Trial Outcomes & Findings for A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients (NCT NCT02260791)
NCT ID: NCT02260791
Last Updated: 2017-11-28
Results Overview
The primary efficacy endpoint was the ACR20 response rate at Week 24. An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index \[HAQ-DI\])
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
728 participants
Primary outcome timeframe
Week 24
Results posted on
2017-11-28
Participant Flow
Patients were enrolled in 109 sites in 12 countries in 3 geographical regions: North America, Europe and Rest of World. The first participant enrolled on 05 January 2015 and the last participant completed on 12 July 2016.
Screening details: Patients were randomised in a 1:1 ratio to receive either FKB327 40 mg eow or Humira 40 mg eow using the following stratification factors: prior biological treatment for Rheumatoid Arthritis (RA) (yes/no) and Screening disease activity (DAS28-CRP ≤5.1/\>5.1).
Participant milestones
| Measure |
FKB327
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
366
|
362
|
|
Overall Study
COMPLETED
|
333
|
328
|
|
Overall Study
NOT COMPLETED
|
33
|
34
|
Reasons for withdrawal
| Measure |
FKB327
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
4
|
|
Overall Study
Lack of Efficacy
|
2
|
1
|
|
Overall Study
Adverse Event
|
13
|
9
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
11
|
16
|
|
Overall Study
Screen failure
|
0
|
1
|
|
Overall Study
Protocol deviation
|
2
|
3
|
Baseline Characteristics
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
Baseline characteristics by cohort
| Measure |
FKB327
n=366 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=362 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
Total
n=728 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
53.6 years
n=7 Participants
|
53.3 years
n=5 Participants
|
|
Age, Customized
<18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Between 18 and 65 years
|
302 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
601 Participants
n=5 Participants
|
|
Age, Customized
>65 years
|
64 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
281 Participants
n=5 Participants
|
284 Participants
n=7 Participants
|
565 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
85 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
311 Participants
n=5 Participants
|
308 Participants
n=7 Participants
|
619 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
51 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
4 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
15 participants
n=5 Participants
|
13 participants
n=7 Participants
|
28 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
39 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
56 participants
n=5 Participants
|
58 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
67 participants
n=5 Participants
|
67 participants
n=7 Participants
|
134 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Chile
|
20 participants
n=5 Participants
|
21 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
Peru
|
51 participants
n=5 Participants
|
49 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
14 participants
n=5 Participants
|
12 participants
n=7 Participants
|
26 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
57 participants
n=5 Participants
|
52 participants
n=7 Participants
|
109 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
The primary efficacy endpoint was the ACR20 response rate at Week 24. An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index \[HAQ-DI\])
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
American College of Rheumatology (ACR) 20 Response Rate
|
72.5 Percentage of participants
Interval 67.5 to 77.0
|
74.3 Percentage of participants
Interval 69.4 to 78.8
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Week 2
|
4.92 units on a scale
Standard Deviation 1.070
|
4.86 units on a scale
Standard Deviation 1.203
|
|
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Week 4
|
4.44 units on a scale
Standard Deviation 1.317
|
4.43 units on a scale
Standard Deviation 1.383
|
|
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Week 8
|
4.11 units on a scale
Standard Deviation 1.295
|
4.09 units on a scale
Standard Deviation 1.397
|
|
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Week 12
|
3.81 units on a scale
Standard Deviation 1.320
|
3.85 units on a scale
Standard Deviation 1.339
|
|
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Week 16
|
3.68 units on a scale
Standard Deviation 1.304
|
3.67 units on a scale
Standard Deviation 1.419
|
|
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Week 20
|
3.58 units on a scale
Standard Deviation 1.329
|
3.57 units on a scale
Standard Deviation 1.388
|
|
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Week 24
|
3.47 units on a scale
Standard Deviation 1.298
|
3.47 units on a scale
Standard Deviation 1.336
|
|
Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score
Baseline
|
6.05 units on a scale
Standard Deviation 0.913
|
6.06 units on a scale
Standard Deviation 0.852
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment.Patients were analysed according to the randomised treatment in the primary analysis.
