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

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: rituximab [MabThera/Rituxan] Drug: methotrexate Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Drug: methotrexate
10-25mg weekly

Primary Outcome Measures :
  1. Percentage of Participants With an Adverse Event (AE) [ Time Frame: Week 104 ]

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00934648

Casablanca, Morocco, 20000
Casablanca, Morocco, 20100
Marrakech, Morocco, 40000
Rabat, Morocco, 10150
Salé, Morocco, 15045
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00934648     History of Changes
Other Study ID Numbers: ML20546
First Posted: July 8, 2009    Key Record Dates
Results First Posted: June 10, 2014
Last Update Posted: June 10, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Nucleic Acid Synthesis Inhibitors