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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
  Purpose

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

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 4485
Study Start Date: February 2006
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  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

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:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00727298     History of Changes
Other Study ID Numbers: P04840
Study First Received: July 30, 2008
Results First Received: August 10, 2012
Last Updated: November 7, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

ClinicalTrials.gov processed this record on November 25, 2014