NCT00760669

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

Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,061 (actual)
• Sponsor: Janssen Korea, Ltd., Korea · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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 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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-05-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-09-26
• Last updated: 2013-10-29
• Results posted: 2013-08-12