MedTrace Logo

A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

NCT00299130 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 511

Last updated 2017-04-17

Study results available
· View outcomes & findings →

Summary

This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).

Conditions

Interventions

DRUG

Folate

A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.

DRUG

Methotrexate

A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.

DRUG

Methylprednisolone

Intravenous infusion

DRUG

Placebo

Placebo to rituximab intravenous infusion

DRUG

Rituximab

Intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2008-06-30
Completion
2013-07-31

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00299130 on ClinicalTrials.gov