Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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/NCT03653026




Registration number
NCT03653026
Ethics application status
Date submitted
28/08/2018
Date registered
31/08/2018

Titles & IDs
Public title
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Evaluate the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2016-000642-62
Secondary ID [2] 0 0
M14-675
Universal Trial Number (UTN)
Trial acronym
U-Accomplish
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis (UC) 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

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

Experimental: Upadacitinib 45 mg - Participants received 45 mg upadacitinib once daily (QD) for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 additional weeks in the open-label extension period.

Placebo comparator: Placebo - Participants received placebo matching to upadacitinib once daily for 8 weeks. Participants who did not achieve clinical response per Adapted Mayo score at Week 8 received upadacitinib 45 mg once daily for 8 weeks in the open-label extension period.


Treatment: Drugs: Placebo
Tablet for oral administration

Treatment: Drugs: Upadacitinib
Tablet for oral administration
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [1] 0 0
Percentage of Participants With Endoscopic Improvement at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Percentage of Participants With Endoscopic Remission at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Percentage of Participants Who Achieved Clinical Response Per Adapted Mayo Score at Week 8
Timepoint [3] 0 0
Week 8
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Clinical Response Per Partial Adapted Mayo Score at Week 2
Timepoint [4] 0 0
Week 2
Secondary outcome [5] 0 0
Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Percentage of Participants Who Reported No Bowel Urgency at Week 8
Timepoint [6] 0 0
Week 8
Secondary outcome [7] 0 0
Percentage of Participants Who Reported No Abdominal Pain at Week 8
Timepoint [7] 0 0
Week 8
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved Histologic Improvement at Week 8
Timepoint [8] 0 0
Week 8
Secondary outcome [9] 0 0
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8
Timepoint [9] 0 0
Baseline (Week 0) to Week 8
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved Mucosal Healing at Week 8
Timepoint [10] 0 0
Week 8
Secondary outcome [11] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8
Timepoint [11] 0 0
Baseline (Week 0) to Week 8

Eligibility
Key inclusion criteria
- Male or female participants = 16 and = 75 years of age at Baseline Note: Adolescent participants at the age of 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authorities.

Note: Adolescent participants at the age of 16 or 17 years old must weigh = 40 kilograms and meet the definition of Tanner Stage 5 at the Screening Visit.

* Diagnosis of Ulcerative Colitis (UC) for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.
* Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3.
* Demonstrated an inadequate response, loss of response, or intolerance to at lease one of the following treatments including, oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies.

Note: Participants who have had inadequate response, loss of response to conventional therapy but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease), and must meet criteria for inadequate response, loss of response, or intolerance as defined above.

* Female Participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit.
* If female, participant must meet the contraception recommendation criteria.
Minimum age
16 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC).
* Current diagnosis of fulminant colitis and/or toxic megacolon.
* Participant with disease limited to the rectum (ulcerative proctitis) during the Screening endoscopy.
* Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline.
* Participant who received azathioprine or 6-mercaptopurine (6-MP) within 10 days of Baseline.
* Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.
* Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).
* Screening laboratory and other analyses show any prespecified abnormal hematologic results.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/01/2021
Sample size
Target
Accrual to date
Final
522
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University Hospital /ID# 211955 - Macquarie University
Recruitment hospital [2] 0 0
Duplicate_Mater Misericordiae /ID# 212687 - South Brisbane
Recruitment hospital [3] 0 0
Griffith University /ID# 211956 - Southport
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne /ID# 205758 - Fitzroy
Recruitment hospital [5] 0 0
Monash Medical Centre /ID# 206486 - Melbourne
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 211642 - Murdoch
Recruitment postcode(s) [1] 0 0
2109 - Macquarie University
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
4222 - Southport
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
3168 - Melbourne
Recruitment postcode(s) [6] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Nevada
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
North Dakota
Country [24] 0 0
United States of America
State/province [24] 0 0
Ohio
Country [25] 0 0
United States of America
State/province [25] 0 0
Oklahoma
Country [26] 0 0
United States of America
State/province [26] 0 0
Pennsylvania
Country [27] 0 0
United States of America
State/province [27] 0 0
South Carolina
Country [28] 0 0
United States of America
State/province [28] 0 0
Tennessee
Country [29] 0 0
United States of America
State/province [29] 0 0
Texas
Country [30] 0 0
United States of America
State/province [30] 0 0
Utah
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
United States of America
State/province [33] 0 0
Wisconsin
Country [34] 0 0
Argentina
State/province [34] 0 0
Buenos Aires
Country [35] 0 0
Argentina
State/province [35] 0 0
Ciuadad Autonoma De Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Cordoba
Country [37] 0 0
Austria
State/province [37] 0 0
Wien
Country [38] 0 0
Austria
State/province [38] 0 0
Salzburg
Country [39] 0 0
Belgium
State/province [39] 0 0
Vlaams-Brabant
Country [40] 0 0
Belgium
State/province [40] 0 0
Gent
Country [41] 0 0
Bosnia and Herzegovina
State/province [41] 0 0
Republika Srpska
Country [42] 0 0
Bosnia and Herzegovina
State/province [42] 0 0
Tuzlanski
Country [43] 0 0
Bosnia and Herzegovina
State/province [43] 0 0
Mostar
Country [44] 0 0
Bosnia and Herzegovina
State/province [44] 0 0
Sarajevo
Country [45] 0 0
Brazil
State/province [45] 0 0
Parana
Country [46] 0 0
Brazil
State/province [46] 0 0
Rio Grande Do Sul
Country [47] 0 0
Brazil
State/province [47] 0 0
Sao Paulo
Country [48] 0 0
Canada
State/province [48] 0 0
Alberta
Country [49] 0 0
Canada
State/province [49] 0 0
British Columbia
Country [50] 0 0
Canada
State/province [50] 0 0
Ontario
Country [51] 0 0
Canada
State/province [51] 0 0
Quebec
Country [52] 0 0
Chile
State/province [52] 0 0
Region Metropolitana De Santiago
Country [53] 0 0
Chile
State/province [53] 0 0
Concepción
Country [54] 0 0
Chile
State/province [54] 0 0
Providencia
Country [55] 0 0
Chile
State/province [55] 0 0
Santiago
Country [56] 0 0
China
State/province [56] 0 0
Guangdong
Country [57] 0 0
China
State/province [57] 0 0
Hubei
Country [58] 0 0
China
State/province [58] 0 0
Jiangxi
Country [59] 0 0
China
State/province [59] 0 0
Jilin
Country [60] 0 0
China
State/province [60] 0 0
Shanghai
Country [61] 0 0
China
State/province [61] 0 0
Zhejiang
Country [62] 0 0
China
State/province [62] 0 0
Chengdu
Country [63] 0 0
China
State/province [63] 0 0
Tianjin
Country [64] 0 0
China
State/province [64] 0 0
Wuhan
Country [65] 0 0
Colombia
State/province [65] 0 0
Cordoba
Country [66] 0 0
Colombia
State/province [66] 0 0
Cundinamarca
Country [67] 0 0
Colombia
State/province [67] 0 0
Medellin
Country [68] 0 0
Croatia
State/province [68] 0 0
Grad Zagreb
Country [69] 0 0
Croatia
State/province [69] 0 0
Primorsko-goranska Zupanija
Country [70] 0 0
Croatia
State/province [70] 0 0
Split
Country [71] 0 0
Czechia
State/province [71] 0 0
Hradec Kralove
Country [72] 0 0
Czechia
State/province [72] 0 0
Olomouc
Country [73] 0 0
Czechia
State/province [73] 0 0
Ostrava
Country [74] 0 0
Czechia
State/province [74] 0 0
Pardubice
Country [75] 0 0
Czechia
State/province [75] 0 0
Praha
Country [76] 0 0
Estonia
State/province [76] 0 0
Harjumaa
Country [77] 0 0
Estonia
State/province [77] 0 0
Tallinn
Country [78] 0 0
Estonia
State/province [78] 0 0
Tartu
Country [79] 0 0
Finland
State/province [79] 0 0
Pirkanmaa
Country [80] 0 0
Finland
State/province [80] 0 0
Jyvaskyla
Country [81] 0 0
Finland
State/province [81] 0 0
Mikkeli
Country [82] 0 0
Finland
State/province [82] 0 0
Turku
Country [83] 0 0
France
State/province [83] 0 0
Alpes-Maritimes
Country [84] 0 0
France
State/province [84] 0 0
Rhone
Country [85] 0 0
Germany
State/province [85] 0 0
Baden-Wuerttemberg
Country [86] 0 0
Germany
State/province [86] 0 0
Nordrhein-Westfalen
Country [87] 0 0
Germany
State/province [87] 0 0
Saarland
Country [88] 0 0
Germany
State/province [88] 0 0
Berlin
Country [89] 0 0
Germany
State/province [89] 0 0
Frankfurt am Main
Country [90] 0 0
Germany
State/province [90] 0 0
Kiel
Country [91] 0 0
Germany
State/province [91] 0 0
Muenster
Country [92] 0 0
Greece
State/province [92] 0 0
Attiki
Country [93] 0 0
Greece
State/province [93] 0 0
Kriti
Country [94] 0 0
Greece
State/province [94] 0 0
Athens
Country [95] 0 0
Greece
State/province [95] 0 0
Thessaloniki
Country [96] 0 0
Hungary
State/province [96] 0 0
Bekescsaba
Country [97] 0 0
Hungary
State/province [97] 0 0
Budapest
Country [98] 0 0
Hungary
State/province [98] 0 0
Sopron
Country [99] 0 0
Hungary
State/province [99] 0 0
Szekesfehervar
Country [100] 0 0
Ireland
State/province [100] 0 0
Dublin
Country [101] 0 0
Ireland
State/province [101] 0 0
Galway
Country [102] 0 0
Israel
State/province [102] 0 0
Haifa
Country [103] 0 0
Israel
State/province [103] 0 0
Jerusalem
Country [104] 0 0
Italy
State/province [104] 0 0
Emilia-Romagna
Country [105] 0 0
Italy
State/province [105] 0 0
Milano
Country [106] 0 0
Italy
State/province [106] 0 0
Roma
Country [107] 0 0
Italy
State/province [107] 0 0
Verona
Country [108] 0 0
Italy
State/province [108] 0 0
Milan
Country [109] 0 0
Italy
State/province [109] 0 0
Palermo
Country [110] 0 0
Japan
State/province [110] 0 0
Aichi
Country [111] 0 0
Japan
State/province [111] 0 0
Aomori
Country [112] 0 0
Japan
State/province [112] 0 0
Chiba
Country [113] 0 0
Japan
State/province [113] 0 0
Fukui
Country [114] 0 0
Japan
State/province [114] 0 0
Fukuoka
Country [115] 0 0
Japan
State/province [115] 0 0
Gifu
Country [116] 0 0
Japan
State/province [116] 0 0
Hiroshima
Country [117] 0 0
Japan
State/province [117] 0 0
Hokkaido
Country [118] 0 0
Japan
State/province [118] 0 0
Hyogo
Country [119] 0 0
Japan
State/province [119] 0 0
Ishikawa
Country [120] 0 0
Japan
State/province [120] 0 0
Iwate
Country [121] 0 0
Japan
State/province [121] 0 0
Kagoshima
Country [122] 0 0
Japan
State/province [122] 0 0
Kanagawa
Country [123] 0 0
Japan
State/province [123] 0 0
Kyoto
Country [124] 0 0
Japan
State/province [124] 0 0
Mie
Country [125] 0 0
Japan
State/province [125] 0 0
Miyagi
Country [126] 0 0
Japan
State/province [126] 0 0
Nagasaki
Country [127] 0 0
Japan
State/province [127] 0 0
Nara
Country [128] 0 0
Japan
State/province [128] 0 0
Niigata
Country [129] 0 0
Japan
State/province [129] 0 0
Oita
Country [130] 0 0
Japan
State/province [130] 0 0
Okayama
Country [131] 0 0
Japan
State/province [131] 0 0
Osaka
Country [132] 0 0
Japan
State/province [132] 0 0
Saga
Country [133] 0 0
Japan
State/province [133] 0 0
Saitama
Country [134] 0 0
Japan
State/province [134] 0 0
Shiga
Country [135] 0 0
Japan
State/province [135] 0 0
Shimane
Country [136] 0 0
Japan
State/province [136] 0 0
Shizuoka
Country [137] 0 0
Japan
State/province [137] 0 0
Tokyo
Country [138] 0 0
Japan
State/province [138] 0 0
Yamagata
Country [139] 0 0
Japan
State/province [139] 0 0
Yamaguchi
Country [140] 0 0
Japan
State/province [140] 0 0
Takatsuki-shi
Country [141] 0 0
Korea, Republic of
State/province [141] 0 0
Seoul Teugbyeolsi
Country [142] 0 0
Korea, Republic of
State/province [142] 0 0
Busan
Country [143] 0 0
Korea, Republic of
State/province [143] 0 0
Daegu
Country [144] 0 0
Korea, Republic of
State/province [144] 0 0
Seongnam-si, Gyeonggi-do
Country [145] 0 0
Korea, Republic of
State/province [145] 0 0
Seoul
Country [146] 0 0
Latvia
State/province [146] 0 0
Riga
Country [147] 0 0
Lithuania
State/province [147] 0 0
Kaunas
Country [148] 0 0
Lithuania
State/province [148] 0 0
Klaipeda
Country [149] 0 0
Lithuania
State/province [149] 0 0
Vilnius
Country [150] 0 0
Malaysia
State/province [150] 0 0
Selangor
Country [151] 0 0
Malaysia
State/province [151] 0 0
Kuala Lumpur
Country [152] 0 0
Mexico
State/province [152] 0 0
Guanajuato
Country [153] 0 0
Mexico
State/province [153] 0 0
Jalisco
Country [154] 0 0
Mexico
State/province [154] 0 0
Nuevo Leon
Country [155] 0 0
Netherlands
State/province [155] 0 0
Rotterdam
Country [156] 0 0
Norway
State/province [156] 0 0
Akershus
Country [157] 0 0
Norway
State/province [157] 0 0
Troms
Country [158] 0 0
Poland
State/province [158] 0 0
Kujawsko-pomorskie
Country [159] 0 0
Poland
State/province [159] 0 0
Mazowieckie
Country [160] 0 0
Poland
State/province [160] 0 0
Pomorskie
Country [161] 0 0
Portugal
State/province [161] 0 0
Braga
Country [162] 0 0
Portugal
State/province [162] 0 0
Porto
Country [163] 0 0
Portugal
State/province [163] 0 0
Viana Do Castelo
Country [164] 0 0
Portugal
State/province [164] 0 0
Almada
Country [165] 0 0
Portugal
State/province [165] 0 0
Lisboa
Country [166] 0 0
Portugal
State/province [166] 0 0
Lisbon
Country [167] 0 0
Puerto Rico
State/province [167] 0 0
San Juan
Country [168] 0 0
Russian Federation
State/province [168] 0 0
Kaliningradskaya Oblast
Country [169] 0 0
Russian Federation
State/province [169] 0 0
Leningradskaya Oblast
Country [170] 0 0
Russian Federation
State/province [170] 0 0
Permskiy Kray
Country [171] 0 0
Russian Federation
State/province [171] 0 0
Samarskaya Oblast
Country [172] 0 0
Russian Federation
State/province [172] 0 0
Stavropol Skiy Kray
Country [173] 0 0
Russian Federation
State/province [173] 0 0
Tatarstan, Respublika
Country [174] 0 0
Russian Federation
State/province [174] 0 0
Moscow
Country [175] 0 0
Russian Federation
State/province [175] 0 0
Petrozavodsk
Country [176] 0 0
Russian Federation
State/province [176] 0 0
Pushkin
Country [177] 0 0
Russian Federation
State/province [177] 0 0
Pyatigorsk
Country [178] 0 0
Serbia
State/province [178] 0 0
Beograd
Country [179] 0 0
Serbia
State/province [179] 0 0
Nisavski Okrug
Country [180] 0 0
Serbia
State/province [180] 0 0
Sumadijski Okrug
Country [181] 0 0
Serbia
State/province [181] 0 0
Vojvodina
Country [182] 0 0
Serbia
State/province [182] 0 0
Leskovac
Country [183] 0 0
Singapore
State/province [183] 0 0
Singapore
Country [184] 0 0
Slovakia
State/province [184] 0 0
Bratislavsky Kraj
Country [185] 0 0
Slovakia
State/province [185] 0 0
Banska Bystrica
Country [186] 0 0
Slovakia
State/province [186] 0 0
Kosice
Country [187] 0 0
Slovakia
State/province [187] 0 0
Nove Zamky
Country [188] 0 0
Slovakia
State/province [188] 0 0
Presov
Country [189] 0 0
South Africa
State/province [189] 0 0
Gauteng
Country [190] 0 0
South Africa
State/province [190] 0 0
Western Cape
Country [191] 0 0
Spain
State/province [191] 0 0
A Coruna
Country [192] 0 0
Spain
State/province [192] 0 0
Cantabria
Country [193] 0 0
Spain
State/province [193] 0 0
Las Palmas
Country [194] 0 0
Spain
State/province [194] 0 0
Barcelona
Country [195] 0 0
Spain
State/province [195] 0 0
Cordoba
Country [196] 0 0
Spain
State/province [196] 0 0
Madrid
Country [197] 0 0
Spain
State/province [197] 0 0
Salamanca
Country [198] 0 0
Spain
State/province [198] 0 0
Valencia
Country [199] 0 0
Switzerland
State/province [199] 0 0
Sankt Gallen
Country [200] 0 0
Switzerland
State/province [200] 0 0
Basel
Country [201] 0 0
Switzerland
State/province [201] 0 0
Bern
Country [202] 0 0
Switzerland
State/province [202] 0 0
Zurich
Country [203] 0 0
Taiwan
State/province [203] 0 0
Taichung
Country [204] 0 0
Taiwan
State/province [204] 0 0
Taipei
Country [205] 0 0
Taiwan
State/province [205] 0 0
Kaohsiung
Country [206] 0 0
Taiwan
State/province [206] 0 0
Taipei City
Country [207] 0 0
Turkey
State/province [207] 0 0
Kayseri
Country [208] 0 0
Turkey
State/province [208] 0 0
Ankara GAZI
Country [209] 0 0
Turkey
State/province [209] 0 0
Istanbul
Country [210] 0 0
Turkey
State/province [210] 0 0
Mersin
Country [211] 0 0
Ukraine
State/province [211] 0 0
Kharkivska Oblast
Country [212] 0 0
Ukraine
State/province [212] 0 0
Kyivska Oblast
Country [213] 0 0
Ukraine
State/province [213] 0 0
Kropyvnytskyi
Country [214] 0 0
Ukraine
State/province [214] 0 0
Kyiv
Country [215] 0 0
Ukraine
State/province [215] 0 0
Vinnytsia
Country [216] 0 0
United Kingdom
State/province [216] 0 0
Basingstoke
Country [217] 0 0
United Kingdom
State/province [217] 0 0
Glasgow
Country [218] 0 0
United Kingdom
State/province [218] 0 0
Huddersfield
Country [219] 0 0
United Kingdom
State/province [219] 0 0
London
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Whitechapel

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 and 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)
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
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 (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
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?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03653026