N/A
Completed N=320
Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)
Spondylitis, Ankylosing
Source: ClinicalTrials.gov NCT00818168 ↗
Enrolled (actual)
320
Serious AEs
0.6%
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 — 310; 9; 1 participants
Summary
This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness of tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).
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 |
310; 9; 1 | — |
| PRIMARY Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment |
8; 311; 1 | — |
| PRIMARY Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting |
9; 154; 157 | — |
| PRIMARY Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment |
290; 29; 1 | — |
| SECONDARY Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion |
5.15; 5.19 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with ankylosing spondylitis.
Exclusion Criteria
- As per Summary of Product Characteristics (SmPC)
Data sourced from ClinicalTrials.gov (NCT00818168). 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.