Remicade Safety Line (Study P03236)(COMPLETED)

• 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: Merck Sharp & Dohme Corp.
• Information provided by (Responsible Party): Merck Sharp & Dohme Corp.

Study Description

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 Design

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

Groups and Cohorts

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

Outcome Measures

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
   • No
   • 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
   • No
   • 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
   • No
   • 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
   • No
   • Missing

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• 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)

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Merck Sharp & Dohme Corp.
• ClinicalTrials.gov Identifier: NCT00748826
• Other Study ID Numbers: P03236
• First Posted: September 9, 2008
• 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