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

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ClinicalTrials.gov Identifier: NCT00727298
Recruitment Status : Completed
First Posted : August 1, 2008
Results First Posted : September 12, 2012
Last Update Posted : December 1, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

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

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 Design

Study Type : Observational
Actual Enrollment : 4485 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases
Study Start Date : February 2006
Primary Completion Date : August 2011
Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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.
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


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Experiencing at Least One Adverse Event [ Time Frame: 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 :
  1. Clinicians' Impression of Disease Severity From Baseline to Week 102 [ Time Frame: 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.

  2. Clinicians' Impression of Therapeutic Efficacy [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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:

More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00727298     History of Changes
Other Study ID Numbers: P04840
First Posted: August 1, 2008    Key Record Dates
Results First Posted: September 12, 2012
Last Update Posted: December 1, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Arthritis
Psoriasis
Crohn Disease
Spondylitis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Infliximab
Dermatologic Agents
Gastrointestinal Agents