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
  Purpose

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 Intervention
Arthritis, Rheumatoid
Biological: Infliximab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Remicade Safety Line

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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


Enrollment: 576
Study Start Date: August 2002
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

Detailed Description:

This study used a non-probability sampling method.

  Eligibility

Genders Eligible for Study:   Both
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)
  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: NCT00748826     History of Changes
Other Study ID Numbers: P03236
Study First Received: September 5, 2008
Results First Received: December 22, 2011
Last Updated: April 25, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014