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: 09/19/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: October 6, 2008 at 2:44:17 PM