European Safety Registry in Ulcerative Colitis (P04808) (OPUS)

Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program

This is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (UC).

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Biological: infliximab; Drug: Standard Therapy

Detailed Description

This is a prospective, observational, post-marketing safety surveillance registry of UC participants treated with Remicade or another standard therapy. Registry centers are targeted to enroll a total of 2000 participants (1000 Remicade participants and 1000 standard therapy participants) and to follow them for a period of up to 5 years. Participants who started the registry on standard therapy may switch over to Remicade.

• Study Type: Observational
• Enrollment (Actual): 2239

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult participants, ages 18 years and older, with a diagnosis of moderate-to-severe active UC will be eligible to enroll in the registry.

Description

Inclusion Criteria:

• 18 years of age, of either sex, and of any race.
• Moderate-to-severe active UC, as defined by assessment by the treating physician.

• Must, within 30 days of Baseline, either:

  • Initiate or have a dose increase of immunosuppressive drug(s), including but not limited to systemic steroids (budesonide is considered a topical steroid), azathioprine (AZA), or methotrexate (participants in this category must be Remicade naïve) or
  • Initiate Remicade. Participants who have been treated in the past with Remicade, but who have discontinued for any reason and who are scheduled to receive Remicade within 30 days of the baseline visit must have a Remicade-free interval of no less than 90 days from the date of the next expected infusion
• Must be willing to give written informed consent and must be able to adhere to the procedural requirements of the registry.
• Must be evaluated for active and inactive (latent) tuberculosis (TB) as suggested by local guidelines or as required by the Remicade label for participants starting Remicade.

Exclusion Criteria:

• Female who is known to be pregnant or nursing.
• Previously treated with any other (investigational) biological drug for UC( other than Remicade) prior to Baseline.
• In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
• Participating in a blinded trial.

In addition, participants with conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC) should not be treated with Remicade.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Remicade Group; 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.	Biological: infliximab; The treating physician will determine the treatment regimen and dose of Remicade.; Other Names: Remicade; SCH 215596
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories	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.	Up to 5 years.

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Collaborators: Centocor, Inc.

Publications and helpful links

General Publications

• Panes J, Lindsay JO, Teich N, Lindgren S, Colombel JF, Cornillie F, Flynn HA, Huyck S, Stryszak P, Yao R, Philip G, Reinisch W. Five-year Safety Data From OPUS, a European Observational Safety Registry for Adults With Ulcerative Colitis Treated With Originator Infliximab [Remicade(R)] or Conventional Therapy. J Crohns Colitis. 2019 Sep 19;13(9):1148-1157. doi: 10.1093/ecco-jcc/jjz048.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2007
• Primary Completion (Actual): October 20, 2016
• Study Completion (Actual): October 20, 2016

Study Registration Dates

• First Submitted: June 23, 2008
• First Submitted That Met QC Criteria: June 25, 2008
• First Posted (Estimate): June 26, 2008

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: P04808

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf