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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00934648
First received: July 6, 2009
Last updated: June 9, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Drug: rituximab [MabThera/Rituxan]
Drug: methotrexate
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:
  • Percentage of Participants With an Adverse Event (AE) [ Time Frame: Week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease Activity Score Based on 28-Joint Count (DAS28) [ Time Frame: Day 1 and Week 24 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: October 2007
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15
Drug: methotrexate
10-25mg weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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 ClinicalTrials.gov identifier: NCT00934648

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00934648     History of Changes
Other Study ID Numbers: ML20546
Study First Received: July 6, 2009
Results First Received: May 7, 2014
Last Updated: June 9, 2014
Health Authority: Morocco: Ministry of Public Health

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

ClinicalTrials.gov processed this record on September 18, 2014