Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (Study P04840) - Full Text View

Sponsors and Collaborators:	Schering-Plough Centocor, Inc.
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00727298

Purpose

This study will be performed to evaluate and document the safety and efficacy of Remicade in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.

Condition	Intervention
Arthritis, Rheumatoid Spondylitis, Ankylosing Arthritis, Psoriatic Psoriasis Crohn's Disease	Biological: Infliximab

Genetics Home Reference related topics: ankylosing spondylitis Crohn disease

MedlinePlus related topics: Ankylosing Spondylitis Crohn's Disease Psoriasis Rheumatoid Arthritis

Drug Information available for: Infliximab

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

Rate and type of adverse events. [ Time Frame: not specified in the protocol ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Improvement of the clinical condition (as measured by using an adapted clinical global impressions scale) and the global evaluation of change in disease status by the physician. [ Time Frame: not specified in the protocol ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	February 2006
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Remicade Remicade for the treatment of chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.	Biological: Infliximab Not specified in the protocol

Detailed Description:

This study population was chosen from a non-probability sample.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects treated with Remicade by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.

Criteria

Inclusion Criteria:

Subjects treated with Remicade by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00727298

Contacts

Contact: SP Clinical Trial Registry Call Center

1-888-772-8734

Locations

Germany
Coordinating Location	Recruiting
Munich, Germany

Sponsors and Collaborators

Schering-Plough

Centocor, Inc.

More Information

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P04840
Study First Received:	July 30, 2008
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00727298
Health Authority:	Germany: Paul-Ehrlich-Institut

Study placed in the following topic categories:

Infliximab
Gastrointestinal Diseases
Arthritis, Rheumatoid
Inflammatory Bowel Diseases
Bone Diseases
Musculoskeletal Diseases
Psoriasis
Arthritis
Connective Tissue Diseases
Spondylitis, Ankylosing
Spondylarthritis
Spondylitis
Spondylarthropathies

Ankylosis
Spinal Diseases
Autoimmune Diseases
Skin Diseases
Arthritis, Psoriatic
Joint Diseases
Spondylarthropathy
Rheumatic Diseases
Intestinal Diseases
Digestive System Diseases
Crohn Disease
Gastroenteritis
Skin Diseases, Papulosquamous

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