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

• 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: Merck Sharp & Dohme Corp.
• Collaborator: Centocor, Inc.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

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
• Actual Primary Completion Date: August 2011
• Actual Study Completion Date: August 2011

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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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:

• None

Contacts and Locations

No Contacts or Locations Provided

More Information

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

Additional relevant MeSH terms:

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