European Safety Registry in Ulcerative Colitis (P04808)

NCT00705484 | Completed Results DMC

• 1 other identifier: P04808
• Study Type: observational
• Target: 2,239
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

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

Interventions

infliximab BIOLOGICAL

The treating physician will determine the treatment regimen and dose of Remicade.

Also known as: Remicade, SCH 215596

Remicade Group

Standard Therapy DRUG

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.

Standard Therapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Centocor, Inc.: collaborator

Related Publications (1)

• 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.

  PMID: 30809631 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Infliximab; Standard of Care

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 26, 2008
• Study Start: June 1, 2007
• Primary Completion: October 20, 2016
• Study Completion: October 20, 2016
• Last Updated: August 27, 2018
• Results First Posted: July 24, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share