Trial Outcomes & Findings for A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies. (NCT NCT00462345)
NCT ID: NCT00462345
Last Updated: 2014-11-04
Results Overview
ACR20 response: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ-DI\]); and either C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
Week 24
Results posted on
2014-11-04
Participant Flow
Participant milestones
| Measure |
Rituximab, Methotrexate
Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate at a stable dose of greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Overall Study
STARTED
|
40
|
|
Overall Study
Completed First Course
|
38
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Rituximab, Methotrexate
Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate at a stable dose of greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Overall Study
Withdrawal by Subject
|
2
|
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Overall Study
Did not complete second course
|
1
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Baseline Characteristics
A Study of MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNF Therapies.
Baseline characteristics by cohort
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Age, Continuous
|
49.9 years
STANDARD_DEVIATION 11.4 • n=5 Participants
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|
Sex: Female, Male
Female
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34 Participants
n=5 Participants
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Sex: Female, Male
Male
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6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: ITT population
ACR20 response: ≥20% improvement in tender joint count; ≥20% improvement in swollen joint count; and ≥20% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; Patient Global Assessment of Disease Activity (PtGA); Physician Global Assessment of Disease Activity (PGA); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ-DI\]); and either C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Percentage of Participants With An American College of Rheumatology 20 Percent (%) Improvement Criteria (ACR20) Response at Week 24
|
47.5 percentage of participants
Interval 31.5 to 63.9
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SECONDARY outcome
Timeframe: Week 24Population: ITT population
ACR50 response: ≥50% improvement in tender joint count; ≥50% improvement in swollen joint count; and ≥50% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Percentage of Participants With An American College of Rheumatology 50% Improvement Criteria (ACR50) Response at Week 24
|
7.5 percentage of participants
Interval 1.6 to 20.4
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SECONDARY outcome
Timeframe: Week 24Population: ITT population
ACR70 response: ≥70% improvement in tender joint count; ≥70% improvement in swollen joint count; and ≥70% improvement in at least 3 of 5 remaining ACR core measures: Patient Assessment of Pain; PtGA; PGA; self-assessed disability (HAQ-DI); and either CRP or ESR.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Percentage of Participants With An American College of Rheumatology 70% Improvement Criteria (ACR70) Response at Week 24
|
5.0 percentage of participants
Interval 0.6 to 16.9
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SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population
DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (millimeters per hour \[mm/hr\]) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Disease Activity Score Based on 28-Joint Count (DAS-28)
Week 0
|
6.76 scores on a scale
Standard Deviation 1.02
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Disease Activity Score Based on 28-Joint Count (DAS-28)
Week 24
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5.31 scores on a scale
Standard Deviation 1.16
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Disease Activity Score Based on 28-Joint Count (DAS-28)
Change at Week 24
|
-1.45 scores on a scale
Standard Deviation 0.94
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: ITT population
DAS28 was calculated from the number of swollen joints and tender joints using the 28 joints count, the ESR (mm/hr) and PtGA of disease activity with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Percentage of Participants With Change in DAS-28 From BL to Week 24 of ≥1.2
|
60.0 percentage of participants
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SECONDARY outcome
Timeframe: Week 24Population: ITT population
The percentage of participants categorized as good, moderate, or nonresponders according to the EULAR response criteria at Week 24. Participants were categorized as good responders if the intensity of their symptoms was in the "low disease activity (DAS28 less than \[\<\]3.2)" category after treatment, and their symptoms significantly decreased to \>1.2. Participants were categorized as moderate responders if the intensity of their symptoms was in the "moderate or high disease activity (DAS28 \>3.2)" category after treatment, and the symptoms significantly decreased to \>1.2; or if the intensity of their symptoms was in the "low or moderate disease activity (DAS28 \<5.1)" category, and the DAS28 score changed more than 0.6 or 1.2 or less. Participants were categorized as non-responders if they did not fall into the good or moderate categories.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24
Good responders
|
5.0 percentage of participants
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Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24
Moderate responders
|
65.0 percentage of participants
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Percentage of Participants With DAS Response by European League Against Rheumatism (EULAR) Category at Week 24
Nonresponders
|
30.0 percentage of participants
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SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population
Number of swollen joints was determined by examination of 66 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit as swollen or not swollen.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Swollen Join Count (SJC)
Week 0
|
16.3 swollen joints
Standard Deviation 8.4
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|
Swollen Join Count (SJC)
Change at Week 24
|
-8.9 swollen joints
Standard Deviation 6.2
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Swollen Join Count (SJC)
Change at Week 48
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-11.6 swollen joints
Standard Deviation 7.2
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SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population
Number of tender joints was determined by examination of 68 joints (as assessed through pressing and palpating during the physical examination) and identifying when swelling was present. The number of tender joints was recorded on the joint assessment form at each visit as either tender or not tender.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Tender Joint Count (TJC)
Week 0
|
21.9 tender joints
Standard Deviation 14.0
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Tender Joint Count (TJC)
Change at Week 24
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-9.0 tender joints
Standard Deviation 9.3
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Tender Joint Count (TJC)
Change at Week 48
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-13.9 tender joints
Standard Deviation 11.1
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SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population
The mean score of the symptoms of rheumatoid arthritis (RA) at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100 mm horizontal VAS, where the left endpoint indicated "No disease activity" (no symptom, or no symptom of RA), and the right endpoint indicated "Maximum disease activity" (maximum RA activity). A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Patient Global Assessment of Disease Activity (VAS)
Week 0
|
72.6 mm
Standard Deviation 21.6
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|
Patient Global Assessment of Disease Activity (VAS)
Change at Week 24
|
-20.5 mm
Standard Deviation 25.8
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|
Patient Global Assessment of Disease Activity (VAS)
Change at Week 48
|
-31.8 mm
Standard Deviation 26.9
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SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population
The mean score of the symptoms of RA at Week 0 and the change from Week 0 (baseline) to Weeks 24 and 48 as assessed by investigators using a 100-mm horizontal VAS, where the left endpoint indicated "No disease activity" (no symptom, or no symptom of RA), and the right endpoint indicated "Maximum disease activity" (maximum RA activity). A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Physician Global Assessment of Disease Activity (VAS)
Week 0
|
72.8 mm
Standard Deviation 13.4
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|
Physician Global Assessment of Disease Activity (VAS)
Change at Week 24
|
-30.4 mm
Standard Deviation 24.1
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Physician Global Assessment of Disease Activity (VAS)
Change at Week 48
|
-42.1 mm
Standard Deviation 23.0
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SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population
The mean score of pain at Week 0 (baseline) and the change from Week 0 to Weeks 24 and 48 as assessed by participants using a 100-mm horizontal VAS, where the left endpoint indicated "No pain," and the right endpoint indicated "Unbearable pain." A negative change indicated improvement.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Patient Assessment of Pain (VAS)
Week 0
|
69.3 mm
Standard Deviation 20.7
|
|
Patient Assessment of Pain (VAS)
Change at Week 24
|
-16.8 mm
Standard Deviation 26.1
|
|
Patient Assessment of Pain (VAS)
Change at Week 48
|
-28.2 mm
Standard Deviation 26.8
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population
The mean level of CRP in milligrams per liter (mg/L), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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C-reactive Protein (CRP) Level
Week 0
|
3.80 mg/L
Standard Deviation 4.32
|
|
C-reactive Protein (CRP) Level
Change at Week 24
|
-1.54 mg/L
Standard Deviation 3.85
|
|
C-reactive Protein (CRP) Level
Change at Week 48
|
-2.23 mg/L
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population
The mean level of ESR (in mm/hr), an acute phase reactant, at Week 0 and the change from Week 0 to Weeks 24 and 48.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Erythrocyte Sedimentation Rate (ESR)
Week 0
|
77.2 mm/hr
Standard Deviation 28.6
|
|
Erythrocyte Sedimentation Rate (ESR)
Change at Week 24
|
-23.4 mm/hr
Standard Deviation 27.1
|
|
Erythrocyte Sedimentation Rate (ESR)
Change at Week 48
|
-36.1 mm/hr
Standard Deviation 26.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 24 and 48Population: ITT population
HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=40 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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HAQ-DI Score
Week 0
|
1.66 scores on a scale
Standard Deviation 0.70
|
|
HAQ-DI Score
Change at Week 24
|
-0.34 scores on a scale
Standard Deviation 0.58
|
|
HAQ-DI Score
Change at Week 48
|
-0.53 scores on a scale
Standard Deviation 0.64
|
SECONDARY outcome
Timeframe: Screening, Weeks 24 and 48Population: ITT population; n (number) = number of participants assessed for the specified parameter at a given visit.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Outcome measures
| Measure |
Rituximab, Methotrexate
n=39 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
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Physical Function as Assessed by Short Form 36 (SF-36)
Screening, Physical functioning (n=39)
|
27.7 scores on a scale
Standard Deviation 17.2
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Screening, Role-physical (n=39)
|
26.6 scores on a scale
Standard Deviation 21.5
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Screening, Bodily pain (n=39)
|
29.2 scores on a scale
Standard Deviation 17.5
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Screening, General health (n=39)
|
31.7 scores on a scale
Standard Deviation 16.2
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Week 24, Physical functioning (n=39)
|
35.8 scores on a scale
Standard Deviation 22.5
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Week 24, Role-physical (n=39)
|
41.5 scores on a scale
Standard Deviation 23.1
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Week 24, Bodily pain (n=39)
|
44.7 scores on a scale
Standard Deviation 19.7
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Week 24, General health (n=39)
|
38.1 scores on a scale
Standard Deviation 17.1
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Week 48, Physical functioning (n=39)
|
43.4 scores on a scale
Standard Deviation 26.7
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Week 48, Role-physical (n=38)
|
49.3 scores on a scale
Standard Deviation 29.0
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Week 48, Bodily pain (n=38)
|
50.9 scores on a scale
Standard Deviation 22.7
|
|
Physical Function as Assessed by Short Form 36 (SF-36)
Week 48, General health (n=38)
|
44.9 scores on a scale
Standard Deviation 22.7
|
SECONDARY outcome
Timeframe: Screening, Weeks 24 and 48Population: ITT population; n=number of participants assessed for the specified parameter at a given visit.
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
Outcome measures
| Measure |
Rituximab, Methotrexate
n=39 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
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|---|---|
|
SF-36 Mental Component Scores
Screening, Vitality (n=38)
|
30.3 scores on a scale
Standard Deviation 18.6
|
|
SF-36 Mental Component Scores
Screening, Social functioning (n=39)
|
41.7 scores on a scale
Standard Deviation 26.8
|
|
SF-36 Mental Component Scores
Screening, Role-emotional (n=39)
|
36.8 scores on a scale
Standard Deviation 25.3
|
|
SF-36 Mental Component Scores
Screening, Mental health (n=38)
|
52.9 scores on a scale
Standard Deviation 19.5
|
|
SF-36 Mental Component Scores
Week 24, Vitality (n=39)
|
35.7 scores on a scale
Standard Deviation 21.2
|
|
SF-36 Mental Component Scores
Week 24, Social functioning (n=39)
|
55.5 scores on a scale
Standard Deviation 25.6
|
|
SF-36 Mental Component Scores
Week 24, Role-emotional (n=39)
|
53.9 scores on a scale
Standard Deviation 27.6
|
|
SF-36 Mental Component Scores
Week 24, Mental health (n=39)
|
56.0 scores on a scale
Standard Deviation 21.4
|
|
SF-36 Mental Component Scores
Week 48, Vitality (n=38)
|
44.2 scores on a scale
Standard Deviation 26.6
|
|
SF-36 Mental Component Scores
Week 48, Social functioning (n=38)
|
63.2 scores on a scale
Standard Deviation 26.0
|
|
SF-36 Mental Component Scores
Week 48, Role-emotional (n=38)
|
55.5 scores on a scale
Standard Deviation 31.9
|
|
SF-36 Mental Component Scores
Week 48, Mental health (n=38)
|
60.7 scores on a scale
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: Screening and Weeks 24 and 48Population: ITT population
Posterior-anterior (PA) radiograph of each hand and anterior-posterior (AP) radiograph of each foot were taken separately and assessed according to Genant's method as modified from Sharp's method. The Sharp-Genant score=total of the erosion score and the joint space narrowing (JSN) score of all the hands and feet. Erosion Score: 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. JSN Score:13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total erosion score in hands=100 and in feet=42; maximum scores for JSN in the hands=100 and in feet=48. Maximum modified Sharp score achievable is 290. A lower number change from Baseline indicated a better score. Change in scores was calculated as change=final score minus initial score.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=39 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
|
|---|---|
|
Modified Total Sharp-Genant Score (mTSS)
Screening
|
79.5 scores on a scale
Standard Deviation 48.5
|
|
Modified Total Sharp-Genant Score (mTSS)
Change at Week 24
|
0.26 scores on a scale
Standard Deviation 0.55
|
|
Modified Total Sharp-Genant Score (mTSS)
Change at Week 48
|
0.64 scores on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Screening, Weeks 24 and 48Population: ITT population
Erosion Score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=Normal to 3.5=very severe erosion. Maximum total erosion score in the hands was 100 and in the feet was 42, for a maximum overall score of 142. Total erosion score was for both hands and feet.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=39 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
|
|---|---|
|
Modified Sharp Radiographic Erosion Score (ES)
Screening
|
25.2 scores on a scale
Standard Deviation 25.1
|
|
Modified Sharp Radiographic Erosion Score (ES)
Change at Week 24
|
0.18 scores on a scale
Standard Deviation 0.42
|
|
Modified Sharp Radiographic Erosion Score (ES)
Change at Week 48
|
0.49 scores on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Screening, Weeks 24 and 48Population: ITT population. 39 participants were analyzed for this outcome measure.
JSN Score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=Normal to 4.0=definite ankylosis (stiffness or fixation of a joint). Maximum total scores for JSN in the hands was 100 and in the feet was 48, for a maximum overall score of 148. Total JSN was for both hands and feet.
Outcome measures
| Measure |
Rituximab, Methotrexate
n=39 Participants
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
|
|---|---|
|
Modified Sharp Radiographic Joint Space Narrowing Score (JSN)
Screening
|
54.3 scores on a scale
Standard Deviation 27.6
|
|
Modified Sharp Radiographic Joint Space Narrowing Score (JSN)
Change at Week 24
|
0.08 scores on a scale
Standard Deviation 0.24
|
|
Modified Sharp Radiographic Joint Space Narrowing Score (JSN)
Change at Week 48
|
0.15 scores on a scale
Standard Deviation 0.51
|
Adverse Events
Rituximab, Methotrexate
Serious events: 6 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab, Methotrexate
n=40 participants at risk
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
|
|---|---|
|
Gastrointestinal disorders
Appendicitis
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Arthritis bacterial
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Infection
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Scrub typhus
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Concussion
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Surgical and medical procedures
Knee arthroplasty
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
Other adverse events
| Measure |
Rituximab, Methotrexate
n=40 participants at risk
Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
30.0%
12/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Onychomycosis
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Appendicitis
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Arthritis bacterial
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Fungal infection
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Infection
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Infections and infestations
Scrub typhus
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.5%
5/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
6/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Musculoskeletal and connective tissue disorders
Urticaria
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Feeling hot
|
10.0%
4/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Chest discomfort
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Face oedema
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Pyrexia
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Chest pain
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Fatigue
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
General disorders
Irritability
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
10.0%
4/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Constipation
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Gingival pain
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Headache
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Dizziness
|
7.5%
3/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Amnesia
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Disturbance in attention
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Nervous system disorders
Somnolence
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Concussion
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Neck injury
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Breast mass
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Galactorrhoea
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Reproductive system and breast disorders
Prostatitis
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Iridocyclitis
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Keratitis
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Eye disorders
Visual acuity reduced
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Blood pressure decreased
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Investigations
Weight decreased
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Psychiatric disorders
Insomnia
|
5.0%
2/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Renal and urinary disorders
Dysuria
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Surgical and medical procedures
Knee arthroplasty
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
|
Vascular disorders
Vasculitis
|
2.5%
1/40 • Adverse events (AEs) were reported from Screening up through Week 48 or Withdrawal Visit.
All enrolled participants who received study treatment were included in the safety analysis. The study did not include a separate analysis of nonserious AEs, therefore AEs presented in this record include all AEs reported during the study, not just nonserious events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER