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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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12 December 2020 |
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Main ID: |
NCT02185014 |
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Date of registration:
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07/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115
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Scientific title:
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A Multicenter, Open-Label Study to Evaluate the Long Term Efficacy, Safety, and Tolerability of Repeated Administration of Adalimumab in Subjects With Crohn's Disease |
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Date of first enrolment:
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August 12, 2014 |
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Target sample size:
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252 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02185014 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Austria
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Belgium
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Canada
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Czech Republic
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Czechia
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Denmark
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France
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Germany
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Hungary
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Israel
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Italy
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Netherlands
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Poland
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Puerto Rico
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Romania
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Slovakia
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Spain
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Switzerland
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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AbbVie Inc |
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Address:
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Telephone:
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Email:
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Affiliation:
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AbbVie |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the
Week 12 ileocolonoscopy.
Exclusion Criteria:
- If the Week 12 (Study M14-115; NCT02185014) colonoscopy shows evidence of dysplasia or
malignancy.
- Subject is not in compliance with prior and concomitant medication requirements
throughout M14-115 (NCT02185014).
- Subject who developed active Tuberculosis (TB) during M14-115 (NCT02185014), or
subject who is non compliant with prophylaxis for latent tuberculosis (TB) initiated
per M14-115 (NCT02185014) procedures.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Adalimumab
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Primary Outcome(s)
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Percentage of Participants With Endoscopic Improvement at Week 40 in Participants With Endoscopic Improvement at Week 0
[Time Frame: Week 40]
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Secondary ID(s)
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2013-004034-15
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M14-347
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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