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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: rituximab [MabThera/Rituxan]; Drug: methotrexate

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 4

Contacts and Locations

Study Locations

• Morocco
  • Casablanca, Morocco, 20100
  • Casablanca, Morocco, 20000
  • Marrakech, Morocco, 40000
  • Rabat, Morocco, 10150
  • Salé, Morocco, 15045

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants With an Adverse Event (AE)	Week 104

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score Based on 28-Joint Count (DAS28)	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.	Day 1 and Week 24
Percentage of Participants With a DAS28 Response by European League Against Rheumatism (EULAR) Category	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.	Screening, Day 1, and Weeks 24 and 104
Percentage of Participants With Changes in Bone Density	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.	Screening, Weeks 48 and 104

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 8, 2009

Study Record Updates

• Last Update Posted (Estimate): June 10, 2014
• Last Update Submitted That Met QC Criteria: June 9, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Rituximab; Methotrexate
• Other Study ID Numbers: ML20546