Clinical trial NCT00760669: An Observational Study of Infliximab Injection in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Participants
Official title: Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spondylitis, Ankylosing
Arthritis, Rheumatoid
Psoriasis
Arthritis, Psoriatic
Keywords: Spondylitis, Ankylosing
Arthritis, Rheumatoid
Psoriasis
Arthritis, Psoriatic
Infliximab
Remicade
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2008-09-26
Enrollment: 1061
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participant with ankylosing spondylitis, rheumatoid arthritis, psoriasis and psoriatic arthritis will be observed at rheumatology departments in university or general hospitals where they are commonly treated.

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 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.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

None

Primary outcomes:
measure: Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 30
timeFrame: Baseline and Week 30
measure: Change From Baseline in Erythrocytic Sedimentation Rate (ESR) at Week 30
timeFrame: Baseline and Week 30
measure: Change From Baseline in C-Reactive Protein (CRP) at Week 30
timeFrame: Baseline and Week 30
measure: Change From Baseline in Number of Swollen Joints at Week 30
timeFrame: Baseline and Week 30
measure: Change From Baseline in Number of Tender Joints at Week 30
timeFrame: Baseline and Week 30
measure: Change From Baseline in Participants With Psoriasis Area and Severity Index (PASI) at Week 30
timeFrame: Baseline and Week 30
measure: Overall Efficacy Assessment
timeFrame: Baseline up to Week 30
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 30
measure: Number of Participants With Unexpected Adverse Events
timeFrame: Baseline up to Week 30
measure: Number of Participants With Adverse Drug Reactions
timeFrame: Baseline up to Week 30
measure: Number of Participants With Adverse Events (AEs) Caused by Drug Misuse, Abuse and Drug Interaction
timeFrame: Baseline up to Week 30
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: