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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Drug: Standard Therapy; Biological: infliximab

Study type: Observational

Funder types: Industry

Identifiers

NCT00705484

P04808

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,239 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,239 participants in 2 patient groups

Remicade Group

Description:

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.

Treatment:

Biological: infliximab

Standard Therapy Group

Description:

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.

Treatment:

Drug: Standard Therapy