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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00818168 |
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Date of registration:
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06/01/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Remicade Safety Line (Ankylosing Spondylitis)(Study P03275)(COMPLETED)
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Scientific title:
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Remicade Safety Line (Ankylosing Spondylitis) |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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320 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00818168 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Germany
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects with ankylosing spondylitis.
Exclusion Criteria:
- As per Summary of Product Characteristics (SmPC)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Spondylitis, Ankylosing
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Intervention(s)
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Biological: Infliximab
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Primary Outcome(s)
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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]
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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]
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Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment
[Time Frame: Baseline]
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Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting
[Time Frame: Baseline]
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Secondary Outcome(s)
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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
[Time Frame: Baseline and time of first infusion]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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