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

Last updated: September 25, 2013
Sponsor: Janssen Korea, Ltd., Korea
Overall Status: Completed

Phase

N/A

Condition

Rosacea

Rash

Psoriatic Arthritis

Treatment

N/A

Clinical Study ID

NCT00760669
CR100768
REMICADEAKS4004
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants with ankylosing spondylitis who did not show adequate response to generaltreatments and with increased serological indices related to severe axial symptoms andinflammation

  • Participants with rheumatoid arthritis who show insufficient response to diseasemodifying antirheumatic drug (DMARD) including methotrexate

  • Participants with serious, active and progressive disease not previously treated withmethotrexate or other DMARD

  • Participant with moderate to serious plaque psoriasis who are unresponsive, contraindicant or intolerable to the systemic therapy including cyclosporine, methotrexateor Psoralen Ultra-Violet A (PUVA)

  • Participant with active, progressive, psoriatic arthritis who have shown insufficientresponse to DMARD treatment

Exclusion

Exclusion Criteria:

Study Design

Total Participants: 1061
Study Start date:
May 01, 2007
Estimated Completion Date:
April 30, 2011

Study 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 to adverse events in participants with ankylosing spondylitis (chronic inflammatory condition affecting the axial joints), rheumatoid arthritis (chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures), psoriasis (scaly skin rash) and psoriatic arthritis (a type of inflammatory arthritis associated with psoriasis). Participants with rheumatoid arthritis will receive 6 doses of infliximab 3 milligram per kilogram (mg/kg) as an intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6 and will be observed for 30 weeks; and those with ankylosing spondylitis, psoriasis and psoriatic arthritis will also receive 6 doses of injection and will be observed for 24 to 30 weeks. Efficacy will be evaluated by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Erythrocyte Sedimentation Rate (ESR), C-reactive protein (CRP), Psoriasis Area and Severity Index (PASI), swollen joint counts and tender joint count. Participants' safety will be monitored throughout the study.