European Safety Registry in Ulcerative Colitis (P04808) (OPUS)
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|ClinicalTrials.gov Identifier: NCT00705484|
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : July 24, 2018
Last Update Posted : August 27, 2018
|Condition or disease||Intervention/treatment|
|Ulcerative Colitis||Biological: infliximab Drug: Standard Therapy|
|Study Type :||Observational|
|Actual Enrollment :||2239 participants|
|Official Title:||Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program|
|Actual Study Start Date :||June 1, 2007|
|Actual Primary Completion Date :||October 20, 2016|
|Actual Study Completion Date :||October 20, 2016|
Participants with no prior exposure to Remicade or who have been treated with Remicade in the past, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who have been treated in the past with Remicade must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion.
The treating physician will determine the treatment regimen and dose of Remicade.
Standard Therapy Group
Participants who are scheduled to receive standard therapy (defined as initiation or dose-increase of corticosteroids and/or immunosuppressants) that does not include Remicade. Standard therapy participants must not have previously received Remicade for UC or any other condition.
Drug: Standard Therapy
The standard therapy group will consist of participants receiving a treatment regimen that does not include Remicade. The treatment of each standard therapy participant will be left to the discretion of the treating physician and may change during the course of a participant's participation in the registry.
- Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories [ Time Frame: Up to 5 years. ]The nine AE categories are as follows: 1) Serious infections, including infections listed as Serious AEs, tuberculosis, invasive fungal infections, other opportunistic infections, salmonellosis; 2) Infusion-related reactions including delayed hypersensitivity and anaphylactic reactions, and change in severity of infusion-related reactions over time; 3) Fatalities, analyzed by cause; 4)Worsening or new congestive heart failure; 5) Central and peripheral demyelinating neurological disorders; 6) Hematologic conditions such as idiopathic thrombocytopenic purpura, thrombotic thrombocytopenic purpura, thrombocytopenia, pancytopenia, granulocytopenia, leucopenia, hemolytic anemia, aplastic anemia, and thromboembolic events; 7) Malignancies, especially lymphoma, colorectal cancer, and skin cancer; 8) Autoimmune disorders such as lupus and lupus-like syndromes; 9) Hepatobiliary events including autoimmune hepatitis, primary sclerosing cholangitis, and liver function test abnormalities.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00705484
|Study Director:||Medical Director||Merck Sharp & Dohme Corp.|