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Completed

NCT Number: NCT00705614

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

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

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Remicade

Biological

The treating physician will determine the treatment regimen and dose of Remicade.

Other names: Infliximab, SCH 215596

Primary outcomes

  1. Number of Participants With Serious Infections

    Time frame: Up to 5 Years

    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.

  2. Number of Participants With Infusion-Related Reactions/Hypersensitivity

    Time frame: Up to 5 Years

    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.

  3. Number of Participant Fatalities

    Time frame: Up to 5 Years

    The number of participant fatalities was evaluated throughout the study.

  4. Number of Participants With New or Worsening Congestive Heart Failure

    Time frame: Up to 5 Years

    The number of participants with new or worsening congestive heart failure was evaluated throughout the study.

  5. Number of Participants With Demyelinating Neurological Disorders

    Time frame: Up to 5 Years

    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.

  6. Number of Participants With Hematologic Conditions

    Time frame: Up to 5 Years

    The number of participants wtih hematologic conditions was evaluated. A hematologic condition was defined as thrombocytopenia, neutropenia, pancytopenia, granulocytopenia, leukopenia, or aplastic anemia.

  7. Number of Participants With Lymphoproliferative Disorders/Malignancies

    Time frame: Up to 5 Years

    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 outcomes

  1. Participant Assessment of Overall Health Status By Study Visit

    Time frame: Up to 5 Years

    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.

  2. The Harvey-Bradshaw Index of Crohn's Disease Activity By Study Visit

    Time frame: Up to 5 Years

    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.

  3. Work/Daily Activity Status Score By Study Visit

    Time frame: Up to 5 Years

    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.

  4. Number of Participants With a Draining Fistula By Study Visit

    Time frame: Up to 5 Years

    The number of participants with a draining fistula was evaluated at each study visit.

  5. Number of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months

    Time frame: Up to 5 Years

    The number of participant hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.

  6. Duration of Participant Hospital Stays for Crohn's Disease in the Prior 6 Months

    Time frame: Up to 5 Years

    The duration of hospital stays for Crohn's Disease in the prior 6 months was evaluated at each study visit.

  7. Number of Participant Surgical Procedures for Crohn's Disease in the Prior 6 Months

    Time frame: Up to 5 Years

    The number of participants undergoing surgical procedures for Crohn's Disease in the prior 6 months was evaluated at each study visit.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Crohn's Disease European Registry. A Prospective, Observational, Postmarketing Safety Surveillance Registry of Patients Treated With Remicade® or Standard Therapy

Acronym: ENCORE

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Jun 26, 2008
Registry last updated
Mar 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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