A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: rituximab [MabThera/Rituxan]; Drug: methotrexate

• Registration Number: NCT00934648
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who have had an inadequate response or were intolerant to treatment with methotrexate. Eligible patients will receive MabThera (1000mg by intravenous infusion) on days 1 and 15, and background methotrexate (oral or subcutaneous dose of 10-25mg weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2009-07-06
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-08
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2014-05-07
• Status Verified: 2014-06
• Results First Submitted QC: 2014-06-09
• Last Update Submitted: 2014-06-09
• Results First Posted: 2014-06-10
• Last Update Posted: 2014-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• adult patients, >=18 years of age;
• receiving out-patient treatment;
• experienced an inadequate response to previous or current treatment with methotrexate.

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Exclusion Criteria

• rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA;
• history of, or current, inflammatory joint disease other than RA;
• previous treatment with any cell-depleting therapies.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	methotrexate	-
1	rituximab [MabThera/Rituxan]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With an Adverse Event (AE)	Week 104

Secondary Outcome Measures

Name	Time	Method
Disease Activity Score Based on 28-Joint Count (DAS28)	Day 1 and Week 24	DAS28 was calculated from the number of swollen joints and tender joints using the 28 joint count; the erythrocyte sedimentation rate (ESR) measured in millimeters per hour \[mm/hr\]); and the Patient's Global Assessment of disease activity (participant-rated visual analog assessment \[VAS\]) with transformed scores with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Overall, a DAS28 score of less than or equal to (≤) 3.2 equals (=) low disease activity, and a DAS28 score of greater than (\>) 3.2 to 5.1 = moderate to high disease activity.
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category	Screening, Day 1, and Weeks 24 and 104	DAS28-based EULAR response criteria were used to measure individual response as no response, good, and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline greater than (\>)1.2 with DAS28 less than or equal to (≤)3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to ≤5.1 or change from baseline \>0.6 to ≤1.2 with DAS28 ≤5.1; non-responders: change from baseline ≤0.6 or change from baseline \>0.6 and ≤1.2 with DAS28 \>5.1.
Percentage of Participants With Changes in Bone Density	Screening, Weeks 48 and 104	Change in bone density in participants untreated with bisphosphonates was classified as percentage of participants with osteoporosis, osteopenia, or normal. In some participants, no determinations were available.