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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Psoriasis; Spondylitis, Ankylosing; Arthritis, Psoriatic; Arthritis, Rheumatoid

Treatments: Drug: Infliximab; observational study; Drug: Methotrexate; observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT00760669

CR100768

REMICADEAKS4004 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,061 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

1,061 participants in 1 patient group

Participants Receiving Infiximab

Description:

Participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PA) receiving infliximab injection will be observed.

Treatment:

Drug: Methotrexate; observational study

Drug: Infliximab; observational study