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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: EUCTR
Last refreshed on: 14 December 2020
Main ID:  EUCTR2015-003759-23-NO
Date of registration: 07/12/2020
Prospective Registration: No
Primary sponsor: AbbVie Deutschland GmbH & Co. KG
Public title: 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
Scientific title: 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: 02/11/2018
Target sample size: 210
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-003759-23
Study type:  Interventional clinical trial of medicinal product
Study design:  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
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Canada Czech Republic Denmark Germany Hungary Israel Netherlands
New Zealand Norway Slovakia Spain United Kingdom United States
Contacts
Name: EU Clinical Trials Helpdesk   
Address:  AbbVie House, Vanwall Business Park, Vanwall Road SL6 4UB Maidenhead, Berkshire United Kingdom
Telephone: +441628561090
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd
Name: EU Clinical Trials Helpdesk   
Address:  AbbVie House, Vanwall Business Park, Vanwall Road SL6 4UB Maidenhead, Berkshire United Kingdom
Telephone: +441628561090
Email: eu-clinical-trials@abbvie.com
Affiliation:  AbbVie Ltd
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Crohn's Disease
MedDRA version: 20.0 Level: LLT Classification code 10013099 Term: Disease Crohns System Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Intervention(s)

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-

Primary Outcome(s)
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.
Secondary Objective: Not applicable
Timepoint(s) of evaluation of this end point: Every 12 months
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
Secondary Outcome(s)
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.
Timepoint(s) of evaluation of this end point: Every 12 months
Secondary ID(s)
M14-327
2015-003759-23-DK
Source(s) of Monetary Support
AbbVie Inc.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 02/11/2018
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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