participants
|
66.0 percentage of Participants
|
77.2 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 156
|
61.3 percentage of Participants
|
70.0 percentage of Participants
|
72.6 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 168
|
63.8 percentage of Participants
|
67.6 percentage of Participants
|
76.3 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 180
|
57.9 percentage of Participants
|
61.9 percentage of Participants
|
73.9 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 192
|
60.4 percentage of Participants
|
62.5 percentage of Participants
|
72.7 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 204
|
63.6 percentage of Participants
|
100.0 percentage of Participants
|
100.0 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 216
|
58.7 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 228
|
63.3 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 240
|
56.8 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 252
|
57.8 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 264
|
55.6 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 276
|
59.3 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 288
|
58.3 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 300
|
60.5 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 312
|
55.7 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 324
|
54.7 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 336
|
56.6 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 348
|
45.0 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 360
|
62.5 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
Week 372
|
100.0 percentage of Participants
|
—
|
—
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
EOT
|
45.8 percentage of Participants
|
58.9 percentage of Participants
|
72.3 percentage of Participants
|
|
Percentage of Participants With an ACR50-ESR Response Through Week 372
EOS
|
28.7 percentage of Participants
|
38.5 percentage of Participants
|
46.1 percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
ACR70 response: ≥ 70% improvement in tender or swollen joint counts and 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional ability via a health assessment questionnaire-Disability Index, and 5) ESR at each visit.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 168
|
37.1 percentage of participants
|
45.9 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
EOS
|
17.8 percentage of participants
|
20.0 percentage of participants
|
32.6 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 0
|
2.5 percentage of participants
|
36.8 percentage of participants
|
41.3 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 2
|
4.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 4
|
5.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 8
|
7.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 12
|
10.1 percentage of participants
|
36.2 percentage of participants
|
42.9 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 16
|
9.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 20
|
11.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 24
|
12.8 percentage of participants
|
36.2 percentage of participants
|
47.0 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 28
|
16.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 32
|
17.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 36
|
22.1 percentage of participants
|
38.0 percentage of participants
|
44.6 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 40
|
20.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 44
|
19.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 48
|
22.1 percentage of participants
|
38.3 percentage of participants
|
50.1 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 60
|
21.0 percentage of participants
|
41.4 percentage of participants
|
50.8 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 72
|
25.3 percentage of participants
|
38.8 percentage of participants
|
51.9 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 84
|
27.1 percentage of participants
|
40.0 percentage of participants
|
51.5 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 96
|
28.5 percentage of participants
|
39.9 percentage of participants
|
52.8 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 108
|
34.6 percentage of participants
|
42.7 percentage of participants
|
52.1 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 120
|
32.3 percentage of participants
|
43.9 percentage of participants
|
49.3 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 132
|
34.1 percentage of participants
|
39.7 percentage of participants
|
53.1 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 144
|
34.2 percentage of participants
|
42.3 percentage of participants
|
49.3 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 156
|
37.8 percentage of participants
|
47.1 percentage of participants
|
46.2 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 180
|
36.8 percentage of participants
|
47.6 percentage of participants
|
56.5 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 192
|
42.3 percentage of participants
|
50.0 percentage of participants
|
59.1 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 204
|
44.9 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 216
|
42.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 228
|
43.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 240
|
41.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 252
|
42.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 264
|
40.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 276
|
38.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 288
|
39.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 300
|
35.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 312
|
43.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 324
|
43.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 336
|
35.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 348
|
27.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 360
|
37.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
Week 372
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With an ACR70-ESR Response Through Week 372
EOT
|
28.4 percentage of participants
|
38.4 percentage of participants
|
50.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 0
|
-0.71 units on a scale
Standard Deviation 1.10
|
-2.67 units on a scale
Standard Deviation 1.32
|
-2.79 units on a scale
Standard Deviation 1.23
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 2
|
-1.04 units on a scale
Standard Deviation 1.10
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 4
|
-1.09 units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 8
|
-1.41 units on a scale
Standard Deviation 1.13
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 12
|
-1.61 units on a scale
Standard Deviation 1.17
|
-2.64 units on a scale
Standard Deviation 1.34
|
-2.82 units on a scale
Standard Deviation 1.26
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 16
|
-1.76 units on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 20
|
-1.85 units on a scale
Standard Deviation 1.19
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 216
|
-2.70 units on a scale
Standard Deviation 1.38
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 228
|
-2.75 units on a scale
Standard Deviation 1.35
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 240
|
-2.77 units on a scale
Standard Deviation 1.36
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 252
|
-2.75 units on a scale
Standard Deviation 1.42
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 264
|
-2.75 units on a scale
Standard Deviation 1.41
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 276
|
-2.86 units on a scale
Standard Deviation 1.29
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 288
|
-2.81 units on a scale
Standard Deviation 1.39
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 300
|
-2.81 units on a scale
Standard Deviation 1.42
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 312
|
-2.79 units on a scale
Standard Deviation 1.36
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 324
|
-2.89 units on a scale
Standard Deviation 1.29
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 336
|
-2.65 units on a scale
Standard Deviation 1.23
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 348
|
-2.53 units on a scale
Standard Deviation 1.25
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 360
|
-3.28 units on a scale
Standard Deviation 1.06
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 372
|
-4.63 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
EOS
|
-2.14 units on a scale
Standard Deviation 1.57
|
-2.67 units on a scale
Standard Deviation 1.50
|
-3.05 units on a scale
Standard Deviation 1.30
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
EOT
|
-1.59 units on a scale
Standard Deviation 1.38
|
-2.01 units on a scale
Standard Deviation 1.41
|
-2.13 units on a scale
Standard Deviation 1.45
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 24
|
-1.92 units on a scale
Standard Deviation 1.18
|
-2.66 units on a scale
Standard Deviation 1.34
|
-2.93 units on a scale
Standard Deviation 1.20
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 28
|
-2.03 units on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 32
|
-1.97 units on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 36
|
-2.08 units on a scale
Standard Deviation 1.10
|
-2.79 units on a scale
Standard Deviation 1.34
|
-3.01 units on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 40
|
-2.12 units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 44
|
-2.24 units on a scale
Standard Deviation 1.16
|
—
|
—
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 48
|
-2.22 units on a scale
Standard Deviation 1.19
|
-2.77 units on a scale
Standard Deviation 1.31
|
-3.08 units on a scale
Standard Deviation 1.17
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 60
|
-2.25 units on a scale
Standard Deviation 1.19
|
-2.71 units on a scale
Standard Deviation 1.37
|
-3.06 units on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 72
|
-2.35 units on a scale
Standard Deviation 1.32
|
-2.88 units on a scale
Standard Deviation 1.34
|
-3.13 units on a scale
Standard Deviation 1.16
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 84
|
-2.41 units on a scale
Standard Deviation 1.28
|
-2.77 units on a scale
Standard Deviation 1.37
|
-3.12 units on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 96
|
-2.49 units on a scale
Standard Deviation 1.24
|
-2.82 units on a scale
Standard Deviation 1.35
|
-3.16 units on a scale
Standard Deviation 1.11
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 108
|
-2.57 units on a scale
Standard Deviation 1.28
|
-2.88 units on a scale
Standard Deviation 1.41
|
-3.22 units on a scale
Standard Deviation 1.13
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 120
|
-2.51 units on a scale
Standard Deviation 1.33
|
-3.02 units on a scale
Standard Deviation 1.33
|
-3.17 units on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 132
|
-2.58 units on a scale
Standard Deviation 1.39
|
-2.98 units on a scale
Standard Deviation 1.48
|
-3.19 units on a scale
Standard Deviation 1.14
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 144
|
-2.67 units on a scale
Standard Deviation 1.25
|
-2.96 units on a scale
Standard Deviation 1.49
|
-3.12 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 156
|
-2.59 units on a scale
Standard Deviation 1.28
|
-3.15 units on a scale
Standard Deviation 1.40
|
-3.25 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 168
|
-2.61 units on a scale
Standard Deviation 1.27
|
-3.06 units on a scale
Standard Deviation 1.58
|
-3.16 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 180
|
-2.57 units on a scale
Standard Deviation 1.37
|
-3.14 units on a scale
Standard Deviation 1.52
|
-3.34 units on a scale
Standard Deviation 1.21
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 192
|
-2.70 units on a scale
Standard Deviation 1.32
|
-3.14 units on a scale
Standard Deviation 1.51
|
-3.14 units on a scale
Standard Deviation 1.27
|
|
Change From Baseline of Preceding Study in DAS28-CRP Through Week 372
Week 204
|
-2.76 units on a scale
Standard Deviation 1.17
|
-3.52 units on a scale
Standard Deviation NA
Standard Deviation (SD) not estimable as there is only one participant.
|
-4.01 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 24
|
-1.96 units on a scale
Standard Deviation 1.17
|
-2.71 units on a scale
Standard Deviation 1.40
|
-2.99 units on a scale
Standard Deviation 1.29
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 0
|
-0.70 units on a scale
Standard Deviation 1.09
|
-2.70 units on a scale
Standard Deviation 1.40
|
-2.83 units on a scale
Standard Deviation 1.30
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 2
|
-1.03 units on a scale
Standard Deviation 1.12
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 4
|
-1.11 units on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 8
|
-1.43 units on a scale
Standard Deviation 1.12
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 12
|
-1.66 units on a scale
Standard Deviation 1.19
|
-2.68 units on a scale
Standard Deviation 1.41
|
-2.90 units on a scale
Standard Deviation 1.33
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 16
|
-1.83 units on a scale
Standard Deviation 1.21
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 20
|
-1.88 units on a scale
Standard Deviation 1.19
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 28
|
-2.05 units on a scale
Standard Deviation 1.15
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 32
|
-2.03 units on a scale
Standard Deviation 1.24
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 36
|
-2.14 units on a scale
Standard Deviation 1.16
|
-2.85 units on a scale
Standard Deviation 1.44
|
-3.07 units on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 40
|
-2.18 units on a scale
Standard Deviation 1.19
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 44
|
-2.28 units on a scale
Standard Deviation 1.18
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 48
|
-2.28 units on a scale
Standard Deviation 1.22
|
-2.82 units on a scale
Standard Deviation 1.42
|
-3.13 units on a scale
Standard Deviation 1.27
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 60
|
-2.32 units on a scale
Standard Deviation 1.26
|
-2.78 units on a scale
Standard Deviation 1.46
|
-3.11 units on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 120
|
-2.54 units on a scale
Standard Deviation 1.39
|
-3.05 units on a scale
Standard Deviation 1.48
|
-3.26 units on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 132
|
-2.67 units on a scale
Standard Deviation 1.44
|
-2.98 units on a scale
Standard Deviation 1.58
|
-3.33 units on a scale
Standard Deviation 1.24
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 72
|
-2.39 units on a scale
Standard Deviation 1.37
|
-2.91 units on a scale
Standard Deviation 1.44
|
-3.22 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 84
|
-2.45 units on a scale
Standard Deviation 1.33
|
-2.81 units on a scale
Standard Deviation 1.46
|
-3.20 units on a scale
Standard Deviation 1.28
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 96
|
-2.59 units on a scale
Standard Deviation 1.32
|
-2.84 units on a scale
Standard Deviation 1.45
|
-3.21 units on a scale
Standard Deviation 1.18
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 108
|
-2.64 units on a scale
Standard Deviation 1.35
|
-2.92 units on a scale
Standard Deviation 1.52
|
-3.31 units on a scale
Standard Deviation 1.25
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 144
|
-2.76 units on a scale
Standard Deviation 1.30
|
-3.00 units on a scale
Standard Deviation 1.59
|
-3.30 units on a scale
Standard Deviation 1.36
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 156
|
-2.67 units on a scale
Standard Deviation 1.34
|
-3.14 units on a scale
Standard Deviation 1.52
|
-3.32 units on a scale
Standard Deviation 1.40
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 168
|
-2.68 units on a scale
Standard Deviation 1.32
|
-3.13 units on a scale
Standard Deviation 1.69
|
-3.18 units on a scale
Standard Deviation 1.27
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 180
|
-2.64 units on a scale
Standard Deviation 1.40
|
-3.08 units on a scale
Standard Deviation 1.80
|
-3.38 units on a scale
Standard Deviation 1.31
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 192
|
-2.73 units on a scale
Standard Deviation 1.35
|
-3.25 units on a scale
Standard Deviation 1.52
|
-3.11 units on a scale
Standard Deviation 1.32
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 204
|
-2.79 units on a scale
Standard Deviation 1.20
|
-3.04 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
-4.29 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 216
|
-2.73 units on a scale
Standard Deviation 1.32
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 228
|
-2.80 units on a scale
Standard Deviation 1.35
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 240
|
-2.83 units on a scale
Standard Deviation 1.37
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 252
|
-2.83 units on a scale
Standard Deviation 1.38
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 264
|
-2.75 units on a scale
Standard Deviation 1.39
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 276
|
-2.84 units on a scale
Standard Deviation 1.27
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 288
|
-2.77 units on a scale
Standard Deviation 1.35
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 300
|
-2.76 units on a scale
Standard Deviation 1.34
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 312
|
-2.77 units on a scale
Standard Deviation 1.32
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 324
|
-2.84 units on a scale
Standard Deviation 1.25
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 336
|
-2.62 units on a scale
Standard Deviation 1.29
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 348
|
-2.52 units on a scale
Standard Deviation 1.33
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 360
|
-3.07 units on a scale
Standard Deviation 1.17
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
Week 372
|
-5.13 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
EOT
|
-2.14 units on a scale
Standard Deviation 1.61
|
-2.69 units on a scale
Standard Deviation 1.62
|
-3.11 units on a scale
Standard Deviation 1.37
|
|
Change From Baseline of Preceding Studies in DAS28-ESR Through Week 372
EOS
|
-1.58 units on a scale
Standard Deviation 1.43
|
-2.00 units on a scale
Standard Deviation 1.37
|
-2.13 units on a scale
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP \<2.6 = remission, DAS28-CRP \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 144
|
60.0 percentage of participants
|
66.0 percentage of participants
|
74.8 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 168
|
61.2 percentage of participants
|
62.2 percentage of participants
|
72.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 192
|
64.0 percentage of participants
|
87.5 percentage of participants
|
68.2 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
EOT
|
45.3 percentage of participants
|
57.2 percentage of participants
|
69.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
EOS
|
22.8 percentage of participants
|
35.4 percentage of participants
|
44.9 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 96
|
54.7 percentage of participants
|
63.6 percentage of participants
|
71.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 108
|
51.1 percentage of participants
|
62.8 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 0
|
8.0 percentage of participants
|
55.4 percentage of participants
|
58.2 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 2
|
13.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 4
|
16.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 8
|
15.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 12
|
20.2 percentage of participants
|
53.9 percentage of participants
|
60.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 120
|
57.7 percentage of participants
|
66.9 percentage of participants
|
76.1 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 16
|
23.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 20
|
27.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 24
|
26.2 percentage of participants
|
56.3 percentage of participants
|
62.2 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 132
|
55.6 percentage of participants
|
65.5 percentage of participants
|
74.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 28
|
29.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 32
|
29.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 36
|
30.8 percentage of participants
|
58.3 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 40
|
36.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 44
|
39.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 48
|
39.3 percentage of participants
|
56.3 percentage of participants
|
69.2 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 60
|
43.9 percentage of participants
|
57.1 percentage of participants
|
66.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 72
|
46.7 percentage of participants
|
63.9 percentage of participants
|
71.1 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 360
|
81.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 372
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 84
|
51.4 percentage of participants
|
60.6 percentage of participants
|
70.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 156
|
59.7 percentage of participants
|
71.4 percentage of participants
|
72.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 180
|
58.8 percentage of participants
|
66.7 percentage of participants
|
82.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 204
|
65.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 216
|
63.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 228
|
61.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 240
|
65.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 252
|
66.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 264
|
62.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 276
|
70.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 288
|
63.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 300
|
67.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 312
|
65.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 324
|
71.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 336
|
60.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score < 2.6 Through Week 372
Week 348
|
65.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR \<2.6 = remission, DAS28-ESR \<= 3.2 implied low disease activity and \>3.2 to 5.1 implied moderate to high disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 32
|
16.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 40
|
17.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 108
|
32.3 percentage of participants
|
47.6 percentage of participants
|
52.1 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 264
|
32.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
EOS
|
14.9 percentage of participants
|
20.0 percentage of participants
|
20.2 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 0
|
4.5 percentage of participants
|
30.9 percentage of participants
|
38.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 2
|
4.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 4
|
7.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 8
|
7.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 12
|
12.1 percentage of participants
|
36.1 percentage of participants
|
39.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 16
|
13.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 20
|
12.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 120
|
31.5 percentage of participants
|
46.6 percentage of participants
|
49.8 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 132
|
34.9 percentage of participants
|
47.8 percentage of participants
|
54.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 144
|
35.0 percentage of participants
|
48.5 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 24
|
13.9 percentage of participants
|
35.3 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 28
|
18.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 36
|
18.6 percentage of participants
|
37.4 percentage of participants
|
45.8 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 44
|
20.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 48
|
20.9 percentage of participants
|
39.1 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 60
|
22.9 percentage of participants
|
36.1 percentage of participants
|
45.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 72
|
28.7 percentage of participants
|
47.3 percentage of participants
|
51.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 84
|
26.6 percentage of participants
|
41.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 96
|
34.6 percentage of participants
|
39.5 percentage of participants
|
48.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 156
|
32.8 percentage of participants
|
48.6 percentage of participants
|
53.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 168
|
36.2 percentage of participants
|
54.1 percentage of participants
|
47.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 180
|
33.6 percentage of participants
|
38.1 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 192
|
39.1 percentage of participants
|
37.5 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 204
|
35.5 percentage of participants
|
0.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 216
|
35.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 228
|
43.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 240
|
37.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 252
|
40.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 276
|
38.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 288
|
41.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 300
|
35.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 312
|
38.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 324
|
39.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 336
|
32.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 348
|
27.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 360
|
31.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
Week 372
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score < 2.6 Through Week 372
EOT
|
27.4 percentage of participants
|
42.9 percentage of participants
|
49.8 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-CRP \<2.6 = remission.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 132
|
77.0 percentage of participants
|
84.5 percentage of participants
|
87.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 108
|
77.4 percentage of participants
|
78.0 percentage of participants
|
87.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 120
|
74.6 percentage of participants
|
85.1 percentage of participants
|
86.9 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 144
|
81.7 percentage of participants
|
82.5 percentage of participants
|
86.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 156
|
78.2 percentage of participants
|
80.0 percentage of participants
|
85.8 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 168
|
76.7 percentage of participants
|
78.4 percentage of participants
|
86.8 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 180
|
75.4 percentage of participants
|
81.0 percentage of participants
|
89.1 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 192
|
76.6 percentage of participants
|
87.5 percentage of participants
|
90.9 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 204
|
83.2 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 216
|
75.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 228
|
82.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 240
|
80.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 252
|
77.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 264
|
82.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 276
|
86.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 288
|
83.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 300
|
82.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 312
|
83.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 324
|
84.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 336
|
77.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 348
|
80.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 0
|
18.5 percentage of participants
|
73.7 percentage of participants
|
72.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 2
|
24.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 4
|
25.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 8
|
33.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 12
|
38.9 percentage of participants
|
73.1 percentage of participants
|
74.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 16
|
42.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 20
|
46.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 24
|
49.7 percentage of participants
|
72.1 percentage of participants
|
78.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 28
|
51.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 32
|
50.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 36
|
56.4 percentage of participants
|
75.2 percentage of participants
|
79.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 40
|
59.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 44
|
60.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 48
|
61.3 percentage of participants
|
75.6 percentage of participants
|
82.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 360
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
EOT
|
61.7 percentage of participants
|
71.6 percentage of participants
|
84.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
EOS
|
40.6 percentage of participants
|
47.7 percentage of participants
|
60.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 60
|
64.3 percentage of participants
|
75.9 percentage of participants
|
83.1 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 72
|
64.7 percentage of participants
|
79.8 percentage of participants
|
84.5 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 84
|
68.6 percentage of participants
|
79.4 percentage of participants
|
83.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-CRP Score <= 3.2 Through Week 372
Week 96
|
75.2 percentage of participants
|
80.3 percentage of participants
|
86.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA, and calculated according to description: DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. DAS28-ESR \<2.6 = remission.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 0
|
8.5 percentage of participants
|
56.5 percentage of participants
|
55.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 2
|
13.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 4
|
14.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 8
|
14.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 12
|
22.7 percentage of participants
|
53.0 percentage of participants
|
59.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 16
|
22.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 20
|
23.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 24
|
28.3 percentage of participants
|
54.1 percentage of participants
|
62.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 28
|
29.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 32
|
31.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 36
|
32.0 percentage of participants
|
58.3 percentage of participants
|
64.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 40
|
30.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 44
|
38.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 288
|
57.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 300
|
60.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 312
|
57.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 48
|
40.5 percentage of participants
|
58.4 percentage of participants
|
65.9 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 60
|
40.1 percentage of participants
|
57.6 percentage of participants
|
67.3 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 72
|
43.3 percentage of participants
|
59.9 percentage of participants
|
69.9 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 84
|
43.9 percentage of participants
|
57.9 percentage of participants
|
69.8 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 96
|
53.7 percentage of participants
|
56.4 percentage of participants
|
71.2 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 108
|
51.9 percentage of participants
|
64.0 percentage of participants
|
70.8 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 120
|
48.5 percentage of participants
|
66.2 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 132
|
55.6 percentage of participants
|
67.0 percentage of participants
|
72.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 144
|
58.3 percentage of participants
|
63.9 percentage of participants
|
71.1 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 324
|
60.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 336
|
52.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 348
|
52.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 360
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
EOT
|
42.8 percentage of participants
|
54.5 percentage of participants
|
67.5 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
EOS
|
23.8 percentage of participants
|
35.4 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 156
|
55.5 percentage of participants
|
67.1 percentage of participants
|
67.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 168
|
56.0 percentage of participants
|
64.9 percentage of participants
|
69.7 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 180
|
57.5 percentage of participants
|
57.1 percentage of participants
|
75.6 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 192
|
55.5 percentage of participants
|
62.5 percentage of participants
|
68.2 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 204
|
60.7 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 216
|
54.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 228
|
59.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 240
|
60.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 252
|
60.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 264
|
56.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving DAS28-ESR Score <= 3.2 Through Week 372
Week 276
|
62.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
The participants were examined for the tender joints and the location was confirmed by the investigator who assessed the following 68 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher TJC indicated greater disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 180
|
-11.3 tender joint count
Standard Deviation 8.5
|
-12.2 tender joint count
Standard Deviation 7.5
|
-14.2 tender joint count
Standard Deviation 9.9
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 276
|
-12.0 tender joint count
Standard Deviation 8.4
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
EOT
|
-10.2 tender joint count
Standard Deviation 9.6
|
-11.5 tender joint count
Standard Deviation 9.4
|
-12.6 tender joint count
Standard Deviation 8.6
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
EOS
|
-8.6 tender joint count
Standard Deviation 9.8
|
-9.1 tender joint count
Standard Deviation 7.6
|
-9.4 tender joint count
Standard Deviation 9.9
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 0
|
-4.3 tender joint count
Standard Deviation 8.2
|
-11.7 tender joint count
Standard Deviation 8.8
|
-11.5 tender joint count
Standard Deviation 8.4
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 2
|
-5.3 tender joint count
Standard Deviation 7.9
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 4
|
-5.7 tender joint count
Standard Deviation 8.6
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 8
|
-7.7 tender joint count
Standard Deviation 8.8
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 12
|
-8.7 tender joint count
Standard Deviation 8.5
|
-11.8 tender joint count
Standard Deviation 8.9
|
-11.8 tender joint count
Standard Deviation 8.1
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 16
|
-9.4 tender joint count
Standard Deviation 8.3
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 20
|
-9.5 tender joint count
Standard Deviation 8.4
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 24
|
-9.8 tender joint count
Standard Deviation 9.0
|
-11.9 tender joint count
Standard Deviation 8.8
|
-12.1 tender joint count
Standard Deviation 8.0
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 28
|
-10.0 tender joint count
Standard Deviation 8.7
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 32
|
-9.5 tender joint count
Standard Deviation 8.2
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 36
|
-10.0 tender joint count
Standard Deviation 8.0
|
-12.4 tender joint count
Standard Deviation 8.8
|
-12.3 tender joint count
Standard Deviation 7.9
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 40
|
-10.4 tender joint count
Standard Deviation 8.1
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 44
|
-10.9 tender joint count
Standard Deviation 8.2
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 48
|
-10.7 tender joint count
Standard Deviation 8.3
|
-11.9 tender joint count
Standard Deviation 8.8
|
-12.3 tender joint count
Standard Deviation 8.2
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 60
|
-10.8 tender joint count
Standard Deviation 8.3
|
-11.9 tender joint count
Standard Deviation 9.2
|
-12.4 tender joint count
Standard Deviation 8.3
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 72
|
-10.4 tender joint count
Standard Deviation 8.8
|
-11.9 tender joint count
Standard Deviation 9.4
|
-12.8 tender joint count
Standard Deviation 8.5
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 84
|
-10.7 tender joint count
Standard Deviation 8.7
|
-11.9 tender joint count
Standard Deviation 9.0
|
-12.9 tender joint count
Standard Deviation 8.3
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 96
|
-10.8 tender joint count
Standard Deviation 7.9
|
-12.3 tender joint count
Standard Deviation 9.5
|
-13.1 tender joint count
Standard Deviation 8.4
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 108
|
-10.7 tender joint count
Standard Deviation 8.2
|
-12.3 tender joint count
Standard Deviation 9.3
|
-13.8 tender joint count
Standard Deviation 8.9
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 120
|
-10.6 tender joint count
Standard Deviation 8.4
|
-12.7 tender joint count
Standard Deviation 9.5
|
-13.5 tender joint count
Standard Deviation 9.2
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 132
|
-10.8 tender joint count
Standard Deviation 8.3
|
-12.8 tender joint count
Standard Deviation 9.9
|
-13.8 tender joint count
Standard Deviation 9.0
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 144
|
-11.1 tender joint count
Standard Deviation 9.0
|
-12.9 tender joint count
Standard Deviation 9.5
|
-13.3 tender joint count
Standard Deviation 9.3
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 156
|
-11.2 tender joint count
Standard Deviation 8.4
|
-14.1 tender joint count
Standard Deviation 10.4
|
-13.3 tender joint count
Standard Deviation 9.7
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 168
|
-11.3 tender joint count
Standard Deviation 8.7
|
-11.8 tender joint count
Standard Deviation 10.0
|
-13.2 tender joint count
Standard Deviation 9.1
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 192
|
-11.4 tender joint count
Standard Deviation 8.7
|
-11.8 tender joint count
Standard Deviation 5.6
|
-13.2 tender joint count
Standard Deviation 10.8
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 204
|
-11.8 tender joint count
Standard Deviation 7.8
|
-8.0 tender joint count
Standard Deviation NA
SD not estimable as there is only one participant.
|
-17.0 tender joint count
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 216
|
-11.7 tender joint count
Standard Deviation 8.1
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 228
|
-11.7 tender joint count
Standard Deviation 7.9
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 240
|
-11.7 tender joint count
Standard Deviation 8.0
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 252
|
-11.8 tender joint count
Standard Deviation 8.3
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 264
|
-11.7 tender joint count
Standard Deviation 8.4
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 288
|
-11.5 tender joint count
Standard Deviation 8.5
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 300
|
-11.5 tender joint count
Standard Deviation 8.6
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 312
|
-11.9 tender joint count
Standard Deviation 8.6
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 324
|
-12.0 tender joint count
Standard Deviation 8.2
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 336
|
-11.5 tender joint count
Standard Deviation 6.6
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 348
|
-11.2 tender joint count
Standard Deviation 5.8
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 360
|
-13.8 tender joint count
Standard Deviation 5.6
|
—
|
—
|
|
Change From Baseline of Preceding Study in Tender Joint Count (TJC) (68 Joints) Through Week 372
Week 372
|
-23.0 tender joint count
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
The participants were examined for the swollen joints and the location was confirmed by the investigator who assessed the following 66 joints which included temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). Higher SJC indicated greater disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 180
|
-9.2 swollen joint count
Standard Deviation 5.4
|
-10.6 swollen joint count
Standard Deviation 6.2
|
-11.9 swollen joint count
Standard Deviation 7.3
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 0
|
-3.8 swollen joint count
Standard Deviation 5.5
|
-9.6 swollen joint count
Standard Deviation 6.9
|
-10.5 swollen joint count
Standard Deviation 6.4
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 2
|
-4.6 swollen joint count
Standard Deviation 5.8
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 4
|
-4.8 swollen joint count
Standard Deviation 6.2
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 8
|
-6.1 swollen joint count
Standard Deviation 6.3
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 12
|
-6.7 swollen joint count
Standard Deviation 6.1
|
-9.5 swollen joint count
Standard Deviation 6.6
|
-10.4 swollen joint count
Standard Deviation 6.4
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 16
|
-7.1 swollen joint count
Standard Deviation 5.8
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 20
|
-7.4 swollen joint count
Standard Deviation 6.1
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 24
|
-7.6 swollen joint count
Standard Deviation 5.9
|
-9.9 swollen joint count
Standard Deviation 6.4
|
-10.8 swollen joint count
Standard Deviation 6.4
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 28
|
-7.6 swollen joint count
Standard Deviation 6.0
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 36
|
-7.9 swollen joint count
Standard Deviation 5.5
|
-10.3 swollen joint count
Standard Deviation 6.6
|
-11.1 swollen joint count
Standard Deviation 6.5
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 32
|
-7.5 swollen joint count
Standard Deviation 5.7
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 40
|
-8.1 swollen joint count
Standard Deviation 5.5
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 44
|
-8.6 swollen joint count
Standard Deviation 5.4
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 48
|
-8.7 swollen joint count
Standard Deviation 5.6
|
-10.4 swollen joint count
Standard Deviation 6.4
|
-11.0 swollen joint count
Standard Deviation 6.7
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 60
|
-8.4 swollen joint count
Standard Deviation 6.1
|
-10.3 swollen joint count
Standard Deviation 6.8
|
-11.1 swollen joint count
Standard Deviation 6.6
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 72
|
-8.6 swollen joint count
Standard Deviation 5.8
|
-10.3 swollen joint count
Standard Deviation 6.6
|
-11.3 swollen joint count
Standard Deviation 6.7
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 84
|
-8.7 swollen joint count
Standard Deviation 5.6
|
-10.2 swollen joint count
Standard Deviation 6.7
|
-11.2 swollen joint count
Standard Deviation 6.6
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 96
|
-8.8 swollen joint count
Standard Deviation 5.2
|
-10.6 swollen joint count
Standard Deviation 7.0
|
-11.3 swollen joint count
Standard Deviation 6.5
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 108
|
-9.0 swollen joint count
Standard Deviation 5.3
|
-10.7 swollen joint count
Standard Deviation 7.5
|
-11.5 swollen joint count
Standard Deviation 6.9
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 120
|
-8.7 swollen joint count
Standard Deviation 5.8
|
-11.1 swollen joint count
Standard Deviation 7.3
|
-11.4 swollen joint count
Standard Deviation 6.6
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 132
|
-9.0 swollen joint count
Standard Deviation 5.7
|
-11.2 swollen joint count
Standard Deviation 7.3
|
-11.5 swollen joint count
Standard Deviation 6.8
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 144
|
-9.1 swollen joint count
Standard Deviation 5.6
|
-11.2 swollen joint count
Standard Deviation 7.8
|
-11.3 swollen joint count
Standard Deviation 6.7
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 156
|
-8.9 swollen joint count
Standard Deviation 5.7
|
-12.4 swollen joint count
Standard Deviation 8.1
|
-11.4 swollen joint count
Standard Deviation 7.0
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 168
|
-9.2 swollen joint count
Standard Deviation 5.9
|
-11.4 swollen joint count
Standard Deviation 7.0
|
-11.7 swollen joint count
Standard Deviation 6.8
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 204
|
-9.5 swollen joint count
Standard Deviation 5.5
|
-6.0 swollen joint count
Standard Deviation NA
SD not estimable as there is only one participant.
