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. |
Register:
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EUCTR |
Last refreshed on:
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14 December 2020 |
Main ID: |
EUCTR2015-003759-23-NO |
Date of registration:
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07/12/2020 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease
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Scientific title:
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A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects with Crohn's Disease |
Date of first enrolment:
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02/11/2018 |
Target sample size:
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210 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003759-23 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Denmark
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Germany
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Hungary
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Israel
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Netherlands
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New Zealand
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Norway
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Slovakia
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Spain
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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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EU Clinical Trials Helpdesk
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Address:
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AbbVie House, Vanwall Business Park, Vanwall Road
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+441628561090 |
Email:
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eu-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Name:
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EU Clinical Trials Helpdesk
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Address:
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AbbVie House, Vanwall Business Park, Vanwall Road
SL6 4UB
Maidenhead, Berkshire
United Kingdom |
Telephone:
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+441628561090 |
Email:
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eu-clinical-trials@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: Subject must have completed Study M13-740 through Week 52. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria: • For any reason subject is considered by the investigator to be an unsuitable candidate • Female subject with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study. • Subject is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Crohn's Disease MedDRA version: 20.0
Level: LLT
Classification code 10013099
Term: Disease Crohns
System Organ Class: 100000004856
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30-
Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-
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Primary Outcome(s)
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Main Objective: To observe the long-term efficacy, safety, and tolerability of repeated administration of upadacitinib in subjects with Crohn's disease (CD) who completed Study M13-740.
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Secondary Objective: Not applicable
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Timepoint(s) of evaluation of this end point: Every 12 months
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Primary end point(s): •Proportion of subjects achieving Remission at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96 •Proportion of subjects in Remission at Week 0 who maintain remission at Months 12, 24, 36, 48, 60, 72, 84, and 96 •Proportion of subjects achieving Response at Week 0 (Week 52 of Study M13-740), Months 12, 24, 36, 48, 60, 72, 84, and 96
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Secondary Outcome(s)
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Secondary end point(s): • Proportion of subjects in Remission, and hs-CRP < 5 mg/L, and fecal calprotectin < 250 µg/g at Week 0 (Week 52 of Study M13-740), Month 12, Month 24, Month 36, Month 48, Month 60, Month 72, Month 84 and Month 96.
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Timepoint(s) of evaluation of this end point: Every 12 months
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Secondary ID(s)
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M14-327
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2015-003759-23-DK
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Source(s) of Monetary Support
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AbbVie Inc.
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Ethics review
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Status: Approved
Approval date: 02/11/2018
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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