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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Psoriasis; Spondylitis, Ankylosing; Arthritis, Psoriatic; Crohn's Disease; Arthritis, Rheumatoid

Treatments: Biological: Infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00727298

P04840

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,485 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,485 participants in 1 patient group

Infliximab

Description:

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.

Treatment:

Biological: Infliximab