|
-17.0 swollen joint count
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 192
|
-9.1 swollen joint count
Standard Deviation 5.7
|
-9.0 swollen joint count
Standard Deviation 7.3
|
-11.3 swollen joint count
Standard Deviation 7.5
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 216
|
-9.2 swollen joint count
Standard Deviation 6.0
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 228
|
-9.4 swollen joint count
Standard Deviation 5.4
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 240
|
-9.7 swollen joint count
Standard Deviation 5.8
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 252
|
-9.6 swollen joint count
Standard Deviation 5.7
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 264
|
-9.7 swollen joint count
Standard Deviation 5.5
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 276
|
-9.9 swollen joint count
Standard Deviation 5.5
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 288
|
-9.5 swollen joint count
Standard Deviation 5.7
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 300
|
-9.7 swollen joint count
Standard Deviation 5.7
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 312
|
-9.4 swollen joint count
Standard Deviation 5.8
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 324
|
-9.5 swollen joint count
Standard Deviation 5.7
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 336
|
-9.4 swollen joint count
Standard Deviation 5.3
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 348
|
-9.4 swollen joint count
Standard Deviation 5.1
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 360
|
-11.0 swollen joint count
Standard Deviation 5.8
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
Week 372
|
-18.0 swollen joint count
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
EOT
|
-7.8 swollen joint count
Standard Deviation 6.6
|
-9.7 swollen joint count
Standard Deviation 7.1
|
-11.1 swollen joint count
Standard Deviation 6.8
|
|
Change From Baseline of Preceding Study in Swollen Joint Count (SJC) (66 Joints) Through Week 372
EOS
|
-6.3 swollen joint count
Standard Deviation 7.2
|
-8.2 swollen joint count
Standard Deviation 7.4
|
-9.3 swollen joint count
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144,156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
Higher CRP indicates greater disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 0
|
-0.334 mg/dL
Standard Deviation 1.691
|
-1.590 mg/dL
Standard Deviation 2.106
|
-1.932 mg/dL
Standard Deviation 2.014
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 2
|
-0.752 mg/dL
Standard Deviation 1.724
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 4
|
-0.745 mg/dL
Standard Deviation 1.897
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 8
|
-1.032 mg/dL
Standard Deviation 1.932
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 12
|
-1.034 mg/dL
Standard Deviation 2.225
|
-1.528 mg/dL
Standard Deviation 2.121
|
-1.932 mg/dL
Standard Deviation 2.037
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 16
|
-1.176 mg/dL
Standard Deviation 2.203
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 20
|
-1.242 mg/dL
Standard Deviation 2.221
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 24
|
-1.237 mg/dL
Standard Deviation 2.168
|
-1.507 mg/dL
Standard Deviation 2.129
|
-1.991 mg/dL
Standard Deviation 2.125
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 28
|
-1.376 mg/dL
Standard Deviation 2.039
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 32
|
-1.296 mg/dL
Standard Deviation 2.040
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 36
|
-1.330 mg/dL
Standard Deviation 2.073
|
-1.552 mg/dL
Standard Deviation 2.087
|
-2.031 mg/dL
Standard Deviation 2.116
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 40
|
-1.361 mg/dL
Standard Deviation 2.217
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 44
|
-1.361 mg/dL
Standard Deviation 2.260
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 48
|
-1.367 mg/dL
Standard Deviation 2.070
|
-1.604 mg/dL
Standard Deviation 2.096
|
-2.088 mg/dL
Standard Deviation 2.034
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 60
|
-1.310 mg/dL
Standard Deviation 2.011
|
-1.534 mg/dL
Standard Deviation 2.163
|
-2.063 mg/dL
Standard Deviation 2.062
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 72
|
-1.456 mg/dL
Standard Deviation 2.165
|
-1.726 mg/dL
Standard Deviation 2.008
|
-2.019 mg/dL
Standard Deviation 2.023
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 84
|
-1.418 mg/dL
Standard Deviation 2.159
|
-1.501 mg/dL
Standard Deviation 2.337
|
-1.991 mg/dL
Standard Deviation 2.092
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 96
|
-1.485 mg/dL
Standard Deviation 2.113
|
-1.561 mg/dL
Standard Deviation 2.101
|
-1.983 mg/dL
Standard Deviation 2.606
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 108
|
-1.562 mg/dL
Standard Deviation 2.060
|
-1.565 mg/dL
Standard Deviation 2.444
|
-2.066 mg/dL
Standard Deviation 1.990
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 120
|
-1.507 mg/dL
Standard Deviation 2.199
|
-1.730 mg/dL
Standard Deviation 2.163
|
-1.964 mg/dL
Standard Deviation 2.108
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 132
|
-1.443 mg/dL
Standard Deviation 2.602
|
-1.519 mg/dL
Standard Deviation 2.231
|
-2.058 mg/dL
Standard Deviation 2.178
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 144
|
-1.609 mg/dL
Standard Deviation 2.297
|
-1.474 mg/dL
Standard Deviation 2.155
|
-2.120 mg/dL
Standard Deviation 2.329
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 156
|
-1.423 mg/dL
Standard Deviation 2.489
|
-1.731 mg/dL
Standard Deviation 1.892
|
-2.432 mg/dL
Standard Deviation 2.277
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 168
|
-1.576 mg/dL
Standard Deviation 2.213
|
-1.418 mg/dL
Standard Deviation 2.153
|
-2.211 mg/dL
Standard Deviation 2.227
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 180
|
-1.170 mg/dL
Standard Deviation 2.340
|
-2.088 mg/dL
Standard Deviation 1.984
|
-2.230 mg/dL
Standard Deviation 2.053
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 192
|
-1.506 mg/dL
Standard Deviation 1.976
|
-1.501 mg/dL
Standard Deviation 1.575
|
-2.060 mg/dL
Standard Deviation 2.014
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 204
|
-1.477 mg/dL
Standard Deviation 2.154
|
-1.570 mg/dL
Standard Deviation NA
SD not estimable as there is only one participant.
|
-0.950 mg/dL
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 216
|
-1.374 mg/dL
Standard Deviation 2.209
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 228
|
-1.449 mg/dL
Standard Deviation 2.232
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 240
|
-1.440 mg/dL
Standard Deviation 2.340
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 252
|
-1.488 mg/dL
Standard Deviation 2.263
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 264
|
-1.498 mg/dL
Standard Deviation 2.379
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 276
|
-1.647 mg/dL
Standard Deviation 2.264
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 288
|
-1.580 mg/dL
Standard Deviation 2.404
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 300
|
-1.537 mg/dL
Standard Deviation 2.470
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 312
|
-1.263 mg/dL
Standard Deviation 2.319
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 324
|
-1.565 mg/dL
Standard Deviation 2.238
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 336
|
-1.452 mg/dL
Standard Deviation 2.189
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 348
|
-1.365 mg/dL
Standard Deviation 2.015
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 360
|
-2.179 mg/dL
Standard Deviation 2.117
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
Week 372
|
-2.330 mg/dL
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
EOT
|
-1.072 mg/dL
Standard Deviation 2.470
|
-1.386 mg/dL
Standard Deviation 2.340
|
-1.845 mg/dL
Standard Deviation 2.438
|
|
Change From Baseline of Preceding Study in CRP (mg/dL) Through Week 372
EOS
|
-0.967 mg/dL
Standard Deviation 2.251
|
-1.262 mg/dL
Standard Deviation 2.930
|
-1.270 mg/dL
Standard Deviation 2.818
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
Higher ESR indicates greater disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 180
|
-16.28 mm/h
Standard Deviation 23.48
|
-23.52 mm/h
Standard Deviation 28.44
|
-33.46 mm/h
Standard Deviation 24.70
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 192
|
-18.86 mm/h
Standard Deviation 20.85
|
-38.63 mm/h
Standard Deviation 35.76
|
-26.50 mm/h
Standard Deviation 27.72
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 44
|
-15.60 mm/h
Standard Deviation 20.47
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 0
|
-2.46 mm/h
Standard Deviation 17.83
|
-22.66 mm/h
Standard Deviation 25.31
|
-27.02 mm/h
Standard Deviation 23.11
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 2
|
-6.65 mm/h
Standard Deviation 18.03
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 4
|
-6.93 mm/h
Standard Deviation 18.01
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 8
|
-10.54 mm/h
Standard Deviation 17.93
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 12
|
-11.93 mm/h
Standard Deviation 18.44
|
-22.43 mm/h
Standard Deviation 26.18
|
-27.72 mm/h
Standard Deviation 23.47
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 16
|
-13.39 mm/h
Standard Deviation 19.30
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 20
|
-14.07 mm/h
Standard Deviation 17.92
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 24
|
-14.45 mm/h
Standard Deviation 18.12
|
-22.91 mm/h
Standard Deviation 25.13
|
-28.54 mm/h
Standard Deviation 24.45
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 28
|
-15.15 mm/h
Standard Deviation 17.28
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 32
|
-16.20 mm/h
Standard Deviation 17.74
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 36
|
-16.26 mm/h
Standard Deviation 19.70
|
-22.51 mm/h
Standard Deviation 26.62
|
-29.41 mm/h
Standard Deviation 23.34
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 40
|
-16.27 mm/h
Standard Deviation 19.89
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 48
|
-16.09 mm/h
Standard Deviation 19.14
|
-23.63 mm/h
Standard Deviation 25.51
|
-30.31 mm/h
Standard Deviation 23.67
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 60
|
-16.71 mm/h
Standard Deviation 19.07
|
-23.34 mm/h
Standard Deviation 24.86
|
-30.06 mm/h
Standard Deviation 23.69
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 72
|
-16.78 mm/h
Standard Deviation 21.18
|
-24.70 mm/h
Standard Deviation 24.16
|
-30.06 mm/h
Standard Deviation 23.85
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 84
|
-16.89 mm/h
Standard Deviation 20.87
|
-22.58 mm/h
Standard Deviation 26.95
|
-29.23 mm/h
Standard Deviation 24.23
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 96
|
-18.81 mm/h
Standard Deviation 21.28
|
-21.71 mm/h
Standard Deviation 25.55
|
-29.70 mm/h
Standard Deviation 25.14
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 108
|
-19.24 mm/h
Standard Deviation 20.02
|
-22.46 mm/h
Standard Deviation 25.87
|
-29.97 mm/h
Standard Deviation 25.60
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 120
|
-19.48 mm/h
Standard Deviation 21.41
|
-24.36 mm/h
Standard Deviation 25.63
|
-29.46 mm/h
Standard Deviation 25.87
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 132
|
-19.43 mm/h
Standard Deviation 23.78
|
-22.13 mm/h
Standard Deviation 26.42
|
-30.35 mm/h
Standard Deviation 24.34
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 144
|
-22.19 mm/h
Standard Deviation 22.29
|
-21.48 mm/h
Standard Deviation 22.87
|
-31.44 mm/h
Standard Deviation 24.17
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 156
|
-20.62 mm/h
Standard Deviation 23.11
|
-23.14 mm/h
Standard Deviation 23.91
|
-30.77 mm/h
Standard Deviation 25.02
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 168
|
-20.58 mm/h
Standard Deviation 22.98
|
-24.95 mm/h
Standard Deviation 22.89
|
-29.68 mm/h
Standard Deviation 22.86
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 204
|
-19.05 mm/h
Standard Deviation 21.63
|
-11.00 mm/h
Standard Deviation NA
SD not estimable as there is only one participant.
|
-57.00 mm/h
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 216
|
-17.85 mm/h
Standard Deviation 23.11
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 228
|
-20.09 mm/h
Standard Deviation 22.96
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 240
|
-19.24 mm/h
Standard Deviation 22.01
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 252
|
-20.78 mm/h
Standard Deviation 21.72
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 264
|
-19.11 mm/h
Standard Deviation 24.20
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 276
|
-20.21 mm/h
Standard Deviation 21.14
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 288
|
-17.57 mm/h
Standard Deviation 25.36
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 300
|
-19.51 mm/h
Standard Deviation 20.15
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 312
|
-16.81 mm/h
Standard Deviation 21.06
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 324
|
-17.28 mm/h
Standard Deviation 22.08
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 336
|
-17.51 mm/h
Standard Deviation 21.38
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 348
|
-16.53 mm/h
Standard Deviation 21.63
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 360
|
-20.63 mm/h
Standard Deviation 22.81
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
Week 372
|
-28.00 mm/h
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
EOT
|
-12.52 mm/h
Standard Deviation 21.92
|
-20.04 mm/h
Standard Deviation 26.47
|
-26.36 mm/h
Standard Deviation 27.00
|
|
Change From Baseline of Preceding Study in ESR (mm/h) Through Week 372
EOS
|
-8.90 mm/h
Standard Deviation 24.70
|
-14.48 mm/h
Standard Deviation 25.73
|
-17.26 mm/h
Standard Deviation 27.20
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤1, CRP ≤1 mg/dL, and participant's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm).
