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RESTART C0168Z05 Rheumatoid Arthritis Study

NCT00714493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2013-09-12

Study results available
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Summary

The purpose of this study is to assess the effectiveness of treatment in patients with active rheumatoid arthritis who are having an inadequate response to at least 3 months of treatment with etanercept or adalimumab in addition to methotrexate.

Conditions

Interventions

BIOLOGICAL

Infliximab

3 mg/kg at week 0,2,6; Increase to 5mg/kg or 7 mg/kg based on EULAR response

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Centocor Ortho Biotech Services, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Centocor Ortho Biotech Services, L.L.C. Clinical Trial · Centocor Ortho Biotech Services, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2010-01-31
Completion
2010-06-30

Countries

  • United States
  • Austria
  • Canada
  • Finland
  • France
  • Germany
  • Israel
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00714493 on ClinicalTrials.gov