Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (Study P03164AM1) (ENCORE)

This study has been completed.
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705614
First received: June 23, 2008
Last updated: March 14, 2013
Last verified: March 2013
  Purpose

Prospective, observational, parallel-group, postmarketing safety surveillance registry in subjects treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD).


Condition Intervention
Crohn's Disease
Biological: Remicade

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence rate (number of subjects with event/total number of subjects at risk x 100) of each adverse event within 7 prespecified categories on the basis of reporting by the subject and/or treating physician. [ Time Frame: after follow-up for up to 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Measures of disease morbidity such as the assessment of overall health status, Harvey-Bradshaw Index, work/daily activity status, fistula status (if any), number and duration of hospitalizations for CD, and the number of surgical procedures for CD. [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 2664
Study Start Date: July 2003
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Remicade Group
Subjects with no prior exposure to Remicade, who at the time of enrollment are scheduled to received Remicade within 30 days of the Baseline Visit.
Biological: Remicade
The treating physician will determine the treatment regimen and dose of Remicade.
Other Names:
  • Infliximab
  • SCH 215596
Standard Therapy Group
Subjects who are being treated with standard therapy and are not adequately maintained and will be offered an alternative treatment that does not include Remicade. Standard therapy subjects must not have previously received Remicade.
Switched to Remicade Group
Subjects who started in the Standard Therapy Group but switched over to Remicade sometime during the follow-up period.
Biological: Remicade
The treating physician will determine the treatment regimen and dose of Remicade.
Other Names:
  • Infliximab
  • SCH 215596

Detailed Description:

This is a prospective, observational, postmarketing safety surveillance registry of CD subjects treated with Remicade or another standard therapy. The follow-up period is up to 5 years. The subjects in the standard therapy group may switch over to Remicade some time during the follow-up period.

  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 active or fistulizing CD with no previous exposure to Remicade will be eligible to enroll into the registry.

Criteria

Inclusion Criteria:

  • At least 18 years of age, of either sex, and of any race.
  • Must have active or fistulizing CD and must have experienced at least 1 of the following:

    • failed a tapering regimen of corticosteroids and will be initiating immunosuppressive therapy
    • required corticosteroid treatments for the previous 6 months and will be initiating immunosuppressive therapy
    • luminal or fistulizing CD, which, in the treating physician's judgment, qualifies for initiation of Remicade.
  • 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) at the Baseline Visit. TB evaluation will consist of TB history questions (eg, medical history, possible previous contact with TB, TB vaccination history). TB evaluation and TB screening (eg, skin test, chest x-ray) are required when a subject starts treatment with Remicade. In these cases, subjects must be screened for TB within 3 months prior to initiating Remicade treatment.

Exclusion Criteria:

  • Female who is pregnant or nursing.
  • Treated with Remicade prior to Baseline.
  • Previously treated with other tumor necrosis factor (TNF)-active agents and other investigational drugs for CD prior to Baseline.
  • Active or untreated latent TB or other severe infections such as sepsis, abscesses, or opportunistic infections.
  • Moderate or severe heart failure (New York Heart Association [NYHA] Class III: subjects with marked limitation of activity; they are comfortable only at rest/Class IV: subjects who should be at complete rest, confined to bed or chair; any physical activity brings on discomfort and symptoms occur at rest).
  • Have lymphoproliferative disorders (eg, lymphoma) or malignancies.
  • In a situation or have any condition that, in the opinion of the treating physician, may interfere with their optimal participation in the registry.
  • Are participating in any other clinical trials (excluding registries).

In addition, subjects will be excluded from treatment with Remicade if any of the criteria listed below are met:

  • Females of childbearing potential unwilling to use a medically accepted method of birth control during treatment with Remicade and to continue its use for at least 6 months after the last Remicade treatment.
  • History of hypersensitivity to murine proteins or to any excipients of Remicade formulation (sucrose, polysorbate 80, monobasic sodium phosphate, and dibasic sodium phosphate).
  • Other conditions that are contraindicated in the Remicade Summary of Product Characteristics (SPC).
  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: Vice President of Late Stage Development, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00705614     History of Changes
Other Study ID Numbers: P03164
Study First Received: June 23, 2008
Last Updated: March 14, 2013
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 22, 2014