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Remicade Safety Line (Study P03236)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00748826
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : February 1, 2012
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The goal of this study is to implement instruments that would increase the treating physician's awareness of the necessary tuberculosis screening when starting a new patient on infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying preparations, including methotrexate.

Condition or disease Intervention/treatment
Arthritis, Rheumatoid Biological: Infliximab

Detailed Description:
This study used a non-probability sampling method.

Study Type : Observational
Actual Enrollment : 576 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Safety Line
Study Start Date : August 2002
Primary Completion Date : December 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Group/Cohort Intervention/treatment
Infliximab -Rheumatoid Arthritis Participants Biological: Infliximab

Patients with active rheumatoid arthritis (RA) confirmed with American College of Rheumatology (ACR) criteria could take part in the project if they did not respond sufficiently to disease-modifying products, including methotrexate, 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

Other Name: Remicade



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) per clinical testing as the first screening test was presented in

    three categories:

    • Yes
    • Missing

  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) per clinical testing as the first screening test was presented in three categories:

    • Yes
    • Missing

  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) per clinical testing as the first screening test was presented in three categories:

    • Yes
    • Missing

  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 of a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories:

    • Yes
    • Missing



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The goal is to document all patients in the clinic that meet the inclusion criteria within the scope of the project.
Criteria

Inclusion Criteria:

  • Patients with active rheumatoid arthritis confirmed with adequate clinical response(ACR) criteria who did not react sufficiently to disease-modifying preparations, including methotrexate, and who are receiving new treatment with infliximab.

Exclusion Criteria:

  • As per Summary of Product Characteristics (SmPC)

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00748826     History of Changes
Other Study ID Numbers: P03236
First Posted: September 9, 2008    Key Record Dates
Results First Posted: February 1, 2012
Last Update Posted: September 3, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents