Trial Outcomes & Findings for A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy (NCT NCT02006706)
NCT ID: NCT02006706
Last Updated: 2017-08-21
Results Overview
DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale \[VAS\]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.
COMPLETED
PHASE3
15 participants
Baseline, Week 24
2017-08-21
Participant Flow
Participant milestones
| Measure |
Rituximab/Methylprednisolone/Methotrexate (MTX)
Participants received rituximab 1000 milligrams (mg), intravaneously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
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|---|---|
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Overall Study
STARTED
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15
|
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Overall Study
COMPLETED
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14
|
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Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Rituximab/Methylprednisolone/Methotrexate (MTX)
Participants received rituximab 1000 milligrams (mg), intravaneously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
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|---|---|
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Overall Study
Lost to Follow-up
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1
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Baseline Characteristics
A Study of MabThera/Rituxan (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis and Inadequate Response to DMARD Therapy
Baseline characteristics by cohort
| Measure |
Rituximab/Methylprednisolone/MTX
n=14 Participants
Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
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|---|---|
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Age, Continuous
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52.29 years
STANDARD_DEVIATION 11.89 • n=5 Participants
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
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13 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
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5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
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Region of Enrollment
Serbia
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14 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24Population: Per Protocol (PP) Population: included all participants who received at least one dose of study drug and who did not have any protocol violations.
DAS28 was calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant-rated arthritis activity assessment using visual analog scale \[VAS\]) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤)3.2 equals (=) low disease activity, DAS28 greater than (\>)3.2 to 5.1 = moderate to high disease activity.
Outcome measures
| Measure |
Rituximab/Methylprednisolone/MTX
n=14 Participants
Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
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|---|---|
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Change From Baseline Disease Activity Score Based on 28-Joint Count (DAS28) at Week 24
|
2.98 score on a scale
Standard Deviation 1.80
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: PP 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/Methylprednisolone/MTX
n=14 Participants
Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
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|---|---|
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Health Assessment Questionnaire-Disability Index (HAQ-DI)
Baseline
|
1.91 score on a scale
Standard Deviation 0.687
|
|
Health Assessment Questionnaire-Disability Index (HAQ-DI)
Week 24
|
1.05 score on a scale
Standard Deviation 0.960
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Adverse Events
Rituximab/Methylprednisolone/MTX
Serious adverse events
| Measure |
Rituximab/Methylprednisolone/MTX
n=14 participants at risk
Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
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|---|---|
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Cardiac disorders
Infarctus myocardii
|
7.1%
1/14 • Adverse events (AEs) were reported starting with the first dose of study drug through the end of the study (24 weeks total).
|
|
Gastrointestinal disorders
Enterocolitis acuta
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7.1%
1/14 • Adverse events (AEs) were reported starting with the first dose of study drug through the end of the study (24 weeks total).
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Other adverse events
Adverse event data not reported
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 the 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