Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02782663




Registration number
NCT02782663
Ethics application status
Date submitted
23/05/2016
Date registered
25/05/2016

Titles & IDs
Public title
A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants 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
Secondary ID [1] 0 0
2015-003759-23
Secondary ID [2] 0 0
M14-327
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease (CD) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABT-494

Experimental: Upadacitinib (ABT-494) Dose A - Open label dose A once daily (QD)

Experimental: Upadacitinib (ABT-494) Dose B - Open label dose B QD


Treatment: Drugs: ABT-494
Tablet: Oral
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Achieving Remission
Timepoint [1] 0 0
Up to Month 96
Primary outcome [2] 0 0
Percentage of Participants in Remission at Week 0 Who Maintain Remission
Timepoint [2] 0 0
Up to Month 96
Primary outcome [3] 0 0
Percentage of Participants Achieving Response
Timepoint [3] 0 0
Up to Month 96
Primary outcome [4] 0 0
Percentage of Participants Achieving Clinical Remission
Timepoint [4] 0 0
Up to Month 96
Primary outcome [5] 0 0
Percentage of Participants Achieving Modified Clinical Remission
Timepoint [5] 0 0
Up to Month 96
Primary outcome [6] 0 0
Percentage of Participants Achieving Enhanced Clinical Response
Timepoint [6] 0 0
Up to Month 96
Primary outcome [7] 0 0
Percentage of Participants Achieving Clinical Response
Timepoint [7] 0 0
Up to Month 96
Primary outcome [8] 0 0
Percentage of Participants Achieving Endoscopic Remission
Timepoint [8] 0 0
Up to Month 96
Primary outcome [9] 0 0
Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission
Timepoint [9] 0 0
Up to Month 96
Primary outcome [10] 0 0
Percentage of Participants Achieving Endoscopic Improvement
Timepoint [10] 0 0
Up to Month 96
Primary outcome [11] 0 0
Percentage of Participants Achieving Endoscopic Response
Timepoint [11] 0 0
Up to Month 96
Primary outcome [12] 0 0
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission
Timepoint [12] 0 0
Up to Month 96
Primary outcome [13] 0 0
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response
Timepoint [13] 0 0
Up to Month 96
Primary outcome [14] 0 0
Percentage of Participants Achieving Enhanced CDAI Response
Timepoint [14] 0 0
Up to Month 96
Primary outcome [15] 0 0
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
Timepoint [15] 0 0
Up to Month 96
Primary outcome [16] 0 0
Percentage of Participants Achieving IBDQ Response
Timepoint [16] 0 0
Up to Month 96
Primary outcome [17] 0 0
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free
Timepoint [17] 0 0
Up to Month 96
Primary outcome [18] 0 0
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission
Timepoint [18] 0 0
Up to Month 96
Primary outcome [19] 0 0
Percentage of Participants Achieving Remission and Normal C-Reactive Protein
Timepoint [19] 0 0
Up to Month 96

Eligibility
Key inclusion criteria
* Participant must have completed Study M13-740 through Week 52.
* If female, participant must be postmenopausal, surgically sterile or on using a birth control method.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* For any reason participant is considered by the investigator to be an unsuitable candidate
* Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
* Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
17/09/2025
Actual
Sample size
Target
Accrual to date
Final
107
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Kentucky
Country [6] 0 0
United States of America
State/province [6] 0 0
Maryland
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Oklahoma
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
United States of America
State/province [18] 0 0
Wisconsin
Country [19] 0 0
Belgium
State/province [19] 0 0
Liege
Country [20] 0 0
Canada
State/province [20] 0 0
Alberta
Country [21] 0 0
Canada
State/province [21] 0 0
British Columbia
Country [22] 0 0
Canada
State/province [22] 0 0
Ontario
Country [23] 0 0
Canada
State/province [23] 0 0
Quebec
Country [24] 0 0
Czechia
State/province [24] 0 0
Hradec Kralove
Country [25] 0 0
Denmark
State/province [25] 0 0
Hovedstaden
Country [26] 0 0
Denmark
State/province [26] 0 0
Midtjylland
Country [27] 0 0
France
State/province [27] 0 0
Meurthe-et-Moselle
Country [28] 0 0
France
State/province [28] 0 0
Nord
Country [29] 0 0
France
State/province [29] 0 0
Somme
Country [30] 0 0
Germany
State/province [30] 0 0
Schleswig-Holstein
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin
Country [32] 0 0
Germany
State/province [32] 0 0
Muenster
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Israel
State/province [34] 0 0
HaMerkaz
Country [35] 0 0
Israel
State/province [35] 0 0
Tel-Aviv
Country [36] 0 0
Israel
State/province [36] 0 0
Haifa
Country [37] 0 0
Italy
State/province [37] 0 0
Calabria
Country [38] 0 0
Italy
State/province [38] 0 0
Bologna
Country [39] 0 0
Netherlands
State/province [39] 0 0
Noord-Holland
Country [40] 0 0
Netherlands
State/province [40] 0 0
Utrecht
Country [41] 0 0
New Zealand
State/province [41] 0 0
Otago
Country [42] 0 0
Norway
State/province [42] 0 0
Oslo
Country [43] 0 0
Poland
State/province [43] 0 0
Lodzkie
Country [44] 0 0
Poland
State/province [44] 0 0
Mazowieckie
Country [45] 0 0
Romania
State/province [45] 0 0
Timi?oara
Country [46] 0 0
Slovakia
State/province [46] 0 0
Nitriansky Kraj
Country [47] 0 0
Slovakia
State/province [47] 0 0
Presovsky Kraj
Country [48] 0 0
Spain
State/province [48] 0 0
A Coruna
Country [49] 0 0
Spain
State/province [49] 0 0
Madrid
Country [50] 0 0
United Kingdom
State/province [50] 0 0
Oxfordshire
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR), Analytic code
When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02782663