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

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00727298
First received: July 30, 2008
Last updated: November 7, 2014
Last verified: November 2014

July 30, 2008
November 7, 2014
February 2006
August 2011   (final data collection date for primary outcome measure)
Number of Participants Experiencing at Least One Adverse Event [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: Yes ]
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.
Rate and type of adverse events. [ Time Frame: not specified in the protocol ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00727298 on ClinicalTrials.gov Archive Site
  • Clinicians' Impression of Disease Severity From Baseline to Week 102 [ Time Frame: Baseline, Week 6, Week 14, Week 22, Week 54, Week 102 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Week 6, Week 14, Week 22, Week 54, Week 102 ] [ Designated as safety issue: No ]
    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.
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 ]
Not Provided
Not Provided
 
Post Marketing Surveillance Study of Remicade in Patients With Chronic Inflammatory Diseases (P04840)
Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

  • Arthritis, Rheumatoid
  • Spondylitis, Ankylosing
  • Arthritis, Psoriatic
  • Psoriasis
  • Crohn's Disease
Biological: 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.
Other Names:
  • Remicade
  • SCH 215596
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: Biological: Infliximab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4485
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00727298
P04840
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Centocor, Inc.
Not Provided
Merck Sharp & Dohme Corp.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP