Observation Study of Remicade (Infliximab) Injection (Study P05725) - Full Text View

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00760669

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
Spondylitis, Ankylosing Arthritis, Rheumatoid	Biological: infliximab

Genetics Home Reference related topics: ankylosing spondylitis

MedlinePlus related topics: Ankylosing Spondylitis Rheumatoid Arthritis

Drug Information available for: Methotrexate Infliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Ecologic or Community, Prospective
Official Title:	Remicade Injection Post Marketing Surveillance Protocol

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

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: 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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	600
Study Start Date:	May 2007
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1 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.
Group 2 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.

Groups/Cohorts

Assigned Interventions

Group 1

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.

Group 2

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.

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

Study Population

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.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00760669

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Korea, Republic of
Coordinating Location	Recruiting
Seoul, Korea, Republic of

Sponsors and Collaborators

Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P05725
Study First Received:	September 24, 2008
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00760669
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Study placed in the following topic categories:

Spinal Diseases
Autoimmune Diseases
Infliximab
Spondylarthropathy
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Bone Diseases
Musculoskeletal Diseases

Arthritis
Connective Tissue Diseases
Methotrexate
Spondylitis, Ankylosing
Spondylarthritis
Spondylitis
Ankylosis
Spondylarthropathies

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Gastrointestinal Agents
Antirheumatic Agents

Infection
Dermatologic Agents
Pharmacologic Actions
Bone Diseases, Infectious

ClinicalTrials.gov processed this record on January 14, 2009