Observation Study of Remicade (Infliximab) Injection
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Purpose
The purpose of this study is to observe the safety and effectiveness of Remicade Injection (infliximab) under actual conditions of use in patients, and to learn more about its side effects. Patients with ankylosing spondylitis will have 6 Remicade injections and be observed for 24-30 weeks. Patients with rheumatoid arthritis will have 6 Remicade injections and be observed for 30 weeks. Patients will be observed for side effects and disease activity.
| Condition | Intervention | Phase |
|---|---|---|
|
Spondylitis, Ankylosing Arthritis, Rheumatoid |
Biological: infliximab |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community Time Perspective: Prospective |
| Official Title: | Post Marketing Surveillance of Remicade in Ankylosing Spondylitis, Rheumatoid Arthritis, Psoriatic Arthritis and Psoriasis Patients |
- Adverse events [ Time Frame: Before first dose; Week 2, 6 and then every 6-8 weeks for a maximum of 30 weeks depending on the Remicade dosing schedule; at the end of participation ] [ Designated as safety issue: Yes ]
- Disease activity [ Time Frame: Time Frame: Before first dose; Week 2, 6 and then every 6-8 weeks for a maximum of 30 weeks depending on the Remicade dosing schedule; at the end of participation ] [ Designated as safety issue: No ]
| Enrollment: | 1055 |
| Study Start Date: | May 2007 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients with ankylosing spondylitis |
Biological: infliximab
5mg/kg Remicade Injection given intravenously for more than 2 hours, and repeat the administration 2 and 6 weeks later. Only for patients who show response after the second injection, inject 5mg/kg of Remicade intravenously every 6~8 weeks. The injection should be discontinued for patients who don't show any reaction after the second injection.
Other Name: Remicade Injection, SCH 215596
|
| Patients with rheumatoid arthritis |
Biological: infliximab
3mg/kg Remicade Injection given as an intravenous infusion over a 2-hour period followed by additional 3mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter. Remicade must be given concomitantly with methotrexate. Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit within the first 12 weeks of treatment or after dose adjustment.
Other Name: Remicade Injection, SCH 215596
|
Detailed Description:
Continuous surveillance method: investigator will record continuously from the first patient since the day of contract to the numbers of patients of contract based on Remicade approval.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
This surveillance will be mainly taken at rheumatology departments in university or general hospitals where the patients with ankylosing spondylitis and rheumatoid arthritis are generally treated.
Inclusion Criteria:
- Ankylosing spondylitis: patients with ankylosing spondylitis who do not show adequate response to general treatments, and with increased serological indices related to severe axial symptoms and inflammation.
- Rheumatoid arthritis:
Patients with active disease in whom the response to disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate.
Patients with severe, active, and progressive disease not previously treated with methotrexate or other DMARDs.
Exclusion Criteria: None
Contacts and Locations More Information
No publications provided
| Responsible Party: | Janssen Korea, Ltd., Korea |
| ClinicalTrials.gov Identifier: | NCT00760669 History of Changes |
| Other Study ID Numbers: | CR100768, REMICADEAKS4004 |
| Study First Received: | September 24, 2008 |
| Last Updated: | November 20, 2012 |
| Health Authority: | South Korea: Korea Food and Drug Administration (KFDA) |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis Spondylitis, Ankylosing Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Ankylosis Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 16, 2013