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

NCT ID: NCT00760669

Last Updated: 2013-10-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1061 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2011-04-30

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.

Conditions

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

Keywords

Spondylitis, Ankylosing; Arthritis, Rheumatoid; Psoriasis; Arthritis, Psoriatic; Infliximab; Remicade

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants Receiving Infiximab

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

Infliximab; observational study

Intervention Type: DRUG

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.

Methotrexate; observational study

Intervention Type: DRUG

Participants with RA will receive methotrexate based on physician's clinical judgement.

Interventions

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.

Intervention Type: DRUG

Methotrexate; observational study

Participants with RA will receive methotrexate based on physician's clinical judgement.

Intervention Type: DRUG

Other Intervention Names

Remicade Injection

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Countries

South Korea

Other Identifiers

REMICADEAKS4004

Identifier Type: OTHER

Identifier Source: secondary_id

CR100768

Identifier Type: -

Identifier Source: org_study_id