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 0
|
1.5 percentage of participants
|
18.3 percentage of participants
|
22.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 2
|
4.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 4
|
5.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 8
|
4.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 12
|
4.0 percentage of participants
|
16.9 percentage of participants
|
23.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 16
|
7.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 20
|
7.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 24
|
7.5 percentage of participants
|
20.2 percentage of participants
|
26.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 28
|
9.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 32
|
10.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 36
|
11.0 percentage of participants
|
29.1 percentage of participants
|
28.3 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 40
|
8.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 44
|
11.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 48
|
11.0 percentage of participants
|
25.9 percentage of participants
|
32.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 60
|
10.8 percentage of participants
|
24.1 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 72
|
11.3 percentage of participants
|
29.5 percentage of participants
|
30.7 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 84
|
14.3 percentage of participants
|
30.0 percentage of participants
|
34.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 96
|
17.5 percentage of participants
|
26.6 percentage of participants
|
33.2 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 108
|
18.0 percentage of participants
|
28.7 percentage of participants
|
30.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 120
|
16.9 percentage of participants
|
29.1 percentage of participants
|
26.3 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 132
|
20.6 percentage of participants
|
29.3 percentage of participants
|
31.4 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 144
|
18.3 percentage of participants
|
30.9 percentage of participants
|
28.9 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 156
|
17.6 percentage of participants
|
27.1 percentage of participants
|
31.1 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 168
|
21.6 percentage of participants
|
35.1 percentage of participants
|
31.6 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 180
|
21.1 percentage of participants
|
23.8 percentage of participants
|
34.8 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 192
|
21.6 percentage of participants
|
25.0 percentage of participants
|
31.8 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 204
|
23.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 216
|
25.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 228
|
24.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 240
|
24.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 252
|
25.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 264
|
24.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 276
|
19.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 288
|
25.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 300
|
24.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 312
|
24.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 324
|
23.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 336
|
24.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 348
|
15.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 360
|
25.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
Week 372
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
EOT
|
15.9 percentage of participants
|
25.7 percentage of participants
|
31.3 percentage of participants
|
|
Percentage of Participants Achieving ACR/European League Against Rheumatism (EULAR) Response Through Week 372
EOS
|
10.9 percentage of participants
|
7.7 percentage of participants
|
12.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good response have been reported in this outcome measure.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 0
|
11.5 percentage of participants
|
71.0 percentage of participants
|
71.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 16
|
36.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 20
|
43.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 24
|
44.4 percentage of participants
|
70.2 percentage of participants
|
77.2 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 60
|
58.0 percentage of participants
|
71.7 percentage of participants
|
82.3 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 120
|
70.8 percentage of participants
|
83.8 percentage of participants
|
85.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 144
|
78.3 percentage of participants
|
80.4 percentage of participants
|
85.2 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 2
|
18.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 4
|
19.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 8
|
27.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 12
|
34.8 percentage of participants
|
70.3 percentage of participants
|
72.3 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 28
|
47.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 32
|
46.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 36
|
49.4 percentage of participants
|
72.3 percentage of participants
|
78.2 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 40
|
53.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 44
|
53.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 48
|
56.4 percentage of participants
|
73.1 percentage of participants
|
80.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 72
|
59.3 percentage of participants
|
76.5 percentage of participants
|
84.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 84
|
63.6 percentage of participants
|
75.0 percentage of participants
|
82.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 96
|
72.3 percentage of participants
|
77.5 percentage of participants
|
84.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 108
|
72.9 percentage of participants
|
75.6 percentage of participants
|
85.8 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 132
|
73.8 percentage of participants
|
80.2 percentage of participants
|
85.7 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 156
|
74.8 percentage of participants
|
75.7 percentage of participants
|
84.9 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 168
|
73.3 percentage of participants
|
75.7 percentage of participants
|
86.8 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 180
|
71.9 percentage of participants
|
76.2 percentage of participants
|
84.8 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 192
|
74.8 percentage of participants
|
87.5 percentage of participants
|
86.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 204
|
77.6 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 216
|
73.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 228
|
79.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 240
|
78.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 252
|
76.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 264
|
80.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 276
|
81.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 288
|
78.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 300
|
80.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 312
|
81.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 324
|
79.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 336
|
71.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 348
|
75.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 360
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
EOT
|
58.7 percentage of participants
|
69.4 percentage of participants
|
83.3 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 372
EOS
|
38.6 percentage of participants
|
43.1 percentage of participants
|
58.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good response have been reported in the outcome measure.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 288
|
54.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 300
|
58.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 312
|
54.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 324
|
59.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 336
|
50.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 348
|
52.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 360
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
EOT
|
41.3 percentage of participants
|
52.2 percentage of participants
|
65.8 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
EOS
|
20.8 percentage of participants
|
35.4 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 252
|
57.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 264
|
56.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 276
|
60.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 0
|
7.0 percentage of participants
|
54.7 percentage of participants
|
54.5 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 2
|
11.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 4
|
13.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 8
|
13.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 12
|
21.7 percentage of participants
|
50.7 percentage of participants
|
58.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 16
|
21.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 20
|
23.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 24
|
27.3 percentage of participants
|
52.7 percentage of participants
|
61.6 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 28
|
29.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 32
|
30.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 36
|
30.8 percentage of participants
|
54.9 percentage of participants
|
63.7 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 40
|
28.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 44
|
36.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 48
|
38.0 percentage of participants
|
56.3 percentage of participants
|
65.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 60
|
39.5 percentage of participants
|
55.5 percentage of participants
|
66.5 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 72
|
42.7 percentage of participants
|
58.2 percentage of participants
|
68.5 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 84
|
43.9 percentage of participants
|
54.5 percentage of participants
|
68.6 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 96
|
51.5 percentage of participants
|
54.7 percentage of participants
|
69.6 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 108
|
50.4 percentage of participants
|
61.6 percentage of participants
|
68.9 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 120
|
46.2 percentage of participants
|
64.2 percentage of participants
|
69.5 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 132
|
54.0 percentage of participants
|
64.3 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 144
|
56.7 percentage of participants
|
60.8 percentage of participants
|
68.9 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 156
|
53.8 percentage of participants
|
65.7 percentage of participants
|
67.6 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 168
|
55.2 percentage of participants
|
64.9 percentage of participants
|
68.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 180
|
56.6 percentage of participants
|
57.1 percentage of participants
|
73.3 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 192
|
54.5 percentage of participants
|
62.5 percentage of participants
|
63.6 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 204
|
59.8 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 216
|
52.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 228
|
58.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good Response Using DAS28-ESR Through Week 372
Week 240
|
56.8 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 0
|
41.5 percentage of participants
|
89.7 percentage of participants
|
93.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 2
|
54.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 4
|
59.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 8
|
70.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 12
|
75.8 percentage of participants
|
91.3 percentage of participants
|
92.2 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 16
|
78.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 20
|
85.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 24
|
84.0 percentage of participants
|
92.3 percentage of participants
|
95.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 28
|
87.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 32
|
84.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 36
|
91.3 percentage of participants
|
92.2 percentage of participants
|
95.5 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 40
|
89.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 44
|
93.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 48
|
92.6 percentage of participants
|
94.4 percentage of participants
|
95.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 60
|
93.0 percentage of participants
|
92.1 percentage of participants
|
94.9 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 72
|
90.7 percentage of participants
|
91.2 percentage of participants
|
96.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 84
|
89.9 percentage of participants
|
92.7 percentage of participants
|
95.9 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 96
|
92.6 percentage of participants
|
94.2 percentage of participants
|
97.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 108
|
92.5 percentage of participants
|
91.5 percentage of participants
|
97.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 120
|
91.5 percentage of participants
|
93.9 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 132
|
92.1 percentage of participants
|
89.6 percentage of participants
|
97.7 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 144
|
93.3 percentage of participants
|
87.6 percentage of participants
|
97.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 156
|
94.1 percentage of participants
|
95.7 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 168
|
92.2 percentage of participants
|
86.5 percentage of participants
|
96.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 180
|
93.8 percentage of participants
|
90.5 percentage of participants
|
93.3 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 192
|
94.5 percentage of participants
|
87.5 percentage of participants
|
95.5 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 204
|
95.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 216
|
93.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 228
|
92.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 240
|
92.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 252
|
92.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 264
|
92.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 276
|
94.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 288
|
92.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 300
|
95.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 312
|
94.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 324
|
96.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 336
|
94.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 348
|
92.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 360
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
EOT
|
76.6 percentage of participants
|
87.1 percentage of participants
|
93.7 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-ESR Through Week 372
EOS
|
67.3 percentage of participants
|
80.0 percentage of participants
|
82.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
The Disease Activity Score Based on 28-joints Count based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1. Percentage of participants with good or moderate response have been reported in this outcome measure.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 0
|
48.5 percentage of participants
|
94.2 percentage of participants
|
94.6 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 2
|
60.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 4
|
65.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 8
|
75.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 12
|
79.8 percentage of participants
|
92.7 percentage of participants
|
94.9 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 16
|
81.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 20
|
84.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 24
|
84.5 percentage of participants
|
95.2 percentage of participants
|
96.2 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 28
|
88.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 32
|
88.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 36
|
91.3 percentage of participants
|
95.1 percentage of participants
|
96.9 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 40
|
92.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 44
|
93.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 48
|
92.0 percentage of participants
|
94.9 percentage of participants
|
97.3 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 60
|
94.9 percentage of participants
|
93.7 percentage of participants
|
96.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 72
|
92.7 percentage of participants
|
95.1 percentage of participants
|
96.3 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 84
|
92.1 percentage of participants
|
95.0 percentage of participants
|
96.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 96
|
94.2 percentage of participants
|
94.2 percentage of participants
|
97.7 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 108
|
95.5 percentage of participants
|
93.9 percentage of participants
|
98.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 120
|
93.1 percentage of participants
|
98.0 percentage of participants
|
96.7 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 132
|
92.1 percentage of participants
|
94.0 percentage of participants
|
97.7 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 144
|
95.0 percentage of participants
|
90.7 percentage of participants
|
96.3 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 156
|
94.1 percentage of participants
|
97.1 percentage of participants
|
98.1 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 168
|
94.0 percentage of participants
|
94.6 percentage of participants
|
98.7 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 180
|
93.9 percentage of participants
|
95.2 percentage of participants
|
97.8 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 192
|
95.5 percentage of participants
|
87.5 percentage of participants
|
95.5 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 204
|
96.3 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 216
|
94.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 228
|
93.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 240
|
94.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 252
|
93.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 264
|
91.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 276
|
95.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 288
|
94.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 300
|
93.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 312
|
94.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 324
|
98.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 336
|
98.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 348
|
92.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 360
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
EOT
|
78.6 percentage of participants
|
89.2 percentage of participants
|
95.4 percentage of participants
|
|
Percentage of Participants With a EULAR Good or Moderate Response Using DAS28-CRP Through Week 372
EOS
|
72.3 percentage of participants
|
80.0 percentage of participants
|
83.1 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. SDAI Remission was defined as SDAI score ≤ 3.3.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 0
|
4.0 percentage of participants
|
24.6 percentage of participants
|
32.6 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 2
|
5.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 4
|
6.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 8
|
5.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 12
|
6.1 percentage of participants
|
27.4 percentage of participants
|
31.4 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 16
|
8.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 20
|
10.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 24
|
13.4 percentage of participants
|
28.4 percentage of participants
|
37.1 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 28
|
15.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 32
|
16.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 36
|
16.9 percentage of participants
|
31.6 percentage of participants
|
40.9 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 40
|
12.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 44
|
16.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 48
|
18.4 percentage of participants
|
32.5 percentage of participants
|
42.8 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 60
|
14.0 percentage of participants
|
30.4 percentage of participants
|
41.6 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 72
|
21.3 percentage of participants
|
37.7 percentage of participants
|
43.3 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 84
|
21.4 percentage of participants
|
35.6 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 96
|
24.1 percentage of participants
|
37.6 percentage of participants
|
42.0 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 108
|
25.6 percentage of participants
|
39.6 percentage of participants
|
42.7 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 120
|
24.6 percentage of participants
|
40.5 percentage of participants
|
38.0 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 132
|
28.6 percentage of participants
|
41.4 percentage of participants
|
44.0 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 144
|
27.5 percentage of participants
|
41.2 percentage of participants
|
45.2 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 156
|
24.4 percentage of participants
|
42.9 percentage of participants
|
42.5 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 168
|
28.4 percentage of participants
|
51.4 percentage of participants
|
44.7 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 180
|
27.2 percentage of participants
|
42.9 percentage of participants
|
45.7 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 192
|
33.3 percentage of participants
|
25.0 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 204
|
30.8 percentage of participants
|
0.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 216
|
33.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 228
|
37.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 240
|
37.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 252
|
31.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 264
|
35.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 276
|
32.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 288
|
38.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 300
|
33.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 312
|
32.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 324
|
34.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 336
|
28.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 348
|
22.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 360
|
31.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
Week 372
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
EOT
|
23.9 percentage of participants
|
36.0 percentage of participants
|
43.4 percentage of participants
|
|
Percentage of Participants With a Simplified Disease Activity Index (SDAI) Score of <= 3.3 Through Week 372
EOS
|
13.9 percentage of participants
|
13.8 percentage of participants
|
24.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to description: SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 48
|
-21.17 units on a scale
Standard Deviation 11.97
|
-24.93 units on a scale
Standard Deviation 12.56
|
-26.75 units on a scale
Standard Deviation 11.98
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 60
|
-21.10 units on a scale
Standard Deviation 12.21
|
-24.54 units on a scale
Standard Deviation 13.27
|
-26.73 units on a scale
Standard Deviation 12.04
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 72
|
-21.65 units on a scale
Standard Deviation 13.09
|
-25.17 units on a scale
Standard Deviation 13.02
|
-27.31 units on a scale
Standard Deviation 12.04
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 0
|
-7.41 units on a scale
Standard Deviation 11.53
|
-24.30 units on a scale
Standard Deviation 13.03
|
-25.12 units on a scale
Standard Deviation 12.32
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 2
|
-10.13 units on a scale
Standard Deviation 11.06
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 4
|
-10.93 units on a scale
Standard Deviation 12.01
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 8
|
-14.33 units on a scale
Standard Deviation 12.03
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 12
|
-16.14 units on a scale
Standard Deviation 12.02
|
-23.93 units on a scale
Standard Deviation 13.02
|
-25.15 units on a scale
Standard Deviation 12.17
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 16
|
-17.53 units on a scale
Standard Deviation 11.95
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 20
|
-18.11 units on a scale
Standard Deviation 12.16
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 24
|
-18.61 units on a scale
Standard Deviation 11.99
|
-24.13 units on a scale
Standard Deviation 12.84
|
-25.93 units on a scale
Standard Deviation 11.90
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 28
|
-19.43 units on a scale
Standard Deviation 12.07
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 32
|
-18.66 units on a scale
Standard Deviation 12.25
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 36
|
-19.62 units on a scale
Standard Deviation 11.23
|
-25.00 units on a scale
Standard Deviation 13.12
|
-26.45 units on a scale
Standard Deviation 11.70
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 40
|
-20.26 units on a scale
Standard Deviation 11.40
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 44
|
-20.96 units on a scale
Standard Deviation 11.46
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 84
|
-21.82 units on a scale
Standard Deviation 12.90
|
-24.70 units on a scale
Standard Deviation 13.34
|
-27.15 units on a scale
Standard Deviation 12.02
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 96
|
-22.40 units on a scale
Standard Deviation 12.25
|
-25.37 units on a scale
Standard Deviation 13.36
|
-27.52 units on a scale
Standard Deviation 11.72
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 108
|
-22.73 units on a scale
Standard Deviation 12.74
|
-25.38 units on a scale
Standard Deviation 13.68
|
-28.28 units on a scale
Standard Deviation 12.38
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 120
|
-22.18 units on a scale
Standard Deviation 13.61
|
-26.57 units on a scale
Standard Deviation 13.40
|
-27.71 units on a scale
Standard Deviation 12.37
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 132
|
-22.90 units on a scale
Standard Deviation 13.51
|
-26.38 units on a scale
Standard Deviation 14.24
|
-27.83 units on a scale
Standard Deviation 12.16
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 144
|
-23.58 units on a scale
Standard Deviation 12.96
|
-26.53 units on a scale
Standard Deviation 14.75
|
-27.38 units on a scale
Standard Deviation 13.05
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 156
|
-23.19 units on a scale
Standard Deviation 13.04
|
-28.68 units on a scale
Standard Deviation 15.05
|
-28.07 units on a scale
Standard Deviation 13.27
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 168
|
-23.64 units on a scale
Standard Deviation 13.12
|
-26.75 units on a scale
Standard Deviation 15.71
|
-27.34 units on a scale
Standard Deviation 13.31
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 180
|
-23.07 units on a scale
Standard Deviation 13.37
|
-26.63 units on a scale
Standard Deviation 15.13
|
-29.04 units on a scale
Standard Deviation 13.67
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 192
|
-23.75 units on a scale
Standard Deviation 13.34
|
-24.37 units on a scale
Standard Deviation 15.48
|
-27.99 units on a scale
Standard Deviation 13.04
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 204
|
-24.42 units on a scale
Standard Deviation 12.08
|
-26.92 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
-36.00 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 216
|
-24.00 units on a scale
Standard Deviation 12.81
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 228
|
-24.18 units on a scale
Standard Deviation 12.64
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 240
|
-24.55 units on a scale
Standard Deviation 12.88
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 252
|
-24.47 units on a scale
Standard Deviation 13.18
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 264
|
-24.36 units on a scale
Standard Deviation 13.22
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 276
|
-25.23 units on a scale
Standard Deviation 12.77
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 288
|
-24.71 units on a scale
Standard Deviation 13.15
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 300
|
-24.56 units on a scale
Standard Deviation 13.46
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 312
|
-24.52 units on a scale
Standard Deviation 13.38
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 324
|
-25.45 units on a scale
Standard Deviation 12.83
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 336
|
-23.68 units on a scale
Standard Deviation 12.34
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 348
|
-22.45 units on a scale
Standard Deviation 11.80
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 360
|
-27.23 units on a scale
Standard Deviation 11.15
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
Week 372
|
-53.18 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
EOT
|
-19.12 units on a scale
Standard Deviation 15.01
|
-23.68 units on a scale
Standard Deviation 14.37
|
-26.58 units on a scale
Standard Deviation 13.07
|
|
Change From Baseline of Preceding Study in SDAI Score Through Week 372
EOS
|
-14.81 units on a scale
Standard Deviation 13.90
|
-19.25 units on a scale
Standard Deviation 14.64
|
-20.05 units on a scale
Standard Deviation 14.05
|
SECONDARY outcome
Timeframe: Baseline of preceding study, weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. CDAI. Remission was defined as CDAI score ≤ 2.8.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 24
|
11.8 percentage of participants
|
29.3 percentage of participants
|
36.0 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 28
|
14.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 32
|
16.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 36
|
15.1 percentage of participants
|
30.6 percentage of participants
|
39.1 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 40
|
13.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 44
|
15.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 48
|
19.6 percentage of participants
|
33.5 percentage of participants
|
42.2 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 60
|
14.0 percentage of participants
|
28.3 percentage of participants
|
40.7 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 0
|
3.0 percentage of participants
|
23.7 percentage of participants
|
30.6 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 2
|
4.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 4
|
4.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 8
|
6.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 12
|
5.6 percentage of participants
|
24.2 percentage of participants
|
30.6 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 16
|
7.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 20
|
8.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 72
|
18.7 percentage of participants
|
36.6 percentage of participants
|
42.4 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 84
|
20.0 percentage of participants
|
33.9 percentage of participants
|
42.6 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 96
|
23.4 percentage of participants
|
37.6 percentage of participants
|
42.7 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 108
|
26.3 percentage of participants
|
37.2 percentage of participants
|
40.4 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 120
|
23.1 percentage of participants
|
39.9 percentage of participants
|
39.0 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 132
|
25.4 percentage of participants
|
44.0 percentage of participants
|
42.3 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 144
|
25.0 percentage of participants
|
42.3 percentage of participants
|
44.9 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 156
|
19.3 percentage of participants
|
41.4 percentage of participants
|
40.6 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 168
|
28.4 percentage of participants
|
51.4 percentage of participants
|
43.4 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 180
|
28.1 percentage of participants
|
33.3 percentage of participants
|
43.5 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 192
|
30.6 percentage of participants
|
25.0 percentage of participants
|
45.5 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 204
|
29.9 percentage of participants
|
0.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 216
|
33.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 228
|
33.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 240
|
34.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 252
|
30.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 264
|
31.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 276
|
31.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 288
|
38.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 300
|
30.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 312
|
31.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 324
|
34.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 336
|
26.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 348
|
20.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 360
|
31.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
Week 372
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
EOT
|
24.9 percentage of participants
|
34.5 percentage of participants
|
42.5 percentage of participants
|
|
Percentage of Participants With a Clinical Disease Activity Index (CDAI) Score of <= 2.8 Through Week 372
EOS
|
14.9 percentage of participants
|
12.3 percentage of participants
|
25.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA (0-10 cm VAS), PGA (0-10 cm VAS), and calculated according to description: CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 20
|
-16.87 units on a scale
Standard Deviation 11.15
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 24
|
-17.37 units on a scale
Standard Deviation 11.35
|
-22.62 units on a scale
Standard Deviation 12.17
|
-23.93 units on a scale
Standard Deviation 11.24
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 0
|
-7.07 units on a scale
Standard Deviation 10.78
|
-22.70 units on a scale
Standard Deviation 12.24
|
-23.22 units on a scale
Standard Deviation 11.73
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 2
|
-9.38 units on a scale
Standard Deviation 10.44
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 4
|
-10.19 units on a scale
Standard Deviation 11.36
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 8
|
-13.30 units on a scale
Standard Deviation 11.28
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 12
|
-15.11 units on a scale
Standard Deviation 11.10
|
-22.39 units on a scale
Standard Deviation 12.28
|
-23.21 units on a scale
Standard Deviation 11.54
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 16
|
-16.35 units on a scale
Standard Deviation 10.88
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 28
|
-18.06 units on a scale
Standard Deviation 11.39
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 32
|
-17.36 units on a scale
Standard Deviation 11.37
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 36
|
-18.29 units on a scale
Standard Deviation 10.42
|
-23.41 units on a scale
Standard Deviation 12.39
|
-24.42 units on a scale
Standard Deviation 11.13
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 40
|
-18.90 units on a scale
Standard Deviation 10.50
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 44
|
-19.60 units on a scale
Standard Deviation 10.58
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 48
|
-19.80 units on a scale
Standard Deviation 11.03
|
-23.32 units on a scale
Standard Deviation 11.98
|
-24.66 units on a scale
Standard Deviation 11.45
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 60
|
-19.79 units on a scale
Standard Deviation 11.41
|
-23.01 units on a scale
Standard Deviation 12.53
|
-24.66 units on a scale
Standard Deviation 11.53
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 72
|
-20.19 units on a scale
Standard Deviation 12.16
|
-23.45 units on a scale
Standard Deviation 12.39
|
-25.29 units on a scale
Standard Deviation 11.55
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 84
|
-20.40 units on a scale
Standard Deviation 12.11
|
-23.20 units on a scale
Standard Deviation 12.61
|
-25.16 units on a scale
Standard Deviation 11.54
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 96
|
-20.92 units on a scale
Standard Deviation 11.41
|
-23.81 units on a scale
Standard Deviation 12.62
|
-25.54 units on a scale
Standard Deviation 11.27
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 108
|
-21.17 units on a scale
Standard Deviation 11.87
|
-23.81 units on a scale
Standard Deviation 12.76
|
-26.22 units on a scale
Standard Deviation 11.82
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 120
|
-20.68 units on a scale
Standard Deviation 12.79
|
-24.84 units on a scale
Standard Deviation 12.73
|
-25.74 units on a scale
Standard Deviation 11.66
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 132
|
-21.46 units on a scale
Standard Deviation 12.30
|
-24.86 units on a scale
Standard Deviation 13.57
|
-25.77 units on a scale
Standard Deviation 11.56
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 144
|
-21.97 units on a scale
Standard Deviation 11.87
|
-25.06 units on a scale
Standard Deviation 14.11
|
-25.23 units on a scale
Standard Deviation 12.10
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 156
|
-21.77 units on a scale
Standard Deviation 11.89
|
-26.95 units on a scale
Standard Deviation 14.59
|
-25.64 units on a scale
Standard Deviation 12.50
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 168
|
-22.06 units on a scale
Standard Deviation 12.12
|
-25.34 units on a scale
Standard Deviation 14.99
|
-25.13 units on a scale
Standard Deviation 12.55
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 180
|
-21.90 units on a scale
Standard Deviation 12.27
|
-24.54 units on a scale
Standard Deviation 14.26
|
-26.81 units on a scale
Standard Deviation 13.07
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 192
|
-22.24 units on a scale
Standard Deviation 12.55
|
-22.87 units on a scale
Standard Deviation 14.41
|
-25.93 units on a scale
Standard Deviation 12.65
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 204
|
-22.95 units on a scale
Standard Deviation 11.32
|
-25.35 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
-35.05 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 216
|
-22.62 units on a scale
Standard Deviation 11.84
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 228
|
-22.73 units on a scale
Standard Deviation 11.89
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 240
|
-23.11 units on a scale
Standard Deviation 11.88
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 252
|
-22.98 units on a scale
Standard Deviation 12.28
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 264
|
-22.86 units on a scale
Standard Deviation 12.21
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 276
|
-23.58 units on a scale
Standard Deviation 11.91
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 288
|
-23.13 units on a scale
Standard Deviation 12.18
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 300
|
-23.02 units on a scale
Standard Deviation 12.27
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 312
|
-23.26 units on a scale
Standard Deviation 12.34
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 324
|
-23.89 units on a scale
Standard Deviation 11.85
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 336
|
-22.23 units on a scale
Standard Deviation 11.56
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 348
|
-21.08 units on a scale
Standard Deviation 11.11
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 360
|
-25.05 units on a scale
Standard Deviation 10.77
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
Week 372
|
-50.85 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
EOT
|
-18.05 units on a scale
Standard Deviation 13.98
|
-22.24 units on a scale
Standard Deviation 13.54
|
-24.74 units on a scale
Standard Deviation 12.26
|
|
Change From Baseline of Preceding Study CDAI Score Through Week 372
EOS
|
-13.84 units on a scale
Standard Deviation 13.08
|
-17.97 units on a scale
Standard Deviation 12.75
|
-18.78 units on a scale
Standard Deviation 12.87
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, EOT, EOSPopulation: FAS population with available data at each time point. Only 015K-CL-RAJ1 arm was analyzed for this outcome as planned.
FACIT-Fatigue was used to assess the burden of self-reported fatigue caused by a chronic disease and its impact upon daily activities and function. It has 13-items with symptom-specific questions, each of the 13 items of the FACIT-Fatigue scale ranges from 0 (Not at all) - 4 (Very much), the range of possible scores is 0 - 52. Higher scores indicate higher fatigue.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
EOS
|
3.67 units on a scale
Standard Deviation 9.77
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 0
|
1.71 units on a scale
Standard Deviation 8.52
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 2
|
4.50 units on a scale
Standard Deviation 3.54
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 4
|
3.29 units on a scale
Standard Deviation 8.08
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 8
|
4.15 units on a scale
Standard Deviation 8.66
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 12
|
4.85 units on a scale
Standard Deviation 8.79
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 16
|
5.91 units on a scale
Standard Deviation 8.50
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 20
|
5.86 units on a scale
Standard Deviation 9.26
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 24
|
5.99 units on a scale
Standard Deviation 8.93
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 28
|
5.95 units on a scale
Standard Deviation 8.96
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 32
|
5.91 units on a scale
Standard Deviation 8.49
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 36
|
5.91 units on a scale
Standard Deviation 8.72
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 40
|
6.06 units on a scale
Standard Deviation 8.87
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 44
|
6.05 units on a scale
Standard Deviation 8.40
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 48
|
6.34 units on a scale
Standard Deviation 8.44
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 60
|
7.18 units on a scale
Standard Deviation 9.03
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 72
|
5.87 units on a scale
Standard Deviation 8.90
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 84
|
6.11 units on a scale
Standard Deviation 8.15
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 96
|
6.10 units on a scale
Standard Deviation 8.22
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
Week 108
|
-6.0 units on a scale
Standard Deviation NA
SD not estimable as data reported for one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score Through Week 108
EOT
|
5.95 units on a scale
Standard Deviation 9.24
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOTPopulation: FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent work time missed due to problem was calculated as Q2/(Q2+Q4). Negative values indicate improvement from baseline.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=116 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=211 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 168
|
-8.65 percent work time missed
Standard Deviation 21.30
|
-5.19 percent work time missed
Standard Deviation 19.82
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 0
|
-5.36 percent work time missed
Standard Deviation 16.76
|
-2.20 percent work time missed
Standard Deviation 18.46
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 24
|
-4.81 percent work time missed
Standard Deviation 17.40
|
-3.29 percent work time missed
Standard Deviation 14.30
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 48
|
-4.52 percent work time missed
Standard Deviation 19.86
|
-3.30 percent work time missed
Standard Deviation 17.16
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 72
|
-4.73 percent work time missed
Standard Deviation 18.43
|
-3.17 percent work time missed
Standard Deviation 15.47
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 96
|
-4.74 percent work time missed
Standard Deviation 19.00
|
-3.13 percent work time missed
Standard Deviation 14.38
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 120
|
-5.15 percent work time missed
Standard Deviation 20.38
|
-4.49 percent work time missed
Standard Deviation 17.14
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 144
|
-3.21 percent work time missed
Standard Deviation 14.26
|
-1.26 percent work time missed
Standard Deviation 20.09
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
Week 192
|
0.00 percent work time missed
Standard Deviation 0.00
|
-2.29 percent work time missed
Standard Deviation 6.62
|
—
|
|
Change From Baseline of Preceding Study in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed Through Week 192
EOT
|
-2.76 percent work time missed
Standard Deviation 20.13
|
-1.96 percent work time missed
Standard Deviation 17.64
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOTPopulation: FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent impairment while working due to problem was calculated as Q5/10. Negative values indicate improvement from baseline.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=114 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=208 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 0
|
-21.05 percent work impairment
Standard Deviation 33.06
|
-22.18 percent work impairment
Standard Deviation 28.64
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 24
|
-21.94 percent work impairment
Standard Deviation 32.60
|
-24.79 percent work impairment
Standard Deviation 26.64
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 48
|
-20.70 percent work impairment
Standard Deviation 31.82
|
-25.17 percent work impairment
Standard Deviation 27.33
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 72
|
-21.06 percent work impairment
Standard Deviation 31.47
|
-27.12 percent work impairment
Standard Deviation 27.72
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 96
|
-20.11 percent work impairment
Standard Deviation 31.39
|
-28.54 percent work impairment
Standard Deviation 26.94
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 120
|
-24.40 percent work impairment
Standard Deviation 30.15
|
-30.00 percent work impairment
Standard Deviation 29.38
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 144
|
-18.08 percent work impairment
Standard Deviation 30.62
|
-27.16 percent work impairment
Standard Deviation 31.37
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 168
|
-17.06 percent work impairment
Standard Deviation 34.96
|
-23.24 percent work impairment
Standard Deviation 31.79
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
Week 192
|
-15.00 percent work impairment
Standard Deviation 21.21
|
-28.00 percent work impairment
Standard Deviation 35.53
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Impairment While Working Through Week 192
EOT
|
-21.49 percent work impairment
Standard Deviation 33.56
|
-24.13 percent work impairment
Standard Deviation 29.46
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOTPopulation: FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work). Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent overall work impairment due to problem was calculated as Q2/(Q2+Q4)+\[(1-(Q2/(Q2+Q4))x(Q5/10)\]. Negative values indicate improvement from baseline.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=114 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=208 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 192
|
-15.00 percent overall work impairment
Standard Deviation 21.21
|
-28.06 percent overall work impairment
Standard Deviation 36.25
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
EOT
|
-20.75 percent overall work impairment
Standard Deviation 33.46
|
-24.63 percent overall work impairment
Standard Deviation 31.29
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 0
|
-22.24 percent overall work impairment
Standard Deviation 33.23
|
-22.20 percent overall work impairment
Standard Deviation 30.83
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 24
|
-22.45 percent overall work impairment
Standard Deviation 32.86
|
-25.78 percent overall work impairment
Standard Deviation 27.99
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 48
|
-20.80 percent overall work impairment
Standard Deviation 32.72
|
-25.32 percent overall work impairment
Standard Deviation 30.00
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 72
|
-21.59 percent overall work impairment
Standard Deviation 32.40
|
-27.41 percent overall work impairment
Standard Deviation 28.98
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 96
|
-20.58 percent overall work impairment
Standard Deviation 32.29
|
-28.93 percent overall work impairment
Standard Deviation 28.34
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 120
|
-24.71 percent overall work impairment
Standard Deviation 30.92
|
-31.40 percent overall work impairment
Standard Deviation 30.13
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 144
|
-18.29 percent overall work impairment
Standard Deviation 31.64
|
-26.76 percent overall work impairment
Standard Deviation 33.82
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Overall Work Impairment Through Week 192
Week 168
|
-19.03 percent overall work impairment
Standard Deviation 36.72
|
-24.76 percent overall work impairment
Standard Deviation 32.39
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 24, 48, 72, 96, 120, 144, 168, 192, EOTPopulation: FAS population with available data at each time point. Only 015K-CL-RAJ3 and 015K-CL-RAJ4 arms were analyzed for this outcome as planned.
WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicated greater activity impairment. The scores were multiplied by 100 to express in percentages. Percent activity impairment due to problem was calculated as Q6/10. Negative values indicate improvement from baseline.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=223 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=410 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 0
|
-28.16 percent activity impairment
Standard Deviation 29.69
|
-25.39 percent activity impairment
Standard Deviation 29.77
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 24
|
-27.38 percent activity impairment
Standard Deviation 30.15
|
-29.31 percent activity impairment
Standard Deviation 28.92
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 48
|
-27.81 percent activity impairment
Standard Deviation 30.76
|
-28.85 percent activity impairment
Standard Deviation 29.34
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 72
|
-28.09 percent activity impairment
Standard Deviation 31.12
|
-31.59 percent activity impairment
Standard Deviation 30.71
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 96
|
-27.92 percent activity impairment
Standard Deviation 30.69
|
-30.69 percent activity impairment
Standard Deviation 29.30
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 120
|
-29.26 percent activity impairment
Standard Deviation 31.56
|
-33.07 percent activity impairment
Standard Deviation 30.69
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 144
|
-26.39 percent activity impairment
Standard Deviation 32.57
|
-31.11 percent activity impairment
Standard Deviation 30.68
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 168
|
-20.81 percent activity impairment
Standard Deviation 26.71
|
-26.53 percent activity impairment
Standard Deviation 31.64
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
Week 192
|
-20.00 percent activity impairment
Standard Deviation 30.24
|
-23.18 percent activity impairment
Standard Deviation 32.13
|
—
|
|
Change From Baseline of Preceding Study in WPAI Percent Activity Impairment Through Week 192
EOT
|
-25.55 percent activity impairment
Standard Deviation 32.04
|
-27.87 percent activity impairment
Standard Deviation 32.40
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 72
|
60.0 percentage of participants
|
67.2 percentage of participants
|
68.8 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 156
|
65.5 percentage of participants
|
68.6 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 168
|
67.2 percentage of participants
|
73.0 percentage of participants
|
68.4 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 180
|
68.4 percentage of participants
|
71.4 percentage of participants
|
73.9 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 192
|
67.6 percentage of participants
|
87.5 percentage of participants
|
59.1 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 204
|
67.3 percentage of participants
|
100.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 252
|
68.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 288
|
70.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
EOT
|
52.7 percentage of participants
|
62.3 percentage of participants
|
63.6 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
EOS
|
35.6 percentage of participants
|
40.0 percentage of participants
|
48.3 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 0
|
37.0 percentage of participants
|
61.2 percentage of participants
|
62.1 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 2
|
38.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 4
|
38.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 8
|
39.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 12
|
42.9 percentage of participants
|
62.1 percentage of participants
|
63.0 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 16
|
46.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 20
|
47.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 24
|
48.7 percentage of participants
|
64.9 percentage of participants
|
65.5 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 28
|
50.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 32
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 36
|
51.2 percentage of participants
|
62.8 percentage of participants
|
64.3 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 40
|
52.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 44
|
55.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 48
|
54.0 percentage of participants
|
58.9 percentage of participants
|
65.4 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 60
|
55.4 percentage of participants
|
62.8 percentage of participants
|
67.1 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 84
|
62.9 percentage of participants
|
65.6 percentage of participants
|
69.2 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 96
|
62.0 percentage of participants
|
63.0 percentage of participants
|
69.1 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 108
|
62.4 percentage of participants
|
62.2 percentage of participants
|
67.4 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 120
|
63.1 percentage of participants
|
69.6 percentage of participants
|
68.1 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 132
|
66.7 percentage of participants
|
70.7 percentage of participants
|
68.0 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 144
|
66.7 percentage of participants
|
71.1 percentage of participants
|
69.9 percentage of participants
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 216
|
72.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 228
|
70.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 240
|
68.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 264
|
67.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 276
|
72.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 300
|
69.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 312
|
67.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 324
|
70.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 336
|
62.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 348
|
60.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 360
|
56.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving Health Assessment Questionnaire - Disability Index (HAQ-DI) Score <= 0.5 Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 0
|
-0.03 units on a scale
Standard Deviation 0.47
|
-0.43 units on a scale
Standard Deviation 0.57
|
-0.49 units on a scale
Standard Deviation 0.55
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 2
|
-0.07 units on a scale
Standard Deviation 0.44
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 24
|
-0.25 units on a scale
Standard Deviation 0.46
|
-0.43 units on a scale
Standard Deviation 0.60
|
-0.52 units on a scale
Standard Deviation 0.59
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 36
|
-0.25 units on a scale
Standard Deviation 0.48
|
-0.43 units on a scale
Standard Deviation 0.60
|
-0.52 units on a scale
Standard Deviation 0.56
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 48
|
-0.27 units on a scale
Standard Deviation 0.48
|
-0.42 units on a scale
Standard Deviation 0.57
|
-0.55 units on a scale
Standard Deviation 0.55
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 72
|
-0.29 units on a scale
Standard Deviation 0.51
|
-0.44 units on a scale
Standard Deviation 0.59
|
-0.56 units on a scale
Standard Deviation 0.58
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 84
|
-0.29 units on a scale
Standard Deviation 0.51
|
-0.45 units on a scale
Standard Deviation 0.59
|
-0.56 units on a scale
Standard Deviation 0.57
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 96
|
-0.29 units on a scale
Standard Deviation 0.50
|
-0.42 units on a scale
Standard Deviation 0.61
|
-0.59 units on a scale
Standard Deviation 0.58
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 228
|
-0.34 units on a scale
Standard Deviation 0.58
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 336
|
-0.31 units on a scale
Standard Deviation 0.60
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 132
|
-0.31 units on a scale
Standard Deviation 0.50
|
-0.49 units on a scale
Standard Deviation 0.59
|
-0.60 units on a scale
Standard Deviation 0.57
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 144
|
-0.33 units on a scale
Standard Deviation 0.51
|
-0.49 units on a scale
Standard Deviation 0.60
|
-0.58 units on a scale
Standard Deviation 0.53
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 156
|
-0.33 units on a scale
Standard Deviation 0.53
|
-0.52 units on a scale
Standard Deviation 0.60
|
-0.58 units on a scale
Standard Deviation 0.55
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 168
|
-0.31 units on a scale
Standard Deviation 0.53
|
-0.41 units on a scale
Standard Deviation 0.62
|
-0.51 units on a scale
Standard Deviation 0.50
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 4
|
-0.08 units on a scale
Standard Deviation 0.44
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 8
|
-0.13 units on a scale
Standard Deviation 0.47
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 12
|
-0.17 units on a scale
Standard Deviation 0.45
|
-0.44 units on a scale
Standard Deviation 0.57
|
-0.48 units on a scale
Standard Deviation 0.59
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 16
|
-0.21 units on a scale
Standard Deviation 0.45
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 20
|
-0.22 units on a scale
Standard Deviation 0.46
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 28
|
-0.27 units on a scale
Standard Deviation 0.46
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 32
|
-0.27 units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 40
|
-0.25 units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 44
|
-0.26 units on a scale
Standard Deviation 0.48
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 60
|
-0.28 units on a scale
Standard Deviation 0.50
|
-0.43 units on a scale
Standard Deviation 0.59
|
-0.55 units on a scale
Standard Deviation 0.56
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 108
|
-0.30 units on a scale
Standard Deviation 0.48
|
-0.40 units on a scale
Standard Deviation 0.62
|
-0.60 units on a scale
Standard Deviation 0.60
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 120
|
-0.30 units on a scale
Standard Deviation 0.49
|
-0.48 units on a scale
Standard Deviation 0.59
|
-0.60 units on a scale
Standard Deviation 0.58
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 180
|
-0.32 units on a scale
Standard Deviation 0.56
|
-0.29 units on a scale
Standard Deviation 0.69
|
-0.52 units on a scale
Standard Deviation 0.48
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 192
|
-0.32 units on a scale
Standard Deviation 0.53
|
-0.25 units on a scale
Standard Deviation 0.68
|
-0.44 units on a scale
Standard Deviation 0.58
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 204
|
-0.32 units on a scale
Standard Deviation 0.53
|
-0.75 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
-0.75 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 216
|
-0.35 units on a scale
Standard Deviation 0.57
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 240
|
-0.31 units on a scale
Standard Deviation 0.61
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 252
|
-0.35 units on a scale
Standard Deviation 0.55
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 264
|
-0.32 units on a scale
Standard Deviation 0.57
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 276
|
-0.36 units on a scale
Standard Deviation 0.56
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 288
|
-0.34 units on a scale
Standard Deviation 0.59
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 300
|
-0.35 units on a scale
Standard Deviation 0.59
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 312
|
-0.37 units on a scale
Standard Deviation 0.59
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 324
|
-0.35 units on a scale
Standard Deviation 0.54
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 348
|
-0.29 units on a scale
Standard Deviation 0.62
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 360
|
-0.41 units on a scale
Standard Deviation 0.58
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
Week 372
|
-0.88 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
EOT
|
-0.22 units on a scale
Standard Deviation 0.62
|
-0.37 units on a scale
Standard Deviation 0.63
|
-0.51 units on a scale
Standard Deviation 0.62
|
|
Change From Baseline of Preceding Study in HAQ-DI Through Week 372
EOS
|
-0.08 units on a scale
Standard Deviation 0.63
|
-0.17 units on a scale
Standard Deviation 0.62
|
-0.28 units on a scale
Standard Deviation 0.73
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
Participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item was scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 2
|
37.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 32
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 84
|
53.6 percentage of participants
|
63.3 percentage of participants
|
69.5 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 96
|
51.8 percentage of participants
|
57.2 percentage of participants
|
73.9 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 0
|
35.0 percentage of participants
|
59.2 percentage of participants
|
67.0 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 4
|
40.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 8
|
41.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 12
|
48.0 percentage of participants
|
61.5 percentage of participants
|
65.7 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 16
|
51.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 20
|
49.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 24
|
50.3 percentage of participants
|
59.9 percentage of participants
|
68.3 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 28
|
54.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 36
|
48.3 percentage of participants
|
55.8 percentage of participants
|
71.4 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 40
|
48.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 44
|
50.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 48
|
50.3 percentage of participants
|
58.2 percentage of participants
|
70.6 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 60
|
54.1 percentage of participants
|
59.7 percentage of participants
|
71.9 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 72
|
54.0 percentage of participants
|
59.6 percentage of participants
|
69.9 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 108
|
54.9 percentage of participants
|
56.7 percentage of participants
|
73.8 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 120
|
52.3 percentage of participants
|
62.8 percentage of participants
|
73.2 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 132
|
53.2 percentage of participants
|
57.8 percentage of participants
|
74.9 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 144
|
55.8 percentage of participants
|
61.9 percentage of participants
|
75.0 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 156
|
53.8 percentage of participants
|
70.0 percentage of participants
|
76.4 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 168
|
53.4 percentage of participants
|
62.2 percentage of participants
|
69.7 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 180
|
57.0 percentage of participants
|
47.6 percentage of participants
|
71.7 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 192
|
55.0 percentage of participants
|
50.0 percentage of participants
|
59.1 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 204
|
51.4 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 216
|
55.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 228
|
52.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 240
|
50.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 252
|
54.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 264
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 276
|
54.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 288
|
47.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 300
|
54.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 312
|
51.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 324
|
51.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 336
|
50.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 348
|
47.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 360
|
62.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
Week 372
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
EOT
|
46.8 percentage of participants
|
55.4 percentage of participants
|
68.9 percentage of participants
|
|
Percentage of Participants Achieving HAQ-DI Decrease From Baseline of at Least 0.22 Through Week 372
EOS
|
44.6 percentage of participants
|
44.6 percentage of participants
|
56.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
Participants answered: "Considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a 0 - 100 mm visual analog scale where 0 = very well and 100 = very poorly.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 60
|
-32.82 units on a scale
Standard Deviation 24.00
|
-41.84 units on a scale
Standard Deviation 23.31
|
-45.20 units on a scale
Standard Deviation 22.00
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 12
|
-24.33 units on a scale
Standard Deviation 23.00
|
-40.22 units on a scale
Standard Deviation 23.50
|
-42.77 units on a scale
Standard Deviation 23.09
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 16
|
-26.64 units on a scale
Standard Deviation 22.86
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 20
|
-27.12 units on a scale
Standard Deviation 23.28
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 24
|
-27.56 units on a scale
Standard Deviation 23.81
|
-40.65 units on a scale
Standard Deviation 24.02
|
-43.81 units on a scale
Standard Deviation 23.23
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 28
|
-29.22 units on a scale
Standard Deviation 24.18
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 32
|
-27.80 units on a scale
Standard Deviation 24.05
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 36
|
-29.94 units on a scale
Standard Deviation 22.82
|
-41.60 units on a scale
Standard Deviation 24.88
|
-44.81 units on a scale
Standard Deviation 21.41
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 40
|
-31.58 units on a scale
Standard Deviation 21.55
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 44
|
-31.60 units on a scale
Standard Deviation 22.50
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 48
|
-33.04 units on a scale
Standard Deviation 23.41
|
-41.92 units on a scale
Standard Deviation 23.36
|
-45.71 units on a scale
Standard Deviation 21.52
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 72
|
-33.68 units on a scale
Standard Deviation 24.19
|
-42.48 units on a scale
Standard Deviation 22.83
|
-47.05 units on a scale
Standard Deviation 21.35
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 84
|
-33.39 units on a scale
Standard Deviation 25.87
|
-41.31 units on a scale
Standard Deviation 25.12
|
-46.42 units on a scale
Standard Deviation 22.33
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 96
|
-34.12 units on a scale
Standard Deviation 23.79
|
-43.26 units on a scale
Standard Deviation 24.46
|
-47.35 units on a scale
Standard Deviation 21.98
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 108
|
-35.70 units on a scale
Standard Deviation 24.63
|
-43.55 units on a scale
Standard Deviation 23.34
|
-48.04 units on a scale
Standard Deviation 22.43
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 120
|
-35.14 units on a scale
Standard Deviation 25.13
|
-45.11 units on a scale
Standard Deviation 23.65
|
-46.99 units on a scale
Standard Deviation 22.76
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 132
|
-37.24 units on a scale
Standard Deviation 25.90
|
-45.51 units on a scale
Standard Deviation 24.94
|
-47.50 units on a scale
Standard Deviation 20.77
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 144
|
-39.11 units on a scale
Standard Deviation 24.31
|
-45.70 units on a scale
Standard Deviation 27.19
|
-45.85 units on a scale
Standard Deviation 22.35
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 156
|
-37.72 units on a scale
Standard Deviation 24.91
|
-48.04 units on a scale
Standard Deviation 25.43
|
-46.65 units on a scale
Standard Deviation 21.24
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 0
|
-10.77 units on a scale
Standard Deviation 21.64
|
-41.57 units on a scale
Standard Deviation 22.92
|
-43.09 units on a scale
Standard Deviation 23.21
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 2
|
-13.48 units on a scale
Standard Deviation 20.82
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 4
|
-16.78 units on a scale
Standard Deviation 21.81
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 8
|
-20.59 units on a scale
Standard Deviation 23.69
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 168
|
-39.55 units on a scale
Standard Deviation 24.87
|
-45.54 units on a scale
Standard Deviation 24.77
|
-45.07 units on a scale
Standard Deviation 22.38
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 180
|
-37.34 units on a scale
Standard Deviation 25.47
|
-44.62 units on a scale
Standard Deviation 29.00
|
-46.01 units on a scale
Standard Deviation 20.30
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 192
|
-39.13 units on a scale
Standard Deviation 24.79
|
-33.75 units on a scale
Standard Deviation 36.86
|
-44.50 units on a scale
Standard Deviation 19.39
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 204
|
-40.46 units on a scale
Standard Deviation 22.73
|
-30.00 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
-53.50 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 216
|
-40.80 units on a scale
Standard Deviation 23.52
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 228
|
-40.08 units on a scale
Standard Deviation 23.25
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 240
|
-41.67 units on a scale
Standard Deviation 24.00
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 252
|
-41.55 units on a scale
Standard Deviation 23.74
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 264
|
-41.13 units on a scale
Standard Deviation 24.71
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 276
|
-42.46 units on a scale
Standard Deviation 22.75
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 288
|
-42.21 units on a scale
Standard Deviation 25.60
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 300
|
-41.40 units on a scale
Standard Deviation 22.39
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 312
|
-42.18 units on a scale
Standard Deviation 22.71
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 324
|
-42.73 units on a scale
Standard Deviation 22.93
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 336
|
-39.55 units on a scale
Standard Deviation 25.31
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 348
|
-38.71 units on a scale
Standard Deviation 24.27
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 360
|
-40.25 units on a scale
Standard Deviation 18.36
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
Week 372
|
-47.00 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
EOT
|
-30.72 units on a scale
Standard Deviation 27.55
|
-39.86 units on a scale
Standard Deviation 26.19
|
-45.04 units on a scale
Standard Deviation 24.76
|
|
Change From Baseline of Preceding Study in Physician's Global Assessment of Arthritis (PGA) Through Week 372
EOS
|
-20.31 units on a scale
Standard Deviation 26.25
|
-30.01 units on a scale
Standard Deviation 25.67
|
-36.11 units on a scale
Standard Deviation 27.05
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
EOS
|
-18.67 units on a scale
Standard Deviation 29.38
|
-27.86 units on a scale
Standard Deviation 33.15
|
-22.79 units on a scale
Standard Deviation 30.38
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
EOT
|
-26.04 units on a scale
Standard Deviation 31.99
|
-33.53 units on a scale
Standard Deviation 32.73
|
-36.57 units on a scale
Standard Deviation 28.95
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 0
|
-6.82 units on a scale
Standard Deviation 25.41
|
-37.24 units on a scale
Standard Deviation 29.85
|
-35.60 units on a scale
Standard Deviation 26.98
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 2
|
-11.31 units on a scale
Standard Deviation 24.37
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 4
|
-13.42 units on a scale
Standard Deviation 25.21
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 8
|
-17.89 units on a scale
Standard Deviation 27.08
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 12
|
-20.60 units on a scale
Standard Deviation 26.15
|
-36.80 units on a scale
Standard Deviation 30.55
|
-34.81 units on a scale
Standard Deviation 27.68
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 16
|
-23.45 units on a scale
Standard Deviation 27.01
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 20
|
-24.35 units on a scale
Standard Deviation 27.63
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 24
|
-24.78 units on a scale
Standard Deviation 26.98
|
-37.13 units on a scale
Standard Deviation 30.97
|
-36.25 units on a scale
Standard Deviation 27.07
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 28
|
-27.29 units on a scale
Standard Deviation 27.34
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 32
|
-27.78 units on a scale
Standard Deviation 28.04
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 36
|
-27.45 units on a scale
Standard Deviation 27.10
|
-37.33 units on a scale
Standard Deviation 30.74
|
-37.57 units on a scale
Standard Deviation 25.19
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 40
|
-29.23 units on a scale
Standard Deviation 27.43
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 44
|
-29.01 units on a scale
Standard Deviation 27.10
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 48
|
-29.80 units on a scale
Standard Deviation 27.43
|
-36.12 units on a scale
Standard Deviation 29.92
|
-37.40 units on a scale
Standard Deviation 26.38
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 60
|
-30.39 units on a scale
Standard Deviation 28.54
|
-36.18 units on a scale
Standard Deviation 30.34
|
-37.46 units on a scale
Standard Deviation 26.55
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 72
|
-31.18 units on a scale
Standard Deviation 28.44
|
-36.86 units on a scale
Standard Deviation 29.67
|
-38.42 units on a scale
Standard Deviation 25.49
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 84
|
-29.73 units on a scale
Standard Deviation 30.45
|
-35.33 units on a scale
Standard Deviation 31.10
|
-38.26 units on a scale
Standard Deviation 25.81
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 96
|
-32.65 units on a scale
Standard Deviation 30.12
|
-35.75 units on a scale
Standard Deviation 30.98
|
-38.50 units on a scale
Standard Deviation 27.57
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 108
|
-31.75 units on a scale
Standard Deviation 30.27
|
-35.54 units on a scale
Standard Deviation 31.35
|
-39.69 units on a scale
Standard Deviation 26.38
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 120
|
-31.87 units on a scale
Standard Deviation 29.95
|
-38.88 units on a scale
Standard Deviation 29.82
|
-39.56 units on a scale
Standard Deviation 27.28
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 132
|
-32.61 units on a scale
Standard Deviation 31.77
|
-38.66 units on a scale
Standard Deviation 30.54
|
-37.79 units on a scale
Standard Deviation 27.53
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 144
|
-33.67 units on a scale
Standard Deviation 29.23
|
-38.99 units on a scale
Standard Deviation 31.62
|
-37.44 units on a scale
Standard Deviation 27.31
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 156
|
-34.15 units on a scale
Standard Deviation 30.71
|
-39.62 units on a scale
Standard Deviation 29.17
|
-38.45 units on a scale
Standard Deviation 26.52
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 168
|
-33.59 units on a scale
Standard Deviation 30.34
|
-38.36 units on a scale
Standard Deviation 28.96
|
-38.89 units on a scale
Standard Deviation 26.37
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 180
|
-33.56 units on a scale
Standard Deviation 30.55
|
-38.41 units on a scale
Standard Deviation 32.82
|
-38.41 units on a scale
Standard Deviation 25.29
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 192
|
-34.94 units on a scale
Standard Deviation 29.42
|
-49.90 units on a scale
Standard Deviation 33.93
|
-42.09 units on a scale
Standard Deviation 25.39
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 204
|
-35.65 units on a scale
Standard Deviation 29.79
|
-83.50 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
-57.00 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 216
|
-33.69 units on a scale
Standard Deviation 32.20
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 228
|
-34.81 units on a scale
Standard Deviation 32.30
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 240
|
-35.14 units on a scale
Standard Deviation 31.35
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 252
|
-34.84 units on a scale
Standard Deviation 31.90
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 264
|
-34.57 units on a scale
Standard Deviation 33.12
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 276
|
-36.39 units on a scale
Standard Deviation 30.81
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 288
|
-35.51 units on a scale
Standard Deviation 32.04
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 300
|
-36.97 units on a scale
Standard Deviation 33.07
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 312
|
-37.52 units on a scale
Standard Deviation 30.54
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 324
|
-35.50 units on a scale
Standard Deviation 30.28
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 336
|
-33.11 units on a scale
Standard Deviation 29.66
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 348
|
-28.87 units on a scale
Standard Deviation 31.14
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 360
|
-40.29 units on a scale
Standard Deviation 28.74
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis (SGA) Through Week 372
Week 372
|
-71.50 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOT, EOSPopulation: FAS population with available data at each time point.
The participant assessed his/her own pain severity on a visual analog scale (VAS) of 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicated greater activity pain.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 264
|
-34.81 units on a scale
Standard Deviation 34.02
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 276
|
-36.12 units on a scale
Standard Deviation 32.40
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 288
|
-34.63 units on a scale
Standard Deviation 33.46
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
EOS
|
-19.77 units on a scale
Standard Deviation 28.17
|
-29.87 units on a scale
Standard Deviation 31.05
|
-21.54 units on a scale
Standard Deviation 30.66
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 16
|
-23.12 units on a scale
Standard Deviation 26.94
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 20
|
-24.00 units on a scale
Standard Deviation 27.30
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 24
|
-24.41 units on a scale
Standard Deviation 26.68
|
-36.38 units on a scale
Standard Deviation 30.17
|
-36.17 units on a scale
Standard Deviation 27.15
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 0
|
-7.37 units on a scale
Standard Deviation 25.85
|
-36.09 units on a scale
Standard Deviation 30.09
|
-34.79 units on a scale
Standard Deviation 26.98
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 2
|
-11.21 units on a scale
Standard Deviation 23.60
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 4
|
-13.10 units on a scale
Standard Deviation 24.45
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 8
|
-17.70 units on a scale
Standard Deviation 26.93
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 12
|
-20.54 units on a scale
Standard Deviation 25.98
|
-35.75 units on a scale
Standard Deviation 30.36
|
-34.27 units on a scale
Standard Deviation 28.19
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 28
|
-26.74 units on a scale
Standard Deviation 27.81
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 32
|
-27.41 units on a scale
Standard Deviation 28.35
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 36
|
-26.73 units on a scale
Standard Deviation 28.04
|
-36.68 units on a scale
Standard Deviation 30.38
|
-37.30 units on a scale
Standard Deviation 26.59
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 40
|
-28.62 units on a scale
Standard Deviation 28.43
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 44
|
-29.08 units on a scale
Standard Deviation 27.27
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 48
|
-30.08 units on a scale
Standard Deviation 27.09
|
-35.88 units on a scale
Standard Deviation 30.24
|
-37.16 units on a scale
Standard Deviation 26.89
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 60
|
-30.88 units on a scale
Standard Deviation 28.64
|
-35.77 units on a scale
Standard Deviation 30.45
|
-36.93 units on a scale
Standard Deviation 27.51
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 72
|
-30.47 units on a scale
Standard Deviation 28.23
|
-36.54 units on a scale
Standard Deviation 29.83
|
-37.36 units on a scale
Standard Deviation 26.86
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 84
|
-29.41 units on a scale
Standard Deviation 31.51
|
-35.14 units on a scale
Standard Deviation 30.67
|
-37.58 units on a scale
Standard Deviation 27.07
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 96
|
-31.59 units on a scale
Standard Deviation 31.98
|
-34.55 units on a scale
Standard Deviation 30.47
|
-37.83 units on a scale
Standard Deviation 27.59
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 108
|
-31.16 units on a scale
Standard Deviation 31.19
|
-35.52 units on a scale
Standard Deviation 30.77
|
-38.72 units on a scale
Standard Deviation 26.97
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 120
|
-31.92 units on a scale
Standard Deviation 30.85
|
-38.32 units on a scale
Standard Deviation 29.85
|
-38.34 units on a scale
Standard Deviation 27.88
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 132
|
-32.42 units on a scale
Standard Deviation 31.62
|
-38.30 units on a scale
Standard Deviation 29.75
|
-36.66 units on a scale
Standard Deviation 26.60
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 144
|
-33.53 units on a scale
Standard Deviation 31.99
|
-39.02 units on a scale
Standard Deviation 29.85
|
-36.34 units on a scale
Standard Deviation 25.75
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 156
|
-33.61 units on a scale
Standard Deviation 31.76
|
-40.11 units on a scale
Standard Deviation 29.13
|
-37.08 units on a scale
Standard Deviation 26.55
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 168
|
-34.24 units on a scale
Standard Deviation 32.17
|
-38.27 units on a scale
Standard Deviation 28.57
|
-36.96 units on a scale
Standard Deviation 26.23
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 180
|
-33.40 units on a scale
Standard Deviation 32.56
|
-42.90 units on a scale
Standard Deviation 30.70
|
-37.85 units on a scale
Standard Deviation 25.95
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 192
|
-34.50 units on a scale
Standard Deviation 30.26
|
-50.81 units on a scale
Standard Deviation 36.83
|
-40.86 units on a scale
Standard Deviation 28.24
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 204
|
-35.88 units on a scale
Standard Deviation 30.63
|
-82.50 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
-58.00 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 216
|
-33.21 units on a scale
Standard Deviation 33.60
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 228
|
-34.44 units on a scale
Standard Deviation 33.92
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 240
|
-34.98 units on a scale
Standard Deviation 32.39
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 252
|
-34.88 units on a scale
Standard Deviation 33.20
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 300
|
-35.73 units on a scale
Standard Deviation 34.47
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 312
|
-35.42 units on a scale
Standard Deviation 33.21
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 324
|
-33.43 units on a scale
Standard Deviation 34.58
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 336
|
-32.56 units on a scale
Standard Deviation 32.27
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 348
|
-25.96 units on a scale
Standard Deviation 33.18
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 360
|
-35.59 units on a scale
Standard Deviation 26.94
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
Week 372
|
-58.60 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Subject's Global Assessment of Arthritis Pain (SGAP) Through Week 372
EOT
|
-26.57 units on a scale
Standard Deviation 32.59
|
-33.82 units on a scale
Standard Deviation 32.32
|
-35.84 units on a scale
Standard Deviation 30.02
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOTPopulation: FAS population with available data at each time point.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=223 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 0
|
-0.55 units on a scale
Standard Deviation 13.12
|
11.62 units on a scale
Standard Deviation 12.80
|
11.60 units on a scale
Standard Deviation 12.48
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 4
|
0.30 units on a scale
Standard Deviation 13.81
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 8
|
1.53 units on a scale
Standard Deviation 12.85
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 12
|
2.52 units on a scale
Standard Deviation 13.47
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 16
|
4.10 units on a scale
Standard Deviation 13.36
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 20
|
3.72 units on a scale
Standard Deviation 14.22
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 24
|
3.56 units on a scale
Standard Deviation 13.69
|
12.55 units on a scale
Standard Deviation 13.84
|
13.23 units on a scale
Standard Deviation 12.43
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 28
|
3.97 units on a scale
Standard Deviation 14.13
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 32
|
4.14 units on a scale
Standard Deviation 13.35
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 36
|
3.63 units on a scale
Standard Deviation 14.08
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 40
|
4.27 units on a scale
Standard Deviation 13.92
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 44
|
4.49 units on a scale
Standard Deviation 13.26
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 48
|
4.51 units on a scale
Standard Deviation 13.42
|
12.31 units on a scale
Standard Deviation 13.60
|
13.52 units on a scale
Standard Deviation 12.11
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 60
|
5.89 units on a scale
Standard Deviation 13.46
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 72
|
4.94 units on a scale
Standard Deviation 14.02
|
12.35 units on a scale
Standard Deviation 14.10
|
13.48 units on a scale
Standard Deviation 13.23
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 84
|
5.59 units on a scale
Standard Deviation 13.30
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 96
|
5.02 units on a scale
Standard Deviation 14.20
|
12.15 units on a scale
Standard Deviation 14.95
|
14.20 units on a scale
Standard Deviation 13.16
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 108
|
0.27 units on a scale
Standard Deviation 14.50
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 120
|
5.01 units on a scale
Standard Deviation 14.34
|
12.59 units on a scale
Standard Deviation 15.29
|
14.59 units on a scale
Standard Deviation 13.37
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 132
|
-7.23 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 144
|
6.94 units on a scale
Standard Deviation 14.43
|
12.46 units on a scale
Standard Deviation 14.20
|
14.38 units on a scale
Standard Deviation 13.42
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 156
|
-31.60 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 168
|
6.46 units on a scale
Standard Deviation 15.80
|
9.64 units on a scale
Standard Deviation 12.16
|
13.94 units on a scale
Standard Deviation 13.97
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 192
|
6.43 units on a scale
Standard Deviation 14.75
|
10.42 units on a scale
Standard Deviation 16.12
|
12.60 units on a scale
Standard Deviation 12.95
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 216
|
6.73 units on a scale
Standard Deviation 15.24
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 240
|
6.13 units on a scale
Standard Deviation 16.19
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 264
|
5.97 units on a scale
Standard Deviation 17.28
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 276
|
-22.64 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 288
|
6.21 units on a scale
Standard Deviation 16.43
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 300
|
4.73 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 312
|
6.13 units on a scale
Standard Deviation 16.23
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 324
|
21.10 units on a scale
Standard Deviation 23.80
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 336
|
4.33 units on a scale
Standard Deviation 15.78
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 348
|
-5.21 units on a scale
Standard Deviation 13.68
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 360
|
6.92 units on a scale
Standard Deviation 9.75
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
Week 372
|
0.16 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score Through Week 372
EOT
|
3.44 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
10.29 units on a scale
Standard Deviation 15.46
|
12.62 units on a scale
Standard Deviation 13.23
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOTPopulation: FAS population with available data at each time point.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=223 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 120
|
4.64 units on a scale
Standard Deviation 8.73
|
2.40 units on a scale
Standard Deviation 8.67
|
1.62 units on a scale
Standard Deviation 9.24
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 0
|
3.00 units on a scale
Standard Deviation 8.40
|
2.94 units on a scale
Standard Deviation 8.52
|
2.69 units on a scale
Standard Deviation 8.67
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 4
|
3.88 units on a scale
Standard Deviation 8.86
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 8
|
3.85 units on a scale
Standard Deviation 9.51
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 12
|
4.72 units on a scale
Standard Deviation 9.08
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 16
|
4.61 units on a scale
Standard Deviation 9.25
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 20
|
4.97 units on a scale
Standard Deviation 9.18
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 24
|
6.01 units on a scale
Standard Deviation 9.13
|
2.02 units on a scale
Standard Deviation 9.15
|
2.61 units on a scale
Standard Deviation 9.04
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 28
|
5.38 units on a scale
Standard Deviation 9.74
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 32
|
5.13 units on a scale
Standard Deviation 9.20
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 36
|
5.18 units on a scale
Standard Deviation 9.05
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 40
|
5.70 units on a scale
Standard Deviation 9.27
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 44
|
5.79 units on a scale
Standard Deviation 9.33
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 48
|
5.52 units on a scale
Standard Deviation 9.24
|
1.74 units on a scale
Standard Deviation 8.78
|
2.89 units on a scale
Standard Deviation 8.76
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 60
|
5.27 units on a scale
Standard Deviation 9.15
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 72
|
5.28 units on a scale
Standard Deviation 8.83
|
2.87 units on a scale
Standard Deviation 9.31
|
2.80 units on a scale
Standard Deviation 8.94
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 84
|
5.58 units on a scale
Standard Deviation 9.06
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 96
|
5.42 units on a scale
Standard Deviation 9.17
|
2.10 units on a scale
Standard Deviation 8.98
|
2.22 units on a scale
Standard Deviation 9.52
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 108
|
3.89 units on a scale
Standard Deviation 7.29
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 132
|
-2.52 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 144
|
4.38 units on a scale
Standard Deviation 9.16
|
1.56 units on a scale
Standard Deviation 9.22
|
1.65 units on a scale
Standard Deviation 8.15
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 156
|
2.17 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 168
|
4.09 units on a scale
Standard Deviation 9.41
|
2.41 units on a scale
Standard Deviation 8.92
|
2.04 units on a scale
Standard Deviation 8.41
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 192
|
3.56 units on a scale
Standard Deviation 8.52
|
2.23 units on a scale
Standard Deviation 3.58
|
2.31 units on a scale
Standard Deviation 6.81
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 216
|
2.95 units on a scale
Standard Deviation 9.70
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 240
|
3.45 units on a scale
Standard Deviation 9.60
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 264
|
4.03 units on a scale
Standard Deviation 9.69
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 276
|
6.20 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 288
|
3.72 units on a scale
Standard Deviation 9.09
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 300
|
11.12 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 312
|
4.62 units on a scale
Standard Deviation 10.58
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 324
|
7.83 units on a scale
Standard Deviation 10.42
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 336
|
3.78 units on a scale
Standard Deviation 8.57
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 348
|
2.80 units on a scale
Standard Deviation 6.90
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 360
|
5.15 units on a scale
Standard Deviation 9.50
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
Week 372
|
-3.24 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Mental Component Summary Score Through Week 372
EOT
|
3.63 units on a scale
Standard Deviation 9.97
|
1.54 units on a scale
Standard Deviation 9.91
|
2.16 units on a scale
Standard Deviation 9.29
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOTPopulation: FAS population with available data at each time point.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=223 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 0
|
-0.52 units on a scale
Standard Deviation 12.29
|
5.21 units on a scale
Standard Deviation 13.96
|
5.45 units on a scale
Standard Deviation 15.40
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 96
|
2.67 units on a scale
Standard Deviation 12.51
|
4.30 units on a scale
Standard Deviation 13.56
|
5.80 units on a scale
Standard Deviation 15.61
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 4
|
0.29 units on a scale
Standard Deviation 11.16
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 8
|
1.30 units on a scale
Standard Deviation 12.39
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 12
|
1.70 units on a scale
Standard Deviation 12.00
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 16
|
2.84 units on a scale
Standard Deviation 11.58
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 20
|
2.33 units on a scale
Standard Deviation 12.73
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 24
|
1.59 units on a scale
Standard Deviation 11.27
|
5.06 units on a scale
Standard Deviation 13.55
|
5.56 units on a scale
Standard Deviation 15.36
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 28
|
2.68 units on a scale
Standard Deviation 11.73
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 32
|
3.75 units on a scale
Standard Deviation 11.55
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 36
|
1.66 units on a scale
Standard Deviation 12.08
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 40
|
2.42 units on a scale
Standard Deviation 12.57
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 44
|
1.93 units on a scale
Standard Deviation 12.08
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 48
|
2.85 units on a scale
Standard Deviation 11.64
|
5.06 units on a scale
Standard Deviation 14.54
|
5.80 units on a scale
Standard Deviation 15.27
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 60
|
3.05 units on a scale
Standard Deviation 12.65
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 72
|
2.56 units on a scale
Standard Deviation 12.84
|
5.65 units on a scale
Standard Deviation 13.93
|
6.37 units on a scale
Standard Deviation 15.33
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 84
|
0.81 units on a scale
Standard Deviation 12.75
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 108
|
-1.62 units on a scale
Standard Deviation 1.64
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 120
|
2.97 units on a scale
Standard Deviation 12.90
|
4.55 units on a scale
Standard Deviation 14.28
|
5.92 units on a scale
Standard Deviation 16.32
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 132
|
-5.25 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 144
|
2.64 units on a scale
Standard Deviation 12.95
|
5.18 units on a scale
Standard Deviation 14.52
|
5.43 units on a scale
Standard Deviation 15.59
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 156
|
5.75 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 168
|
2.88 units on a scale
Standard Deviation 12.83
|
0.50 units on a scale
Standard Deviation 12.86
|
4.11 units on a scale
Standard Deviation 14.33
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 192
|
2.75 units on a scale
Standard Deviation 12.81
|
-0.97 units on a scale
Standard Deviation 12.36
|
2.17 units on a scale
Standard Deviation 15.20
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 216
|
3.50 units on a scale
Standard Deviation 13.80
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 240
|
3.46 units on a scale
Standard Deviation 13.20
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 264
|
2.65 units on a scale
Standard Deviation 13.28
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 276
|
1.82 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 288
|
3.99 units on a scale
Standard Deviation 12.95
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 300
|
12.34 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 312
|
3.87 units on a scale
Standard Deviation 14.89
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 324
|
15.79 units on a scale
Standard Deviation 12.43
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 336
|
3.54 units on a scale
Standard Deviation 13.56
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 348
|
-1.11 units on a scale
Standard Deviation 12.48
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 360
|
1.64 units on a scale
Standard Deviation 12.72
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
Week 372
|
-8.61 units on a scale
Standard Deviation NA
SD not estimable as there is only one participant.
