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An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants

NCT00760669 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1061

Last updated 2013-10-29

Study results available
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Summary

The purpose of this observational study is to evaluate the safety and effectiveness of infliximab injection under actual conditions of use in participants, and to learn more about its adverse events.

Conditions

  • Spondylitis, Ankylosing
  • Arthritis, Rheumatoid
  • Psoriasis
  • Arthritis, Psoriatic

Interventions

DRUG

Infliximab; observational study

This is an observational study. Participants with RA, AS and PA receiving induction intravenous infusions (a fluid or a medicine delivered into a vein by way of a needle) of infliximab will be observed. Participants with RA will receive infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion over a 2-hour period followed by additional 3 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks (maintenance) thereafter up to 30 weeks. Participants with AS and PA will receive 5 mg/kg infliximab as an intravenous infusion over 2-hour period followed by additional doses at 2 and 6 weeks up to 24-30 weeks and 30 weeks, respectively.

DRUG

Methotrexate; observational study

Participants with RA will receive methotrexate based on physician's clinical judgement.

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    lead INDUSTRY

Principal Investigators

  • Janssen Korea, Ltd., Korea Clinical Trial · Janssen Korea, Ltd., Korea

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-04-30
Completion
2011-04-30

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Entities

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 NCT00760669 on ClinicalTrials.gov