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Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00818272
Recruitment Status : Completed
First Posted : January 7, 2009
Results First Posted : February 1, 2012
Last Update Posted : September 3, 2015
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness for tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).

Condition or disease Intervention/treatment
Crohn's Disease Biological: Remicade (infliximab)

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Study Type : Observational
Actual Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Safety Line (Crohn's Disease)
Study Start Date : December 2002
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Infliximab

Group/Cohort Intervention/treatment
Remicade (infliximab)
Participants with confirmed diagnosis of active Crohn's disease.
Biological: Remicade (infliximab)
Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 of infliximab therapy with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
Other Names:
  • Remicade
  • SCH 215596




Primary Outcome Measures :
  1. Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment [ Time Frame: Baseline ]

    In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (tuberculin sensitivity skin test by intradermal injection) as the first screening test was presented in three categories:

    • Yes
    • No
    • Missing (represents no entry, but may mean another test was performed as first screening test and documented)

  2. Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment [ Time Frame: Baseline ]

    In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (multiple puncture tuberculin skin test) as the first screening test was presented in three categories:

    • Yes
    • No
    • Missing (represents no entry, but may mean another test was performed as first screening test and documented)

  3. Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment [ Time Frame: Baseline ]

    In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the in-vitro TB test (cellular blood test, i.e. gamma interferon release assays) as the first screening test was presented in three categories:

    • Yes
    • No
    • Missing (represents no entry, but may mean another test was performed as first screening test and documented)

  4. Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment [ Time Frame: Baseline ]

    In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised a TB screeing test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:

    • Yes
    • No
    • Missing


Secondary Outcome Measures :
  1. Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion [ Time Frame: Baseline and time of first Infusion ]
    The CDAI score is used to quantify the symptoms of participants with CD. The CDAI incorporates 8 items added together that are indicators of disease severity. Scores range from 0 to 600; higher scores indicate worse disease activity. Participants with scores below 150 have inactive disease whereas those with scores above 450 are considered critically ill. A decrease in CDAI over time indicates improvement in disease activity. CDAI was calculated at the time of enrollment (baseline) and at the time of first infusion.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with Crohn's disease.
Criteria

Inclusion Criteria:

  • Subjects with Crohn's disease.

Exclusion Criteria:

  • As per SmPC

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00818272     History of Changes
Other Study ID Numbers: P03288
First Posted: January 7, 2009    Key Record Dates
Results First Posted: February 1, 2012
Last Update Posted: September 3, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents