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Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)

NCT ID: NCT00727298

Last Updated: 2015-12-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4485 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2011-08-31

Brief Summary

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

Detailed Description

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

The safety population consisted of all participants with at least one documented infusion of infliximab.

The evaluable population consisted of all participants that were \>=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.

Conditions

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Arthritis, Rheumatoid Spondylitis, Ankylosing Arthritis, Psoriatic Psoriasis Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Infliximab

Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.

Infliximab

Intervention Type BIOLOGICAL

Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.

Interventions

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Infliximab

Infliximab administered at a dose of 3-10 mg/kg at Week 0, Week 2, and Week 6, and every 4-8 weeks thereafter for 24 months for the treatment of chronic inflammatory disease.

Intervention Type BIOLOGICAL

Other Intervention Names

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Remicade SCH 215596

Eligibility Criteria

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Inclusion Criteria

* Participants treated with infliximab 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centocor, Inc.

INDUSTRY

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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P04840

Identifier Type: -

Identifier Source: org_study_id