Trial Outcomes & Findings for A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate (NCT NCT00965757)
NCT ID: NCT00965757
Last Updated: 2021-12-17
Results Overview
ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
253 participants
Primary outcome timeframe
Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)
Results posted on
2021-12-17
Participant Flow
Participant milestones
| Measure |
T-614 (Double-blind, 1-28 Weeks)
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
T-614 (Extension, 29-52 Weeks)
T-614 was administered in combination with methotrexate. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo/T-614 (Extension, 29-52 Weeks)
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|---|
|
Double-blind Phase
STARTED
|
165
|
88
|
0
|
0
|
|
Double-blind Phase
COMPLETED
|
148
|
70
|
0
|
0
|
|
Double-blind Phase
NOT COMPLETED
|
17
|
18
|
0
|
0
|
|
Extension Phase
STARTED
|
0
|
0
|
165
|
88
|
|
Extension Phase
COMPLETED
|
0
|
0
|
132
|
64
|
|
Extension Phase
NOT COMPLETED
|
0
|
0
|
33
|
24
|
Reasons for withdrawal
| Measure |
T-614 (Double-blind, 1-28 Weeks)
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
T-614 (Extension, 29-52 Weeks)
T-614 was administered in combination with methotrexate. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo/T-614 (Extension, 29-52 Weeks)
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|---|
|
Double-blind Phase
Progression of concomitant disease
|
1
|
2
|
0
|
0
|
|
Double-blind Phase
Adverse drug reaction
|
2
|
1
|
0
|
0
|
|
Double-blind Phase
Abnormal Laboratory Value
|
2
|
0
|
0
|
0
|
|
Double-blind Phase
Lack of Efficacy
|
7
|
11
|
0
|
0
|
|
Double-blind Phase
Drug Refusal Due to Adverse Event
|
2
|
0
|
0
|
0
|
|
Double-blind Phase
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Double-blind Phase
Ineligible after Taking Study Drug
|
2
|
3
|
0
|
0
|
|
Double-blind Phase
Other
|
1
|
0
|
0
|
0
|
|
Extension Phase
Progression of concomitant disease
|
0
|
0
|
4
|
2
|
|
Extension Phase
Adverse drug reaction
|
0
|
0
|
6
|
3
|
|
Extension Phase
Abnormal Laboratory Value
|
0
|
0
|
6
|
1
|
|
Extension Phase
Lack of Efficacy
|
0
|
0
|
8
|
12
|
|
Extension Phase
Drug Refusal Due to Adverse Event
|
0
|
0
|
4
|
0
|
|
Extension Phase
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Extension Phase
Ineligible after Taking Study Drug
|
0
|
0
|
3
|
3
|
|
Extension Phase
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Extension Phase
Other
|
0
|
0
|
2
|
1
|
Baseline Characteristics
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Baseline characteristics by cohort
| Measure |
T-614 (Double-blind, 1-28 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Total
n=252 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.8 Years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
53.5 Years
STANDARD_DEVIATION 10 • n=7 Participants
|
54.3 Years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
204 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Duration of Rheumatoid Arthritis
|
53.8 Months
STANDARD_DEVIATION 35 • n=5 Participants
|
50.3 Months
STANDARD_DEVIATION 34 • n=7 Participants
|
52.6 Months
STANDARD_DEVIATION 34.6 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24 Last Observation Carried Forward (LOCF) (for T-614 arm and placebo arm) and Week 52 LOCF (for T-614 arm and placebo/T614 arm)Population: Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)
ACR20 response is defined as at least a 20% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders
Week 24 LOCF
|
69.5 Percentage of Participants
Interval 61.9 to 76.5
|
30.7 Percentage of Participants
Interval 21.3 to 41.4
|
NA Percentage of Participants
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders
Week 52 LOCF
|
71.3 Percentage of Participants
Interval 63.8 to 78.1
|
NA Percentage of Participants
Week 52 is not applicable as this arm completed at week 28
|
72.1 Percentage of Participants
Interval 59.9 to 82.3
|
SECONDARY outcome
Timeframe: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)Population: FAS (Double-blind), Efficacy Analysis Set (Extension)
Assessment of individual ACR core components like Tender Joint Counts (TJC) and Swollen Joint Counts (SJC)
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Baseline: TJC
|
12.5 joint counts
Standard Deviation 6.5
|
13.3 joint counts
Standard Deviation 8.1
|
13.8 joint counts
Standard Deviation 8.5
|
|
Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Change from baseline at week 24 LOCF: TJC
|
-7.4 joint counts
Standard Deviation 6
|
-4.6 joint counts
Standard Deviation 7.8
|
NA joint counts
Standard Deviation NA
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Change from baseline at week 52 LOCF: TJC
|
-8.4 joint counts
Standard Deviation 6.1
|
NA joint counts
Standard Deviation NA
Week 52 is not applicable as this arm completed at week 28
|
-9.9 joint counts
Standard Deviation 7.6
|
|
Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Baseline: SJC
|
11.5 joint counts
Standard Deviation 6.3
|
11.1 joint counts
Standard Deviation 5.7
|
10.9 joint counts
Standard Deviation 5.8
|
|
Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Change from baseline at week 24 LOCF: SJC
|
-6.5 joint counts
Standard Deviation 5.9
|
-2.9 joint counts
Standard Deviation 6.7
|
NA joint counts
Standard Deviation NA
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Change From Baseline in Tender Joint Counts and Swollen Joint Counts
Change from baseline at week 52 LOCF: SJC
|
-7.1 joint counts
Standard Deviation 6.8
|
NA joint counts
Standard Deviation NA
Week 52 is not applicable as this arm completed at week 28
|
-6.3 joint counts
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)Population: FAS (Double-blind), Efficacy Analysis Set (Extension)
Patient's assessment of pain (PAP), patient's global assessment of disease activity (PtGADA) and physician's global assessment of disease activity (PyGADA) each was assessed on a visual analog scale ranging from 0-100 mm, with higher scores indicating severe disease.
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Change From Baseline in PAP, PtGADA and PyGADA
Baseline PAP
|
47.5 mm
Standard Deviation 22.2
|
46.4 mm
Standard Deviation 23.1
|
44.8 mm
Standard Deviation 22.4
|
|
Change From Baseline in PAP, PtGADA and PyGADA
Change from baseline in PAP: week 24 LOCF
|
-22 mm
Standard Deviation 23.8
|
-2.5 mm
Standard Deviation 27
|
NA mm
Standard Deviation NA
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Change From Baseline in PAP, PtGADA and PyGADA
Change from baseline in PAP: week 52 LOCF
|
-24 mm
Standard Deviation 24.1
|
NA mm
Standard Deviation NA
Week 52 is not applicable as this arm completed at week 28
|
-21.4 mm
Standard Deviation 26.6
|
|
Change From Baseline in PAP, PtGADA and PyGADA
Baseline PtGADA
|
47.7 mm
Standard Deviation 24.3
|
50.1 mm
Standard Deviation 23.5
|
48.4 mm
Standard Deviation 23.6
|
|
Change From Baseline in PAP, PtGADA and PyGADA
Change from baseline in PtGADA: week 24 LOCF
|
-21.2 mm
Standard Deviation 26.4
|
-5 mm
Standard Deviation 27.1
|
NA mm
Standard Deviation NA
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Change From Baseline in PAP, PtGADA and PyGADA
Change from baseline in PtGADA: week 52 LOCF
|
-24.3 mm
Standard Deviation 26
|
NA mm
Standard Deviation NA
Week 52 is not applicable as this arm completed at week 28
|
-23.1 mm
Standard Deviation 27.7
|
|
Change From Baseline in PAP, PtGADA and PyGADA
Baseline PyGADA
|
52.6 mm
Standard Deviation 18.3
|
53.2 mm
Standard Deviation 19
|
52.1 mm
Standard Deviation 17.9
|
|
Change From Baseline in PAP, PtGADA and PyGADA
Change from baseline in PyGADA: week 24 LOCF
|
-27.1 mm
Standard Deviation 19.3
|
-10.4 mm
Standard Deviation 26.6
|
NA mm
Standard Deviation NA
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Change From Baseline in PAP, PtGADA and PyGADA
Change from baseline in PyGADA: week 52 LOCF
|
-29.1 mm
Standard Deviation 22.4
|
NA mm
Standard Deviation NA
Week 52 is not applicable as this arm completed at week 28
|
-29.9 mm
Standard Deviation 24.4
|
SECONDARY outcome
Timeframe: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)Population: FAS (Double-blind), Efficacy Analysis Set (Extension)
HAQ-DI was a participant assessed measure of health assessment, measured on a single scale ranging from 0 (no difficulty) to 3 (unable to do), with higher scores indicating severe disease.
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Baseline
|
0.8178 score on scale
Standard Deviation 0.5525
|
0.7344 score on scale
Standard Deviation 0.5117
|
0.7188 score on scale
Standard Deviation 0.5274
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 24 LOCF
|
-0.3544 score on scale
Standard Deviation 0.4492
|
0.0256 score on scale
Standard Deviation 0.549
|
NA score on scale
Standard Deviation NA
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI)
Week 52 LOCF
|
-0.4093 score on scale
Standard Deviation 0.4566
|
NA score on scale
Standard Deviation NA
Week 52 is not applicable as this arm completed at week 28
|
-0.2904 score on scale
Standard Deviation 0.4669
|
SECONDARY outcome
Timeframe: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)Population: FAS (Double-blind), Efficacy Analysis Set (Extension)
Assessment of individual ACR core components i.e. CRP
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Change From Baseline in C-reactive Protein (CRP)
Baseline
|
1.843 mg/dl
Standard Deviation 1.943
|
1.705 mg/dl
Standard Deviation 1.583
|
1.714 mg/dl
Standard Deviation 1.611
|
|
Change From Baseline in C-reactive Protein (CRP)
Week 24 LOCF
|
-0.528 mg/dl
Standard Deviation 2.067
|
0.47 mg/dl
Standard Deviation 2.028
|
NA mg/dl
Standard Deviation NA
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Change From Baseline in C-reactive Protein (CRP)
Week 52 LOCF
|
-0.609 mg/dl
Standard Deviation 1.841
|
NA mg/dl
Standard Deviation NA
Week 52 is not applicable as this arm completed at week 28
|
-0.581 mg/dl
Standard Deviation 1.866
|
SECONDARY outcome
Timeframe: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)Population: FAS (Double-blind), Efficacy Analysis Set (Extension)
Assessment of individual ACR core components i.e. ESR
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Baseline
|
45.6 mm/hr
Standard Deviation 21
|
41.8 mm/hr
Standard Deviation 22.5
|
40.1 mm/hr
Standard Deviation 23.2
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 24 LOCF
|
-9.3 mm/hr
Standard Deviation 20.8
|
2.6 mm/hr
Standard Deviation 19.7
|
NA mm/hr
Standard Deviation NA
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Week 52 LOCF
|
-9.4 mm/hr
Standard Deviation 21.3
|
NA mm/hr
Standard Deviation NA
Week 52 is not applicable as this arm completed at week 28
|
-8.8 mm/hr
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)Population: FAS (Double-blind), Efficacy Analysis Set (Extension)
The DAS28 is a composite score derived from 4 of these measures i.e count of 28 swollen joints, 28 tender joints, measure erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) and to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). DAS28 is assessed as score on scale from 0 to 10 indicating current rheumatoid arthritis (RA) disease activity (0= low disease activity and 10 = high disease activity).
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)
Low Disease Activity: week 24 LOCF
|
78 participants
|
18 participants
|
NA participants
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)
Remission: week 24 LOCF
|
45 participants
|
8 participants
|
NA participants
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)
Remission: week 52 LOCF
|
56 participants
|
NA participants
Week 52 is not applicable as this arm completed at week 28
|
23 participants
|
|
Disease Activity Score in 28 Joints (DAS28): The Rates of Remission (DAS28-CRP Less Than 2.6), and Low Disease Activity (DAS28-CRP Less Than 3.2)
Low Disease Activity: week 52 LOCF
|
88 participants
|
NA participants
Week 52 is not applicable as this arm completed at week 28
|
38 participants
|
SECONDARY outcome
Timeframe: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)Population: Full Analysis Set (Double-blind), Efficacy Analysis Set (Extension)
ACR50 response is defined as at least a 50% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Percentage of ACR 50 Criteria Responders
Week 24 LOCF
|
38.4 Percentage of Participants
Interval 30.9 to 46.3
|
15.9 Percentage of Participants
Interval 9.0 to 25.2
|
NA Percentage of Participants
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Percentage of ACR 50 Criteria Responders
Week 52 LOCF
|
49.4 Percentage of Participants
Interval 41.5 to 57.3
|
NA Percentage of Participants
Week 52 is not applicable as this arm completed at week 28
|
45.6 Percentage of Participants
Interval 33.5 to 58.1
|
SECONDARY outcome
Timeframe: Week 24 LOCF (for T-614 arm and placebo arm) and Week 52 LOCF (for T614 arm and placebo/T614 arm)Population: FAS (Double-blind), Efficacy Analysis Set (Extension)
ACR70 response is defined as at least a 70% improvement in tender joint count and swollen joint count, and in three of five of the following measures: patient pain intensity assessment, patient global assessment, physician global assessment, Health assessment questionnaire disability index (HAQ-DI), and an acute phase reactant \[erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP)\].
Outcome measures
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 Participants
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 Participants
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 Participants
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Percentage of ACR 70 Criteria Responders
Week 24 LOCF
|
17.1 Percentage of Participants
Interval 11.7 to 23.7
|
5.7 Percentage of Participants
Interval 1.9 to 12.8
|
NA Percentage of Participants
Week 24 is not applicable as this arm starts from week 29 to week 52
|
|
Percentage of ACR 70 Criteria Responders
Week 52 LOCF
|
23.8 Percentage of Participants
Interval 17.5 to 31.0
|
NA Percentage of Participants
Week 52 is not applicable as this arm completed at week 28
|
22.1 Percentage of Participants
Interval 12.9 to 33.8
|
Adverse Events
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
Serious events: 2 serious events
Other events: 135 other events
Deaths: 0 deaths
Placebo (Double-blind, 1-28 Weeks)
Serious events: 2 serious events
Other events: 43 other events
Deaths: 0 deaths
Placebo/T-614 (Extension, 29-52 Weeks)
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 participants at risk
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 participants at risk
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 participants at risk
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.61%
1/164 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/68 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.61%
1/164 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/68 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fallopian tube cancer
|
0.00%
0/164 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
1.1%
1/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/68 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/164 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
1.1%
1/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/68 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
Other adverse events
| Measure |
T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)
n=164 participants at risk
T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
|
Placebo (Double-blind, 1-28 Weeks)
n=88 participants at risk
Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
|
Placebo/T-614 (Extension, 29-52 Weeks)
n=68 participants at risk
Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
31.7%
52/164 • Number of events 71 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
15.9%
14/88 • Number of events 18 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
22.1%
15/68 • Number of events 17 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Infections and infestations
Pharyngitis
|
6.1%
10/164 • Number of events 14 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
6.8%
6/88 • Number of events 6 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/68 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
12.2%
20/164 • Number of events 25 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
2.3%
2/88 • Number of events 3 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
5.9%
4/68 • Number of events 4 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Gastrointestinal disorders
Stomatitis
|
11.0%
18/164 • Number of events 26 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
2.3%
2/88 • Number of events 2 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
5.9%
4/68 • Number of events 4 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Investigations
Lymphocyte count decreased
|
17.7%
29/164 • Number of events 48 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
9.1%
8/88 • Number of events 13 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
10.3%
7/68 • Number of events 12 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Investigations
Aspartate aminotransferase increased
|
16.5%
27/164 • Number of events 44 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
5.7%
5/88 • Number of events 5 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
4.4%
3/68 • Number of events 4 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Investigations
Alanine aminotransferase increased
|
14.6%
24/164 • Number of events 31 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
8.0%
7/88 • Number of events 7 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
7.4%
5/68 • Number of events 6 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Investigations
Beta 2 microglobulin increased
|
9.1%
15/164 • Number of events 17 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
2.3%
2/88 • Number of events 2 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
7.4%
5/68 • Number of events 5 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Investigations
Beta 2 microglobulin urine increased
|
9.1%
15/164 • Number of events 20 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
1.1%
1/88 • Number of events 1 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
5.9%
4/68 • Number of events 7 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Investigations
Blood iron decreased
|
26.2%
43/164 • Number of events 71 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
18.2%
16/88 • Number of events 26 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
13.2%
9/68 • Number of events 10 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Infections and infestations
Bronchitis
|
4.9%
8/164 • Number of events 10 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
7.4%
5/68 • Number of events 5 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
11/164 • Number of events 13 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
2.9%
2/68 • Number of events 2 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
4.9%
8/164 • Number of events 9 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
5.9%
4/68 • Number of events 5 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
9/164 • Number of events 10 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
2.9%
2/68 • Number of events 2 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
11/164 • Number of events 11 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
1.5%
1/68 • Number of events 1 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.1%
15/164 • Number of events 19 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
2.9%
2/68 • Number of events 3 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
|
Investigations
Blood urea increased
|
7.9%
13/164 • Number of events 16 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
0.00%
0/88 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
4.4%
3/68 • Number of events 3 • Up to 1 - 52 weeks for T614 (double-blind and extension) arm, up to 1 - 24 weeks for placebo (double-blind) arm and Up to 29 - 52 Weeks for placebo/T614 (extension) arm.
Treatment emergent adverse events are presented in this section.
|
Additional Information
Kota Nagai
Eisai Co., Ltd.
Phone: +81-3-3817-5238
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER