European Safety Registry in Ulcerative Colitis (P04808)

Completed

• Conditions: Ulcerative Colitis
• Interventions: Biological: infliximab; Drug: Standard Therapy

• Registration Number: NCT00705484
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

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 Timeline

• Study Start: 2007-06-01
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-06-25
• Study First Posted: 2008-06-26
• Primary Completion: 2016-10-20
• Study Completion: 2016-10-20
• Results First Submitted: 2017-10-09
• Results First Submitted QC: 2017-10-09
• Status Verified: 2018-07
• Results First Posted: 2018-07-24
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2239

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Remicade Group	infliximab	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.
Standard Therapy Group	Standard Therapy	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories	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.