Remicade Safety Line (Study P03236)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00748826
First received: September 5, 2008
Last updated: April 25, 2014
Last verified: April 2014

September 5, 2008
April 25, 2014
August 2002
December 2010   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]

    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
    • No
    • Missing
  • Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment [ Time Frame: Baseline ] [ Designated as safety issue: No ]

    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
    • No
    • Missing
  • 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 ] [ Designated as safety issue: No ]

    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
    • No
    • Missing
  • 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 ] [ Designated as safety issue: No ]

    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
    • No
    • Missing
The intention is to monitor the safety profile of the drug in all patients in routine use of Remicade in RA. [ Time Frame: Ideally after 2 years patient observation ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00748826 on ClinicalTrials.gov Archive Site
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Remicade Safety Line (Study P03236)(COMPLETED)
Remicade Safety Line

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.

This study used a non-probability sampling method.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

The goal is to document all patients in the clinic that meet the inclusion criteria within the scope of the project.

Arthritis, Rheumatoid
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
Infliximab -Rheumatoid Arthritis Participants
Intervention: Biological: Infliximab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
576
December 2010
December 2010   (final data collection date for primary outcome measure)

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)
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00748826
P03236
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP