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

Rheumatoid Arthritis Clinical Trial

Official title:

An Expanded Access Program to Assess the Safety of MabThera in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502996
• Other study ID #: ML19385
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2007
• Last updated: November 2, 2015
• Start date: February 2006
• Est. completion date: April 2010

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients, >=18 years of age;

• rheumatoid arthritis >=6 months;

• lack of response to 1-5 DMARDs or biological agents;

• rheumatoid factor positive.

Exclusion Criteria:

• other chronic inflammatory articular disease or systemic rheumatic disease;

• joint or bone surgery during 8 weeks prior to randomization;

• previous treatment with any cell-depleting therapy.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Methotrexate
>=15 mg po/week
• rituximab [MabThera/Rituxan]
1g iv on days 1 and 15

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Brazil,  Chile,  Colombia,  Ecuador,  El Salvador,  Mexico,  Peru,  Uruguay,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse event incidence and profile		Throughout study	No