Status:
COMPLETED
European Safety Registry in Ulcerative Colitis (P04808)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Centocor, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 20 2016
Estimated Enrollment :
2239 Patients enrolled
Trial Details
Trial ID
NCT00705484
Start Date
June 1 2007
End Date
October 20 2016
Last Update
August 27 2018
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