Trials / Completed
CompletedNCT00727298
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 4,485 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2006-02-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2008-08-01
- Last updated
- 2015-12-01
- Results posted
- 2012-09-12
Source: ClinicalTrials.gov record NCT00727298. Inclusion in this directory is not an endorsement.