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Safety and Tolerability of Rituxan With Methotrexate and Etanercept or Methotrexate and Adalimumab in Patients With Active Rheumatoid Arthritis

NCT00298272 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2015-09-28

Study results available
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Summary

The primary objective of this study was to evaluate the tolerability and safety of rituximab in combination with methotrexate (MTX) and etanercept or adalimumab in participants with active rheumatoid arthritis (RA). The secondary objective was to explore the efficacy of rituximab in combination with MTX and etanercept or adalimumab in participants with active RA.

Conditions

Interventions

BIOLOGICAL

IDEC-C2B8 (rituximab)

Participants will receive 500 mg rituximab on Day 1 and Day 15

DRUG

Placebo

Participants will receive placebo on Day 1 and Day 15

DRUG

Methotrexate

Participants must have been treated with MTX ≥15 mg per week and ≤25 mg per week (dose may have been as low as 10 mg if unable to tolerate higher dose) for at least 12 weeks immediately prior to Day 1, at a stable dose for at least 4 weeks and was continued for the study duration.

DRUG

Etanercept

Participants must have been treated with etanercept at 50 mg per week (25 mg twice per week or 50 mg once per week).

DRUG

Adalimumab

Participants must have been treated with adalimumab at 40 mg every other week for at least 12 weeks immediately prior to Day 1.

DRUG

Methylprednisolone

Methylprednisolone 100 mg IV was administered by slow infusion to be completed at least 30 minutes prior to each infusion of rituximab or placebo.

DIETARY_SUPPLEMENT

Folate

All subjects also received a stable dose of folate (≥5 mg per week).

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-05-31
Primary Completion
2009-04-30
Completion
2011-07-31

Countries

  • United States

Study Locations

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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 NCT00298272 on ClinicalTrials.gov