N/A
Completed N=508
Remicade Safety Line (Study P03236)(COMPLETED)
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT00748826 ↗
Enrolled (actual)
508
Serious AEs
0.2%
Results posted
Feb 2012
Primary outcomePrimary: Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment — 481; 26; 1 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment |
481; 26; 1 | — |
| PRIMARY Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment |
23; 484; 1 | — |
| PRIMARY Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment |
6; 216; 286 | — |
| PRIMARY Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment |
459; 48; 1 | — |
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT00748826). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.