Clinical trial NCT00705614: Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035)
Official title: Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-26
Enrollment: 2662
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: Prospective, observational, parallel-group, postmarketing safety surveillance registry in participants treated with Remicade or standard therapy for active or fistulizing Crohn's disease (CD). The follow-up period is up to 5 years. The participants in the standard therapy group may switch over to Remicade any time during the follow-up period


Eligibility 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).

Primary outcomes:
measure: Number of Participants With Serious Infections
timeFrame: Up to 5 Years
measure: Number of Participants With Infusion-Related Reactions/Hypersensitivity
timeFrame: Up to 5 Years
measure: Number of Participant Fatalities
timeFrame: Up to 5 Years
measure: Number of Participants With New or Worsening Congestive Heart Failure
timeFrame: Up to 5 Years
measure: Number of Participants With Demyelinating Neurological Disorders
timeFrame: Up to 5 Years
measure: Number of Participants With Hematologic Conditions
timeFrame: Up to 5 Years
measure: Number of Participants With Lymphoproliferative Disorders/Malignancies
timeFrame: Up to 5 Years
Secondary outcomes:
measure: Participant Assessment of Overall Health Status By Study Visit
timeFrame: Up to 5 Years
measure: The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit
timeFrame: Up to 5 Years
measure: Work/Daily Activity Status Score By Study Visit
timeFrame: Up to 5 Years
measure: Number of Participants With a Draining Fistula By Study Visit
timeFrame: Up to 5 Years
measure: Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
timeFrame: Up to 5 Years
measure: Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months
timeFrame: Up to 5 Years
measure: Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months
timeFrame: Up to 5 Years
Other outcomes:
Locations:
Study officials:
References:
citation: D'Haens G, Reinisch W, Colombel JF, Panes J, Ghosh S, Prantera C, Lindgren S, Hommes DW, Huang Z, Boice J, Huyck S, Cornillie F; ENCORE investigators. Five-year Safety Data From ENCORE, a European Observational Safety Registry for Adults With Crohn's Disease Treated With Infliximab [Remicade(R)] or Conventional Therapy. J Crohns Colitis. 2017 Jun 1;11(6):680-689. doi: 10.1093/ecco-jcc/jjw221.