Status:
COMPLETED
An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Spondylitis, Ankylosing
Arthritis, Rheumatoid
Eligibility:
All Genders
Brief 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.
Detailed Description
This is an observational, prospective (study following participants forward in time) study to assess safety and efficacy of infliximab injection under post-marketing use and identify problems related ...
Eligibility Criteria
Inclusion
- Participants with ankylosing spondylitis who did not show adequate response to general treatments and with increased serological indices related to severe axial symptoms and inflammation
- Participants with rheumatoid arthritis who show insufficient response to disease modifying antirheumatic drug (DMARD) including methotrexate
- Participants with serious, active and progressive disease not previously treated with methotrexate or other DMARD
- Participant with moderate to serious plaque psoriasis who are unresponsive, contra indicant or intolerable to the systemic therapy including cyclosporine, methotrexate or Psoralen Ultra-Violet A (PUVA)
- Participant with active, progressive, psoriatic arthritis who have shown insufficient response to DMARD treatment
Exclusion
- None
Key Trial Info
Start Date :
May 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
1061 Patients enrolled
Trial Details
Trial ID
NCT00760669
Start Date
May 1 2007
End Date
April 1 2011
Last Update
October 29 2013
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