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Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Remicade (infliximab) (Biological)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

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 for tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).

Clinical Details

Official title: Remicade Safety Line (Crohn's Disease)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment

Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment

Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment

Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment

Secondary outcome: Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Subjects with Crohn's disease.

Exclusion Criteria:

- As per SmPC

Locations and Contacts

Additional Information

Starting date: December 2002
Last updated: October 27, 2014

Page last updated: August 23, 2015

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