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

Completed

• Conditions: Crohn's Disease; Spondylitis, Ankylosing; Psoriasis; Arthritis, Rheumatoid; Arthritis, Psoriatic
• Interventions: Biological: Infliximab

• Registration Number: NCT00727298
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

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.

Study Timeline

• Study Start: 2006-02
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-30
• Study First Posted: 2008-08-01
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2012-08-10
• Results First Submitted QC: 2012-08-10
• Results First Posted: 2012-09-12
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-30
• Last Update Posted: 2015-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 4485

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.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infliximab	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Experiencing at Least One Adverse Event	Baseline to Month 24	An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.

Secondary Outcome Measures

Name	Time	Method
Clinicians' Impression of Disease Severity From Baseline to Week 102	Baseline, Week 6, Week 14, Week 22, Week 54, Week 102	Participant severity of disease was assessed at baseline, Week 6, Week 14, Week 22, Week 54, and Week 102 on the basis of the treating clinician's opinion of the participant being normal, not at all ill, borderline ill, mildly ill, moderately ill, markedly ill, severely ill, or extreme severe illness. Each time point was compared to the previous visit.
Clinicians' Impression of Therapeutic Efficacy	Week 6, Week 14, Week 22, Week 54, Week 102	Therapeutic efficacy was rated by the treating physician at each time point as moderate-to-clear improvement, no change, not assessable, mild-to-slight improvement, very good-to-full improvement, or worsened. Each time point was compared to the previous visit.