FindTrial
Sign In

Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00074438
Enrollment
465
Registered
2003-12-15
Start date
2003-06-30
Completion date
2011-07-31
Last updated
2013-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rituxan, RA

Brief summary

This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).

Interventions

DRUGrituximab

Intravenous repeating dose

DRUGcorticosteroids

Intravenous repeating dose

DRUGplacebo

Intravenous repeating dose

DRUGmethotrexate

Oral or parenteral repeating dose

Sponsors

Roche Pharma AG
CollaboratorINDUSTRY
Genentech, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

Eligibility criteria include, but are not limited to the following: * Are between the ages of 18 and 80 years. * Have been diagnosed with rheumatoid arthritis for at least 6 months. * Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).

Design outcomes

Primary

MeasureTime frame
Proportion of patients with an ACR20 response24 weeks

Secondary

MeasureTime frame
Proportion of patients with ACR(50,70) responses24 weeks
Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026