|
—
|
—
|
|
Change From Baseline of Preceding Study in SF-36v2 Role/Social Component Summary Score Through Week 372
EOT
|
2.06 units on a scale
Standard Deviation 14.35
|
3.92 units on a scale
Standard Deviation 13.85
|
4.74 units on a scale
Standard Deviation 16.31
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOTPopulation: FAS population with available data at each time point.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=223 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 84
|
50.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 96
|
43.8 percentage of participants
|
71.7 percentage of participants
|
75.9 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 0
|
34.0 percentage of participants
|
70 percentage of participants
|
71.1 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 4
|
33.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 8
|
40.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 12
|
39.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 16
|
43.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 20
|
40.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 24
|
44.4 percentage of participants
|
70.5 percentage of participants
|
74.1 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 28
|
42.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 32
|
44.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 36
|
45.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 40
|
47.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 44
|
47.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 48
|
45.4 percentage of participants
|
73.0 percentage of participants
|
74.7 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 60
|
47.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 72
|
47.7 percentage of participants
|
68.3 percentage of participants
|
73.9 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 108
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 120
|
44.6 percentage of participants
|
68.2 percentage of participants
|
79.3 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 132
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 144
|
53.3 percentage of participants
|
66.0 percentage of participants
|
82.4 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 156
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 168
|
50.0 percentage of participants
|
70.3 percentage of participants
|
77.6 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 192
|
52.3 percentage of participants
|
62.5 percentage of participants
|
77.3 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 216
|
51.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 240
|
53.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 264
|
52.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 276
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 288
|
48.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 300
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 312
|
48.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 324
|
66.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 336
|
43.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 348
|
11.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 360
|
56.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
Week 372
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Physical Component Summary Score of Difference >= 5 Through Week 372
EOT
|
41.8 percentage of participants
|
61.0 percentage of participants
|
306 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOTPopulation: FAS population with available data at each time point.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=223 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 96
|
49.6 percentage of participants
|
33.5 percentage of participants
|
38.4 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 108
|
50.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 120
|
45.4 percentage of participants
|
37.2 percentage of participants
|
33.8 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 132
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 144
|
47.5 percentage of participants
|
30.9 percentage of participants
|
28.7 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 156
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 168
|
41.4 percentage of participants
|
32.4 percentage of participants
|
34.2 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
EOT
|
39.8 percentage of participants
|
35.8 percentage of participants
|
34.6 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 192
|
39.6 percentage of participants
|
37.5 percentage of participants
|
31.8 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 216
|
37.5 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 240
|
42.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 264
|
43.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 276
|
100 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 288
|
41.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 300
|
100 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 312
|
43.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 324
|
33.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 336
|
37.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 348
|
22.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 360
|
43.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 372
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 0
|
43.0 percentage of participants
|
39.9 percentage of participants
|
37.4 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 4
|
42.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 8
|
47.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 12
|
43.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 16
|
45.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 20
|
45.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 24
|
51.9 percentage of participants
|
37.2 percentage of participants
|
37.6 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 28
|
47.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 32
|
48.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 36
|
47.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 40
|
49.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 44
|
49.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 48
|
51.5 percentage of participants
|
33.2 percentage of participants
|
39.2 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 60
|
48.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 72
|
53.7 percentage of participants
|
39.3 percentage of participants
|
35.8 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Mental Component Summary Score of Difference >= 5 Through Week 372
Week 84
|
57.1 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline of preceding study and weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 216, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, EOTPopulation: FAS population with available data at each time point.
The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Role/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=223 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 0
|
26.0 percentage of participants
|
44.8 percentage of participants
|
48.5 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 4
|
27.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 8
|
35.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 12
|
39.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 16
|
39.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 20
|
38.4 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 24
|
36.4 percentage of participants
|
47.8 percentage of participants
|
48.0 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 28
|
39.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 32
|
40.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 36
|
33.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 40
|
38.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 44
|
38.7 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 48
|
40.5 percentage of participants
|
46.4 percentage of participants
|
47.1 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 60
|
39.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 72
|
38.9 percentage of participants
|
47.5 percentage of participants
|
46.7 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 84
|
29.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 96
|
38.7 percentage of participants
|
42.8 percentage of participants
|
48.2 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 108
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 120
|
39.2 percentage of participants
|
45.3 percentage of participants
|
49.3 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 132
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 144
|
38.3 percentage of participants
|
51.5 percentage of participants
|
48.5 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 156
|
100 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 168
|
39.7 percentage of participants
|
35.1 percentage of participants
|
40.8 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 192
|
38.7 percentage of participants
|
25.0 percentage of participants
|
31.8 percentage of participants
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 216
|
40.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 240
|
41.1 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 264
|
37.8 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 276
|
0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 288
|
42.9 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 300
|
100.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 312
|
45.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 324
|
83.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 336
|
39.6 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 348
|
22.2 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 360
|
31.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
Week 372
|
0.0 percentage of participants
|
—
|
—
|
|
Percentage of Participants Achieving SF-36v2 Role/Social Component Summary Score of Difference >= 5 Through Week 372
EOT
|
39.8 percentage of participants
|
43.1 percentage of participants
|
44.7 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to week 372Population: FAS
Participants who discontinued due to lack of efficacy have been reported.
Outcome measures
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 Participants
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible crietria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=224 Participants
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=412 Participants
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Number of Participants Who Withdrew Due to Lack of Efficacy
|
19.4 percentage of participants
|
4.9 percentage of participants
|
3.4 percentage of participants
|
Adverse Events
Participants Who Completed 015K-CL-RAJ1
Serious events: 59 serious events
Other events: 181 other events
Deaths: 0 deaths
Participants Who Completed 015K-CL-RAJ3
Serious events: 56 serious events
Other events: 174 other events
Deaths: 1 deaths
Participants Who Completed 015K-CL-RAJ4
Serious events: 84 serious events
Other events: 358 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 participants at risk
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=225 participants at risk
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=417 participants at risk
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Cardiac disorders
Angina pectoris
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Cardiac disorders
Coronary artery stenosis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Congenital, familial and genetic disorders
Ankyloglossia congenital
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Congenital, familial and genetic disorders
Odontogenic cyst
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Congenital, familial and genetic disorders
Urachal abnormality
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Ear and labyrinth disorders
Vertigo
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Endocrine disorders
Hyperparathyroidism
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Endocrine disorders
Steroid withdrawal syndrome
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Eye disorders
Cataract
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Eye disorders
Glaucoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Eye disorders
Maculopathy
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Eye disorders
Pterygium
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Colitis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Colonic polyp
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Periodontitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.72%
3/417 • Number of events 3 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
General disorders
Chest pain
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
General disorders
Gait disturbance
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
General disorders
Impaired healing
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
General disorders
Pyrexia
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.72%
3/417 • Number of events 3 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Arthritis bacterial
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Cellulitis
|
1.00%
2/201 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Chronic tonsillitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Dacryocystitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Empyema
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Epiglottitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Erysipelas
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Herpes zoster
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.8%
4/225 • Number of events 4 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
2.2%
9/417 • Number of events 9 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Herpes zoster disseminated
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Herpes zoster oticus
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Infective spondylitis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Keratitis herpetic
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Liver abscess
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Lung infection
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Meningitis bacterial
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pilonidal cyst
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pneumonia
|
1.00%
2/201 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
2.7%
6/225 • Number of events 6 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pyelonephritis acute
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pyoderma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Sepsis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Sinusitis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.89%
2/225 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Subdiaphragmatic abscess
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.89%
2/225 • Number of events 3 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Urosepsis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Viral infection
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Cerebral haemorrhage traumatic
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Dislocation of vertebra
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.00%
2/201 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Fractured ischium
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Ligament injury
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
2.0%
4/201 • Number of events 5 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.96%
4/417 • Number of events 4 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
1.00%
2/201 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Investigations
Bronchoscopy
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Investigations
Endoscopy large bowel
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Investigations
Liver function test abnormal
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Investigations
Weight increased
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Metabolism and nutrition disorders
Feeding disorder
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.5%
3/201 • Number of events 3 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Jaw disorder
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.89%
2/225 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign gastrointestinal neoplasm
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bone neoplasm
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage 0
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extraskeletal chondrosarcoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
1.00%
2/201 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.89%
2/225 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large intestine carcinoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Liposarcoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.72%
3/417 • Number of events 3 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian adenoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.89%
2/225 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer stage unspecified
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Nervous system disorders
Facial palsy
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Nervous system disorders
Lacunar infarction
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Nervous system disorders
Thrombotic cerebral infarction
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Psychiatric disorders
Depression
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Psychiatric disorders
Suicide attempt
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Renal and urinary disorders
Calculus ureteric
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.3%
3/225 • Number of events 3 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.00%
2/201 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Surgical and medical procedures
Ankle operation
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.44%
1/225 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Surgical and medical procedures
Cataract operation
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.48%
2/417 • Number of events 2 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Surgical and medical procedures
Intestinal polypectomy
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Surgical and medical procedures
Jaw operation
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Surgical and medical procedures
Peripheral nerve neurostimulation
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.50%
1/201 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/417 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/201 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.00%
0/225 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
0.24%
1/417 • Number of events 1 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
Other adverse events
| Measure |
Participants Who Completed 015K-CL-RAJ1
n=201 participants at risk
Participants who completed 015K-CL-RAJ1 (NCT02305849) study and met eligible criteria received starting dose of 50mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ3
n=225 participants at risk
Participants who completed 015K-CL-RAJ3 (NCT02308163) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
Participants Who Completed 015K-CL-RAJ4
n=417 participants at risk
Participants who completed 015K-CL-RAJ4 (NCT02305849) study and met eligible criteria received 100mg peficitinib tablet orally once daily after breakfast. Dose can be increased to 100mg or 150mg, and decreased to 50mg. For participants who did not have any safety problem, the dose was increased from 50 mg to 100 mg. For participants who did not have any safety problems, and confirmed a lack of clinical response (DAS28-ESR \>= 3.2 after 4 weeks of peficitinib treatment), dose was increased to 150mg. The treatment was given in this study up to 6 months after peficitinib was approved.
|
|---|---|---|---|
|
Eye disorders
Dry eye
|
6.0%
12/201 • Number of events 13 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.3%
3/225 • Number of events 3 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.2%
5/417 • Number of events 5 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Constipation
|
10.4%
21/201 • Number of events 23 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.2%
14/225 • Number of events 15 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.0%
25/417 • Number of events 27 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Dental caries
|
9.5%
19/201 • Number of events 24 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
5.8%
13/225 • Number of events 16 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
7.0%
29/417 • Number of events 38 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
16/201 • Number of events 18 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.0%
9/225 • Number of events 16 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
2.9%
12/417 • Number of events 14 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Gastritis
|
6.0%
12/201 • Number of events 12 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
3.6%
8/225 • Number of events 8 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.7%
7/417 • Number of events 7 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Nausea
|
6.0%
12/201 • Number of events 13 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.9%
11/225 • Number of events 11 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.3%
18/417 • Number of events 22 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Gastrointestinal disorders
Periodontitis
|
6.5%
13/201 • Number of events 16 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.0%
9/225 • Number of events 9 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
3.1%
13/417 • Number of events 14 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
3.5%
7/201 • Number of events 8 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
3.1%
7/225 • Number of events 8 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.5%
27/417 • Number of events 27 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Bronchitis
|
14.4%
29/201 • Number of events 76 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
9.8%
22/225 • Number of events 30 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.7%
28/417 • Number of events 32 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Cystitis
|
8.5%
17/201 • Number of events 35 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
7.6%
17/225 • Number of events 25 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.5%
27/417 • Number of events 50 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Gastroenteritis
|
11.9%
24/201 • Number of events 30 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
7.1%
16/225 • Number of events 17 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
5.3%
22/417 • Number of events 30 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Herpes zoster
|
17.4%
35/201 • Number of events 36 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
15.6%
35/225 • Number of events 36 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
15.1%
63/417 • Number of events 68 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Influenza
|
17.4%
35/201 • Number of events 41 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
9.8%
22/225 • Number of events 23 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
10.6%
44/417 • Number of events 51 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Nasopharyngitis
|
54.7%
110/201 • Number of events 368 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
40.4%
91/225 • Number of events 211 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
46.8%
195/417 • Number of events 423 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Pharyngitis
|
10.9%
22/201 • Number of events 65 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.2%
14/225 • Number of events 33 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
7.9%
33/417 • Number of events 57 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Infections and infestations
Upper respiratory tract infection
|
11.4%
23/201 • Number of events 76 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.7%
15/225 • Number of events 26 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.2%
26/417 • Number of events 38 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Injury, poisoning and procedural complications
Contusion
|
10.9%
22/201 • Number of events 26 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
7.6%
17/225 • Number of events 19 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
8.4%
35/417 • Number of events 39 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Investigations
Blood creatine phosphokinase increased
|
14.4%
29/201 • Number of events 47 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
10.2%
23/225 • Number of events 35 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
10.8%
45/417 • Number of events 55 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Investigations
Lymphocyte count decreased
|
4.0%
8/201 • Number of events 8 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
3.1%
7/225 • Number of events 9 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.7%
28/417 • Number of events 49 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
19/201 • Number of events 26 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
5.3%
12/225 • Number of events 15 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.7%
28/417 • Number of events 30 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
24.9%
50/201 • Number of events 78 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
12.0%
27/225 • Number of events 35 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
13.2%
55/417 • Number of events 61 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Nervous system disorders
Headache
|
8.0%
16/201 • Number of events 27 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.0%
9/225 • Number of events 12 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.6%
19/417 • Number of events 95 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
20/201 • Number of events 28 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
5.3%
12/225 • Number of events 13 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.8%
20/417 • Number of events 23 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.0%
14/201 • Number of events 24 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.3%
3/225 • Number of events 3 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.9%
8/417 • Number of events 8 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
8.5%
17/201 • Number of events 22 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.0%
9/225 • Number of events 13 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
2.9%
12/417 • Number of events 19 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.5%
19/201 • Number of events 26 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
4.4%
10/225 • Number of events 12 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
3.1%
13/417 • Number of events 17 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
6.5%
13/201 • Number of events 16 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.8%
4/225 • Number of events 5 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.4%
6/417 • Number of events 6 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
12/201 • Number of events 17 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
1.8%
4/225 • Number of events 4 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
3.1%
13/417 • Number of events 14 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
|
Vascular disorders
Hypertension
|
14.9%
30/201 • Number of events 30 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.2%
14/225 • Number of events 14 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
6.7%
28/417 • Number of events 29 • Baseline up to EOS (Up to 376 weeks)
Safety Population
|
Additional Information
Clinical Trial Disclosure
Astellas Pharma Inc.
Phone: +81 3-3244-6500 Japanese only
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Institute and/or Principal Investigator may publish trial data generated at their specific study site after Sponsor publication of the multi-center data. Sponsor must receive a site's manuscript prior to publication for review and comment as specified in the Investigator Agreement.
- Publication restrictions are in place
Restriction type: OTHER