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An Efficacy and Safety Study of Infliximab in Participants With Rheumatoid Arthritis

NCT00896168 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2013-09-13

Study results available
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Summary

The purpose of this study is to compare the effectiveness of iInfliximab plus methotrexate (MTX) in treatment of Rheumatoid rheumatoid Arthritis arthritis (RA) (it is an autoimmune disease that causes pain, swelling, stiffness and loss of function in joints) in participants with moderate disease versus participants with severe disease and to compare the efficacy and safety of the MTX subgroups.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Infliximab

Infliximab 3 mg per kg intravenous infusion at Week 0, 2, 6, 14 and 22.

DRUG

Methotrexate

MTX stable dose (7.5 to 20 mg/week equal to the dose used before participation in the study) for 22 weeks.

Sponsors & Collaborators

  • Xian-Janssen Pharmaceutical Ltd.

    lead INDUSTRY

Principal Investigators

  • Xian-Janssen Pharmaceutical Ltd. Clinical Trial · Xian-Janssen Pharmaceutical Ltd.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-04-30
Completion
2008-04-30

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Entities

Drugs

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 NCT00896168 on ClinicalTrials.gov