Postmarketing Safety Surveillance European Registry of Crohn's Disease Patients Treated With Remicade or Standard Therapy (MK-2155-035) (ENCORE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00705614
First received: June 23, 2008
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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


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:
  • Number of Participants With Serious Infections [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
    The number of participants experiencing serious infections was evaluated. Serious infections included, but were not limited to, tuberculosis, opportunistic infections (such as Pneumocystis carinii [PCP] pneumonia, listeriosis, atypical mycobacteria, and histoplasmosis), salmonellosis,and serious viral infections.

  • Number of Participants With Infusion-Related Reactions/Hypersensitivity [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
    The number of participants with infusion-related reactions and/or hypersensitivity was evaluated. An infuson-related reaction/hypersensitivity was defined as as an acute reaction, including anaphylactic shock that occurs after the onset of the infusion or within the 1- to 2-hour observation period following the end of the infusion. Delayed hypersensitivity reactions (myalgia and/or arthralgia with fever and rash within 14 days of the infusion) were included.

  • Number of Participant Fatalities [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
    The number of participant fatalities was evaluated throughout the study.

  • Number of Participants With New or Worsening Congestive Heart Failure [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
    The number of participants with new or worsening congestive heart failure was evaluated throughout the study.

  • Number of Participants With Demyelinating Neurological Disorders [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
    The number of participants with demyelinating neurological disorders was evaluated. Demyelinating neurological disorders were defined as multiple sclerosis, optic neuritis, peripheral syndromes such as peripheral neuropathy, mononeuropathy multipex, cranial neuropathies, Guillain-Barré syndrome, chronic inflammatory demyelinating polyradiculoneuropathy, and transverse myelitis.

  • Number of Participants With Hematologic Conditions [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
    The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.

  • Number of Participants With Lymphoproliferative Disorders/Malignancies [ Time Frame: Up to 5 Years ] [ Designated as safety issue: Yes ]
    The number of participants wtih lymphoproliferative disorders and/or malignancies was evaluated. A lymphoproliferative disorder and /or malignancy included, but was not limited to, lymphoma, gastrointestinal cancer, skin cancer (including basocellular and squamous carcinoma, melanoma) and in situ cervical carcinoma.


Secondary Outcome Measures:
  • Participant Assessment of Overall Health Status By Study Visit [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    The participant assessment of overall health status was evaluated at baseline and each study visit. The overall health status questionnaire asked participants to rate their current health status over the prior 24 hours as 1=best possible, 2=much better than average, 3=better than average, 4=average, 5=worse than average, 6=much worse than average, or 7=worst possible. Scores ranged from 1 to 7 with lower scores indicating better health status.

  • The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    The Harvey-Bradshaw Index of Crohn's Disease Acitivity was evaluated at each study visit. The Harvey-Bradshaw Index evaluates participants' general health in the day prior in the domains of well being, abdominal pain, number of liquid stools per day, and abdominal mass and complications and was evaluated on the day of the study visit. The score is derived from a 0-4 score for general well being, 0-3 for abdmonial pain, raw score for number of liquid stools per day, 0-3 for abdominal mass, and raw score for complications. The total score is from 0 to infinity, with lower scores indicating better outcomes.

  • Work/Daily Activity Status Score By Study Visit [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    The participant work/daily activity status score was evaluated at each study visit. The work/daily activity questionnaire asked participants to rate their level of daily functioning on a scale of 1 to 10 with a lower score indicating less of an impact of Crohn's disease on work or daily life functioning.

  • Number of Participants With a Draining Fistula By Study Visit [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    The number of participants with a draining fistula was evaluated at each study visit.

  • Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.

  • Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.

  • Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months [ Time Frame: Up to 5 Years ] [ Designated as safety issue: No ]
    The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.


Enrollment: 2662
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
Particpiants with no prior exposure to Remicade, who at the time of enrollment are scheduled to receive Remicade within 30 days of the Baseline Visit. Participants who start on Remicade will constitute the Remicade Group, regardless of whether they continue with Remicade or switch to another treatment.
Biological: Remicade
The treating physician will determine the treatment regimen and dose of Remicade.
Other Names:
  • Infliximab
  • SCH 215596
Standard Therapy Group
Participants 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 participants must not have previously received Remicade.
Switched to Remicade Group
Participants who started in the Standard Therapy Group but switched over to Remicade sometime during the follow-up period. Participants who switch to Remicade are evaluated in the Standard Therapy group until the time of the switch and are evaluated in the Switched to Remicade group thereafter.
Biological: Remicade
The treating physician will determine the treatment regimen and dose of Remicade.
Other Names:
  • Infliximab
  • SCH 215596

  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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00705614     History of Changes
Other Study ID Numbers: P03164
Study First Received: June 23, 2008
Results First Received: February 25, 2014
Last Updated: August 11, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
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 23, 2014