An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index \[HAQ-DI\])
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
ACR20 Response Rates Over Time
Week 2
|
37.3 percentage of responders
Interval 32.3 to 42.5
|
31 percentage of responders
Interval 26.2 to 36.1
|
|
ACR20 Response Rates Over Time
Week 4
|
51 percentage of responders
Interval 45.7 to 56.3
|
52.4 percentage of responders
Interval 47.1 to 57.8
|
|
ACR20 Response Rates Over Time
Week 8
|
64.6 percentage of responders
Interval 59.4 to 69.6
|
67.7 percentage of responders
Interval 62.5 to 72.6
|
|
ACR20 Response Rates Over Time
Week 12
|
69.2 percentage of responders
Interval 64.1 to 74.0
|
72.2 percentage of responders
Interval 67.2 to 76.9
|
|
ACR20 Response Rates Over Time
Week 16
|
74.6 percentage of responders
Interval 69.7 to 79.1
|
74.9 percentage of responders
Interval 69.9 to 79.4
|
|
ACR20 Response Rates Over Time
Week 20
|
78 percentage of responders
Interval 73.2 to 82.2
|
77.8 percentage of responders
Interval 73.0 to 82.1
|
|
ACR20 Response Rates Over Time
Week 24
|
77.1 percentage of responders
Interval 72.3 to 81.5
|
79.3 percentage of responders
Interval 74.6 to 83.5
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index \[HAQ-DI\])
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
ACR50 Response Rates Over Time
Week 2
|
5 percentage of responders
Interval 3.0 to 7.7
|
8.8 percentage of responders
Interval 6.1 to 12.3
|
|
ACR50 Response Rates Over Time
Week 4
|
17.3 percentage of responders
Interval 13.5 to 21.6
|
17.8 percentage of responders
Interval 13.9 to 22.2
|
|
ACR50 Response Rates Over Time
Week 8
|
28.9 percentage of responders
Interval 24.2 to 33.9
|
30.9 percentage of responders
Interval 26.1 to 36.1
|
|
ACR50 Response Rates Over Time
Week 12
|
37.6 percentage of responders
Interval 32.5 to 42.9
|
35.1 percentage of responders
Interval 30.0 to 40.4
|
|
ACR50 Response Rates Over Time
Week 16
|
39.4 percentage of responders
Interval 34.3 to 44.8
|
44.7 percentage of responders
Interval 39.4 to 50.2
|
|
ACR50 Response Rates Over Time
Week 20
|
45.5 percentage of responders
Interval 40.2 to 50.9
|
46 percentage of responders
Interval 40.6 to 51.5
|
|
ACR50 Response Rates Over Time
Week 24
|
49 percentage of responders
Interval 43.6 to 54.4
|
49.4 percentage of responders
Interval 44.0 to 54.9
|
SECONDARY outcome
Timeframe: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. * Acute phase reactant (CRP) * Patient global assessment of disease activity * Physician global assessment of disease activity * Patient pain scale * Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index \[HAQ-DI\])
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
ACR70 Response Rates Over Time
Week 2
|
0.3 percentage of responders
Interval 0.0 to 1.5
|
2.3 percentage of responders
Interval 1.0 to 4.4
|
|
ACR70 Response Rates Over Time
Week 4
|
4.5 percentage of responders
Interval 2.6 to 7.1
|
6.9 percentage of responders
Interval 4.5 to 10.1
|
|
ACR70 Response Rates Over Time
Week 8
|
11.3 percentage of responders
Interval 8.2 to 15.1
|
10.7 percentage of responders
Interval 7.6 to 14.4
|
|
ACR70 Response Rates Over Time
Week 12
|
15.4 percentage of responders
Interval 11.8 to 19.6
|
13.2 percentage of responders
Interval 9.8 to 17.2
|
|
ACR70 Response Rates Over Time
Week 24
|
21.3 percentage of responders
Interval 17.1 to 26.1
|
25.1 percentage of responders
Interval 20.6 to 30.1
|
|
ACR70 Response Rates Over Time
Week 16
|
17.4 percentage of responders
Interval 13.6 to 21.8
|
19 percentage of responders
Interval 15.0 to 23.6
|
|
ACR70 Response Rates Over Time
Week 20
|
20.9 percentage of responders
Interval 16.7 to 25.5
|
23.6 percentage of responders
Interval 19.2 to 28.5
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Swollen Joint Count
Baseline
|
16.3 Count / Score
Standard Deviation 9.1
|
16 Count / Score
Standard Deviation 8.96
|
|
Swollen Joint Count
Week 24
|
3.8 Count / Score
Standard Deviation 6.04
|
3.5 Count / Score
Standard Deviation 5.23
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Tender Joint Count
Baseline
|
26.2 Count / Score
Standard Deviation 14.49
|
25.9 Count / Score
Standard Deviation 14.52
|
|
Tender Joint Count
Week 24
|
8.5 Count / Score
Standard Deviation 10.56
|
8.1 Count / Score
Standard Deviation 9.36
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Analysis of Serum C-Reactive Protein (CRP) Concentration
Baseline
|
25.12 mg/L
Standard Deviation 26.746
|
26.73 mg/L
Standard Deviation 28.534
|
|
Analysis of Serum C-Reactive Protein (CRP) Concentration
Week 24
|
10.98 mg/L
Standard Deviation 16.819
|
11.78 mg/L
Standard Deviation 18.528
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Patient Assessment of Disease Activity
Baseline
|
68 units on a scale
Standard Deviation 17.98
|
68.2 units on a scale
Standard Deviation 18.18
|
|
Patient Assessment of Disease Activity
Week 24
|
35.2 units on a scale
Standard Deviation 24.04
|
33.2 units on a scale
Standard Deviation 23.4
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Physician Assessment of Disease Activity
Baseline
|
68.4 units on a scale
Standard Deviation 14.58
|
66.2 units on a scale
Standard Deviation 15.48
|
|
Physician Assessment of Disease Activity
Week 24
|
21.5 units on a scale
Standard Deviation 17.29
|
21.5 units on a scale
Standard Deviation 16.97
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured ("No pain" at 0 and "Intolerable pain" at 100). Patient's assessment of pain is a value of the individual ACR core set variables.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Patient's Assessment of Pain
Baseline
|
66.8 units on a scale
Standard Deviation 18.71
|
67.7 units on a scale
Standard Deviation 18.56
|
|
Patient's Assessment of Pain
Week 24
|
34.7 units on a scale
Standard Deviation 23.86
|
33.6 units on a scale
Standard Deviation 23.86
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
Baseline
|
1.78 units on a scale
Standard Deviation 0.544
|
1.8 units on a scale
Standard Deviation 0.538
|
|
Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 24
|
1.21 units on a scale
Standard Deviation 0.696
|
1.26 units on a scale
Standard Deviation 0.719
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
DAS28-CRP Score Over Time
Baseline
|
6.05 units on a scale
Standard Deviation 0.913
|
6.06 units on a scale
Standard Deviation 0.852
|
|
DAS28-CRP Score Over Time
Week 24
|
3.47 units on a scale
Standard Deviation 1.298
|
3.47 units on a scale
Standard Deviation 1.336
|
SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: The Full Analysis Set (FAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and who had at least 1 evaluable primary efficacy measurement after their first dose of randomised treatment. Patients were analysed according to the randomised treatment in the primary analysis.
The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity.
Outcome measures
| Measure |
FKB327
n=363 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
Baseline
|
6.52 units on a scale
Standard Deviation 0.941
|
6.56 units on a scale
Standard Deviation 0.902
|
|
DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 12
|
4.24 units on a scale
Standard Deviation 1.382
|
4.24 units on a scale
Standard Deviation 1.353
|
|
DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR)
Week 24
|
3.82 units on a scale
Standard Deviation 1.384
|
3.85 units on a scale
Standard Deviation 1.371
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and last sampling dayPopulation: The Safety Analysis Set was defined as the set of patients who received at least 1 dose of randomised treatment. The Safety Analysis Set was used for all safety analyses. Patient safety data were analysed according to treatment actually received.
Blood samples for the assessment of ADA activity were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12, and 24.
Outcome measures
| Measure |
FKB327
n=366 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=362 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Percentage of Patients Developing Anti-drug Antibodies (ADAs)
Baseline (Positive)
|
4.4 percentage of patients
|
5.5 percentage of patients
|
|
Percentage of Patients Developing Anti-drug Antibodies (ADAs)
Baseline (Negative)
|
95.4 percentage of patients
|
94.2 percentage of patients
|
|
Percentage of Patients Developing Anti-drug Antibodies (ADAs)
Baseline (Missing)
|
0.3 percentage of patients
|
0.3 percentage of patients
|
|
Percentage of Patients Developing Anti-drug Antibodies (ADAs)
Last sampling day (Positive)
|
61.7 percentage of patients
|
59.1 percentage of patients
|
|
Percentage of Patients Developing Anti-drug Antibodies (ADAs)
Last sampling day (Negative)
|
38.3 percentage of patients
|
40.9 percentage of patients
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Week 2, Week 4, Week 12, Week 20, and Week 24Population: The Pharmacokinetic Analysis Set (PKAS) was defined as the set of patients who received at least 1 dose of the randomised treatment and had at least 1 serum adalimumab concentration result after receiving randomised treatment.
Blood samples for the quantification of adalimumab concentration in serum were collected at Baseline (Week 0), prior to dosing at Weeks 2, 4, 12 and 20, and Week 24. Samples were taken prior to dosing (trough samples).
Outcome measures
| Measure |
FKB327
n=364 Participants
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=358 Participants
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Trough Adalimumab Concentration
Week 2
|
2434.6 ng/mL
Interval 2321.4 to 2553.2
|
2089.1 ng/mL
Interval 1990.9 to 2192.2
|
|
Trough Adalimumab Concentration
Week 4
|
3450.6 ng/mL
Interval 3223.2 to 3694.1
|
2932.1 ng/mL
Interval 2737.0 to 3141.1
|
|
Trough Adalimumab Concentration
Week 12
|
4316.3 ng/mL
Interval 3919.6 to 4753.2
|
3851.5 ng/mL
Interval 3493.9 to 4245.7
|
|
Trough Adalimumab Concentration
Week 20
|
4369.8 ng/mL
Interval 3892.3 to 4905.9
|
3873 ng/mL
Interval 3445.9 to 4353.0
|
|
Trough Adalimumab Concentration
Week 24
|
4126 ng/mL
Interval 3645.1 to 4670.4
|
3758.2 ng/mL
Interval 3316.8 to 4258.3
|
Adverse Events
FKB327
Serious events: 15 serious events
Other events: 26 other events
Deaths: 1 deaths
Humira®
Serious events: 19 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FKB327
n=366 participants at risk
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=362 participants at risk
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Vascular disorders
Thrombophlebitis
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.55%
2/362 • Number of events 2 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Immune system disorders
Amyloidosis
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Gastrointestinal disorders
Anal fistula
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Pneumonia
|
0.82%
3/366 • Number of events 3 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Disseminated tuberculosis
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.55%
2/362 • Number of events 2 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Bronchopneumonia
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Cervicitis
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Erysipelas
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Gangrene
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Latent tuberculosis
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Osteomyelitis chronic
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/366 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.28%
1/362 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Sepsis
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
|
Infections and infestations
Urinary tract infection
|
0.27%
1/366 • Number of events 1 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
0.00%
0/362 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
Other adverse events
| Measure |
FKB327
n=366 participants at risk
Patients were administered subcutaneous (sc) FKB327 40 mg every other week (eow). The treatment period was 22 weeks.
|
Humira®
n=362 participants at risk
Patients were administered subcutaneous (sc) Humira 40 mg every other week (eow). The treatment period was 22 weeks.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.1%
26/366 • Number of events 26 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
8.0%
29/362 • Number of events 29 • Patients were carefully monitored for adverse events from signing of informed consent until Week 24 (for patients who entered the open-label extension), Week 26 (for patients who did not enter the open-label extension), or the Early Termination visit. In total this covered a period of approximately 1 year and 6 months.
Serious adverse events were followed until resolution, the Investigator confirmed the event was unlikely to resolve or the patient was recorded as lost to follow-up.
|
Additional Information
Clinical Trial Information
Fujifilm Kyowa Kirin Biologics Co., Ltd., EU Branch
Phone: +44 1896 668 173
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator and Sponsor will discuss the preparation of a manuscript for publication in a peer reviewed journal or an abstract for presentation. Either party may undertake the task but both must agree to the strategy before work is started. Each party will allow the other 30 days to comment before any results are submitted for publication or presentation. Authorship should reflect work done by the Investigators and Sponsor, in accordance with recognised principles of scientific collaboration.
- Publication restrictions are in place
Restriction type: OTHER