European Safety Registry in Ulcerative Colitis (P04808)

NCT ID: NCT00705484

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2239 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-06-01
• Study Completion Date: 2016-10-20

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.

Conditions

Ulcerative Colitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

infliximab

Intervention Type: BIOLOGICAL

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

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.

Standard Therapy

Intervention Type: 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.

Interventions

infliximab

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

Intervention Type: BIOLOGICAL

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.

Intervention Type: DRUG

Other Intervention Names

Remicade; SCH 215596

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor, Inc.

INDUSTRY

Sponsor Role: collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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.

Reference Type: DERIVED

PMID: 30809631 (View on PubMed)

Other Identifiers

P04808

Identifier Type: -

Identifier Source: org_study_id