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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00934648
Recruitment Status : Completed
First Posted : July 8, 2009
Results First Posted : June 10, 2014
Last Update Posted : June 10, 2014
Information provided by (Responsible Party):
Hoffmann-La Roche

July 6, 2009
July 8, 2009
May 7, 2014
June 10, 2014
June 10, 2014
October 2007
November 2010   (Final data collection date for primary outcome measure)
Percentage of Participants With an Adverse Event (AE) [ Time Frame: Week 104 ]
  • AEs and AE profile [ Time Frame: Week 104 ]
  • Laboratory parameters [ Time Frame: At intervals throughout study, up to week 24 ]
Complete list of historical versions of study NCT00934648 on Archive Site
  • Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Categorical DAS responders [ Time Frame: Week 24, and week 104 ]
  • Change in bone density [ Time Frame: Week 24 and week 104 ]
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A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate
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.
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Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: rituximab [MabThera/Rituxan]
    1000mg iv on days 1 and 15
  • Drug: methotrexate
    10-25mg weekly
Experimental: 1
  • Drug: rituximab [MabThera/Rituxan]
  • Drug: methotrexate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2010
November 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

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

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP