Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 13, 2013
Last verified: October 2013

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:
  • Adverse event rate and safety profile [ Time Frame: week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory parameters: hematology, blood chemistry, Ig levels, rheumatoid factor [ Time Frame: at intervals throughout study up to week 24 ] [ Designated as safety issue: No ]
  • Disease activity: swollen/tender joint count (DAS28) [ Time Frame: week 24 and week 104 ] [ Designated as safety issue: No ]
  • Change in bone density [ Time Frame: week 24 and week 104 ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: March 2008
Study Completion Date: May 2012
Primary Completion Date: May 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
Genders Eligible for Study:   Both
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

Sousse, Tunisia, 4000
Tunis, Tunisia, 1006
Tunis, Tunisia, 2046
Tunis, Tunisia, 1007
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche Identifier: NCT01000610     History of Changes
Other Study ID Numbers: ML20549
Study First Received: October 21, 2009
Last Updated: November 13, 2013
Health Authority: Tunisia: Ministry of Health

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses processed this record on February 27, 2015