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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00705484
Recruitment Status : Completed
First Posted : June 26, 2008
Results First Posted : July 24, 2018
Last Update Posted : August 27, 2018
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment
Ulcerative Colitis 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.

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Study Type : Observational
Actual Enrollment : 2239 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00705484

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Centocor, Inc.
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Study Director: Medical Director Merck Sharp & Dohme Corp.

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00705484    
Other Study ID Numbers: P04808
First Posted: June 26, 2008    Key Record Dates
Results First Posted: July 24, 2018
Last Update Posted: August 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
Additional relevant MeSH terms:
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Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents