Trial Information

Summary: A Non-Comparative Study to Assess the Safety of MabThera (Rituximab) in Patients With Rheumatoid Arthritis.

Status: No longer recruiting

Protocol Number: ML19385

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An expanded access program to assess the safety of MabThera in patients with rheumatoid arthritis

Brief Summary: This single arm study will assess the safety of MabThera plus methotrexate in patients with rheumatoid arthritis who have had a lack of response to 1-5 DMARDs or biological agents. Patients will receive MabThera (1g i.v.) on days 1 and 15, concomitantly with methotrexate >=15mg p.o./week. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 350.

Study Phase: IV

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Non-Randomized
• Masking: Open Label
• Control: Uncontrolled
• Assignment: Single Group
• Endpoints: Safety

Study Type:

Condition: Rheumatoid Arthritis

Intervention Type: Drug

Intervention Name: rituximab [MabThera/Rituxan]

Primary Outcome: 1. Adverse event incidence and profile Time frame: Throughout study

Key Secondary Outcomes: 1. None Time frame: None

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: February, 2006

Trial Registration Date: 07/19/2007

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 1:57:02 PM