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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00818272
Date of registration:	06/01/2009
Prospective Registration:	No
Primary sponsor:	Merck Sharp & Dohme Corp.
Public title:	Remicade Safety Line (Crohn's Disease)(Study P03288)(COMPLETED)
Scientific title:	Remicade Safety Line (Crohn's Disease)
Date of first enrolment:	December 2002
Target sample size:	148
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00818272
Study type:	Observational
Study design:
Phase:	N/A

Countries of recruitment
Germany

Contacts

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subjects with Crohn's disease.

Exclusion Criteria:

- As per SmPC

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Biological: Remicade (infliximab)

Primary Outcome(s)

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]

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]

Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment [Time Frame: Baseline]

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]

Secondary Outcome(s)

Assessment of Disease Activity by Means of the Crohn's Disease Activity Index (CDAI) at the Time of Enrollment and at the First Infusion [Time Frame: Baseline and time of first Infusion]

Secondary ID(s)

P03288

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Centocor, Inc.

Ethics review

Results

Results available:	Yes
Date Posted:	01/02/2012
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00818272

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