European Safety Registry in Ulcerative Colitis (Study P04808AM3)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705484
First received: June 23, 2008
Last updated: September 5, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Ulcerative Colitis
Biological: infliximab
Drug: Standard Therapy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • The incidence (number of subjects with event/total number of subjects in treatment group X 100) of each (serious) adverse event within the nine prespecified categories based on reporting by the subject and/or treating physician. [ Time Frame: Up to 5 years. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2000
Study Start Date: June 2007
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Remicade Group
Subjects 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. Subjects 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
The treating physician will determine the treatment regimen and dose of Remicade.
Other Names:
  • Remicade
  • SCH 215596
Standard Therapy Group
Subjects who are being treated with standard therapy and whose symptoms are not adequately controlled and who are scheduled for an alternative treatment that does not include Remicade. Standard therapy subjects must not have previously received Remicade for UC or any other condition.
Drug: Standard Therapy
The standard therapy group will consist of subjects receiving a treatment regimen that does not include Remicade. The treatment of each standard therapy subject will be left to the discretion of the treating physician and may change during the course of a subject's participation in the registry.
Switched to Remicade Group
Subjects who started in the Standard Therapy Group but switched over to Remicade sometime during the follow-up period.
Biological: infliximab
The treating physician will determine the treatment regimen and dose of Remicade.
Other Names:
  • Remicade
  • SCH 215596
Biological: infliximab
The treating physician will determine the treatment regimen and dose of Remicade.
Other Names:
  • Remicade,
  • SCH 215596

Detailed Description:

This is a prospective, observational, post-marketing safety surveillance registry of UC subjects treated with Remicade or another standard therapy. Registry centers are targeted to enroll a total of 2000 subjects (1000 Remicade subjects and 1000 standard therapy subjects) and to follow them for a period of up to 5 years. Subjects who started the registry on standard therapy may switch over to Remicade.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult subjects, ages 18 years and older, with a diagnosis of moderate-to-severe active UC will be eligible to enroll in the registry.

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 (subjects in this category must be Remicade naïve) or
    • Initiate Remicade. Subjects 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 subjects 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, subjects with conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC) should not be treated with Remicade.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705484     History of Changes
Other Study ID Numbers: P04808
Study First Received: June 23, 2008
Last Updated: September 5, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Ulcer
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathologic Processes
Infliximab
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Gastrointestinal Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014