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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9 January 2017 |
Main ID: |
EUCTR2016-000674-38-ES |
Date of registration:
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14/12/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Long Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis.
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Scientific title:
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A Phase 3 Multicenter, Open-Label Extension (OLE) Study to Evaluate the Long-Term Safety and Efficacy of ABT-494 in Subjects with Ulcerative Colitis (UC) |
Date of first enrolment:
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16/12/2016 |
Target sample size:
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950 |
Recruitment status: |
Authorised-recruitment may be ongoing or finished |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-000674-38 |
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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Belarus
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Bosnia and Herzegovina
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Brazil
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Canada
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Chile
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China
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Colombia
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Egypt
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Estonia
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European Union
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Greece
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Hungary
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Israel
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Japan
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Kazakhstan
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Korea, Republic of
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Latvia
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Malaysia
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Mexico
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Netherlands
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New Zealand
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Norway
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Puerto Rico
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Russian Federation
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Saudi Arabia
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Serbia
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Singapore
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South Africa
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Spain
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Switzerland
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Taiwan
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Ukraine
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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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34901 2901 20 01 0 |
Email:
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abbvie_reec@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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34901 2901 20 01 0 |
Email:
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abbvie_reec@abbvie.com |
Affiliation:
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AbbVie Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Subject has not responded at the end of the induction period (Week 8) in Study M14-234 (Substudies 1 and 2), who has been an inadequate responder during the maintenance period of Study M14-234 (Substudy 3), or who has responded and successfully completed Study M14-234. 2. If female, subject must meet the criteria as stated in Section 5.2.4 of this protocol: Contraception Recommendations and Pregnancy Testing. 3. Male subjects must agree to follow protocol-specified pregnancy avoidance measures, including refraining from donating sperm, for up to 90 days post last dose of study drug. 4. Subject is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234). 5. Must be able and willing to give written informed consent and to comply with the requirements of this study protocol. 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 800 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria: 1. For any reason subject is considered by the investigator to be an unsuitable candidate. 2. Female subject with a positive pregnancy test at Baseline (final visit of Study M14-234) or who is considering becoming pregnant during the study. 3. Subject with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis MedDRA version: 19.0
Level: PT
Classification code 10009900
Term: Colitis ulcerative
System Organ Class: 10017947 - Gastrointestinal disorders
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Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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Intervention(s)
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Product Name: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: ABT-494 CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15-
Product Name: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: ABT-494 CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30-
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Primary Outcome(s)
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Main Objective: To evaluate the Long-Term Safety and Efficacy of ABT-494
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Secondary Objective: none
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Primary end point(s): The clinical remission or response will be evaluated using the Mayo Scoring System for Assessment of Ulcerative Colitis Activity (Full Mayo score), Adapted Mayo score (Full Mayo score excluding Physician’s Global Assessment), or Partial Mayo score (Full Mayo score excluding endoscopic subscore).
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Timepoint(s) of evaluation of this end point: 288 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: none
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Secondary end point(s): none
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Secondary ID(s)
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2016-000674-38-NL
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M14-533
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Source(s) of Monetary Support
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AbbVie Inc.
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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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