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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: October 21, 2009
Last updated: July 7, 2017
Last verified: June 2017
In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc 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 target sample size is <50

Condition Intervention Phase
Rheumatoid Arthritis Drug: rituximab [MabThera/Rituxan] Drug: methotrexate Drug: methylprednisolone Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants Reporting Adverse Events (AEs) [ Time Frame: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks ]

Secondary Outcome Measures:
  • Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24 [ Time Frame: Baseline and Week 24 ]
    The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: [VAS] 0 equals (=) no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Scores less than (<) 2.6 indicate best disease control and scores greater than or equal to (≥) 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. The average improvement at each visit to the group score is equal to the formula (Previous DAS28 minus [-] current DAS 28)/ Previous DAS 28 x 100. Negative percentages indicate that the participant has worsened in comparison to last evaluation, and positive percentages indicate improvement of its DAS28 score and correlated with a bettering of clinical situation.

  • Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24 [ Time Frame: Baseline and Week 24 ]
    The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [VAS: 0 = no disease activity to 100 = maximum disease activity] and the ESR for a total possible score of 0 to 10. Scores < 2.6 indicate best disease control and scores ≥ 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score < 2.6. An improvement of >1.2 was considered to be clinically significant improvement.

  • Change in Bone Density (in Participants Untreated With Bisphosphonates) [ Time Frame: Screening and Week 84 ]
    Bone mineral density test was performed using x-ray radiation and the values of bone density were provided directly by the apparatus as grams per square centimeter (g/cm^2) . T-score is the number of standard deviations above or below the mean for a healthy 30 year old adult of the same sex and ethnicity as the participant. A T-score with above -1 is normal bone density level. A T-score between -1 and -2.5 means that the bone density is below normal and it might be a sign of an osteopenia and may also lead into osteoporosis. A T-score below -2.5 indicates osteoporosis.

Enrollment: 18
Actual Study Start Date: March 17, 2008
Study Completion Date: May 16, 2012
Primary Completion Date: May 16, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm Drug: rituximab [MabThera/Rituxan]
1000 mg iv infusion on days 1 and 15
Drug: methotrexate
10-25 mg weekly (oral or parenteral)
Drug: methylprednisolone
100 mg iv prior to each rituximab infusion


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
  • rheumatoid arthritis DAS28 >/= 3.2
  • receiving treatment on an outpatient basis
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01000610

Hopital Farhat Hached; Service Rhumatologie
Sousse, Tunisia, 4000
Hopital Charles Nicole; Service Rhumatologie
Tunis, Tunisia, 1006
Hopital La Rabta; Service Rhumatologie
Tunis, Tunisia, 1007
Hopital Mongi Slim; Service Rhumatologie
Tunis, Tunisia, 2046
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01000610     History of Changes
Other Study ID Numbers: ML20549
Study First Received: October 21, 2009
Results First Received: February 27, 2015
Last Updated: July 7, 2017

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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 processed this record on August 22, 2017