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A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

NCT00299104 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 755

Last updated 2017-07-28

Study results available
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Summary

This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.

Conditions

Interventions

DRUG

folate

Intravenous repeating dose

DRUG

methotrexate

Oral or parenteral repeating dose

DRUG

methylprednisolone

Intravenous repeating dose

DRUG

placebo

Intravenous repeating dose

DRUG

rituximab

Intravenous repeating dose

Sponsors & Collaborators

Principal Investigators

  • Arndt Schottelius, M.D. · 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
2006-01-31
Primary Completion
2008-09-30
Completion
2013-07-31

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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 NCT00299104 on ClinicalTrials.gov