A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a TNF-Blocker.

NCT ID: NCT00424502

Last Updated: 2016-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2009-10-31

Brief Summary

This single arm study will evaluate the efficacy and safety of MabThera in patients with active rheumatoid arthritis whose current treatment with one or more TNF blocker had produced an inadequate response. Patients will receive MabThera (1g infusion) on day 1 and day 15, and will continue on their basic methotrexate therapy (10-25mg/week). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

rituximab [MabThera/Rituxan]

Intervention Type: DRUG

1g iv on days 1 and 15

Methotrexate

Intervention Type: DRUG

10-25mg po/week

Interventions

rituximab [MabThera/Rituxan]

1g iv on days 1 and 15

Intervention Type: DRUG

Methotrexate

10-25mg po/week

Intervention Type: DRUG

Other Intervention Names

MabThera/Rituxan

Eligibility Criteria

Inclusion Criteria

• adult patients, >=18 years of age;
• diagnosed RA for >=3 months prior to first administration of study medication;
• inadequate response or intolerance to >=1 anti-TNF therapies, alone or in combination with methotrexate;
• if using NSAIDS, analgesics or oral corticosteroids, must be on a stable dose for >=2 weeks prior to start of study.

Exclusion Criteria

• other chronic inflammatory diseases;
• use of parental corticosteroids within 4 weeks prior to screening;
• severe heart failure, or severe, uncontrolled cardiac disease.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Budapest, , Hungary

Budapest, , Hungary

Debrecen, , Hungary

Countries

Hungary

Other Identifiers

ML20538

Identifier Type: -

Identifier Source: org_study_id