Register a trial

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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/NCT03345823




Registration number
NCT03345823
Ethics application status
Date submitted
15/11/2017
Date registered
17/11/2017

Titles & IDs
Public title
A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Crohn's Disease Who Completed the Studies M14-431 or M14-433
Secondary ID [1] 0 0
2023-504951-29
Secondary ID [2] 0 0
M14-430
Universal Trial Number (UTN)
Trial acronym
U-ENDURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 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 - Upadacitinib
Treatment: Drugs - Placebo for Upadacitinib

Experimental: Substudy 1: Cohort 1 Upadacitinib Dose A - This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose A for 52 weeks.

Experimental: Substudy 1: Cohort 1 Upadacitinib Dose B - This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive upadacitinib dose B for 52 weeks.

Experimental: Substudy 1: Cohort 1 Placebo - This is a maintenance group which includes participants who achieved clinical response to upadacitinib in studies M14-431 and M14-433 and will receive placebo for 52 weeks.

Experimental: Substudy 1: Cohort 2 Placebo - This is a maintenance group which includes participants who received double-blind placebo in studies M14-431 and M14-433 and achieved clinical response will continue to receive blinded placebo for 52 Weeks.

Experimental: Substudy 1: Cohort 3 Upadacitinib Dose B - This is a maintenance group which includes participants who achieved clinical response to upadacitinib from the extended treatment period of studies M14-431 and M14-433 and will receive upadacitinib Dose B for 52 Weeks.

Experimental: Substudy 2: Cohort 4 Upadacitinib Dose B - This is a long-term extension group which includes participants who achieved clinical response in the open-label extended treatment period of study M14-431 and will receive upadacitinib dose B for 240 weeks.

Experimental: Substudy 2: Cohort 5 Upadacitinib Dose A - This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose A for 240 weeks.

Experimental: Substudy 2: Cohort 5 Upadacitinib Dose B - This is a long-term extension group which includes participants who complete Substudy 1 and will receive upadacitinib dose B for 240 weeks.

Experimental: Substudy 2: Cohort 5 Placebo - This is a long-term extension group which includes participants who complete Substudy 1 and will receive placebo for 240 weeks.


Treatment: Drugs: Upadacitinib
Oral; Tablet

Treatment: Drugs: Placebo for Upadacitinib
Oral; Tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Crohn's Disease Activity Index (CDAI)
Timepoint [1] 0 0
Week 52
Primary outcome [2] 0 0
Sub-Study 1: Percentage of Participants with Endoscopic Response
Timepoint [2] 0 0
Week 52
Primary outcome [3] 0 0
Number of Participants with Adverse Events
Timepoint [3] 0 0
Through Week 240
Secondary outcome [1] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per Patient-Reported Outcomes (PROs)
Timepoint [1] 0 0
Week 52
Secondary outcome [2] 0 0
Sub-Study 1: Percentage of Participants Achieving Clinical Response 100 (CR-100)
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Sub-Study 1: Percentage of Participants with Endoscopic Remission
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Sub-Study 1: Percentage of Participants without Corticosteroid use for Crohn's Disease Among All Participants
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI and Endoscopic Remission
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Sub-Study 1: Percentage of Participants with Clinical Remission per CDAI
Timepoint [6] 0 0
Through Week 52
Secondary outcome [7] 0 0
Sub-Study 1: Percentage of Participants who Discontinue Corticosteroid Use for Crohn's Disease at Least 90 Days Prior to Week 52 and Achieve Clinical Remission, in Participants Taking Corticosteroids at Baseline.
Timepoint [7] 0 0
Week 52
Secondary outcome [8] 0 0
Sub-Study 1: Change in Inflammatory Bowel Disease Questionnaire (IBDQ)
Timepoint [8] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [9] 0 0
Sub-Study 1: Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Timepoint [9] 0 0
Baseline (Week 0) to Week 52
Secondary outcome [10] 0 0
Sub-Study 1: Percentage of Participants with Hospitalizations due to Crohn's Disease (CD)
Timepoint [10] 0 0
Up to Week 52
Secondary outcome [11] 0 0
Sub-Study 1: Percentage of Participants with Resolution of Extra-Intestinal Manifestation (EIMs) , in Participants with EIMs at Baseline
Timepoint [11] 0 0
Week 52

Eligibility
Key inclusion criteria
For Substudy 1:

* Participant who achieve clinical response in Study M14-431 or Study M14-433.
* Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.

For Substudy 2:

* Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic.
* Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
For Substudies 1 and 2:

* Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
* Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study.
* Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment.
* Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).

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
Other
Other design features
Phase
Phase 3
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
21/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/09/2027
Actual
Sample size
Target
747
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital /ID# 171506 - Concord
Recruitment hospital [2] 0 0
Coral Sea Clinical Research institute /ID# 212989 - North Mackay
Recruitment hospital [3] 0 0
Mater Misericordiae Limited /ID# 204910 - South Brisbane
Recruitment hospital [4] 0 0
Royal Adelaide Hospital /ID# 171508 - Adelaide
Recruitment hospital [5] 0 0
Box Hill Hospital /ID# 203735 - Box Hill
Recruitment hospital [6] 0 0
Fiona Stanley Hospital /ID# 171507 - Murdoch
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
4740 - North Mackay
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
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
Idaho
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Iowa
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
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Minnesota
Country [18] 0 0
United States of America
State/province [18] 0 0
Mississippi
Country [19] 0 0
United States of America
State/province [19] 0 0
Nebraska
Country [20] 0 0
United States of America
State/province [20] 0 0
Nevada
Country [21] 0 0
United States of America
State/province [21] 0 0
New Jersey
Country [22] 0 0
United States of America
State/province [22] 0 0
New York
Country [23] 0 0
United States of America
State/province [23] 0 0
North Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
North Dakota
Country [25] 0 0
United States of America
State/province [25] 0 0
Ohio
Country [26] 0 0
United States of America
State/province [26] 0 0
Oklahoma
Country [27] 0 0
United States of America
State/province [27] 0 0
Pennsylvania
Country [28] 0 0
United States of America
State/province [28] 0 0
South Carolina
Country [29] 0 0
United States of America
State/province [29] 0 0
South Dakota
Country [30] 0 0
United States of America
State/province [30] 0 0
Tennessee
Country [31] 0 0
United States of America
State/province [31] 0 0
Texas
Country [32] 0 0
United States of America
State/province [32] 0 0
Utah
Country [33] 0 0
United States of America
State/province [33] 0 0
Washington
Country [34] 0 0
United States of America
State/province [34] 0 0
Wisconsin
Country [35] 0 0
Argentina
State/province [35] 0 0
Buenos Aires
Country [36] 0 0
Argentina
State/province [36] 0 0
Ciudad Autonoma De Buenos Aires
Country [37] 0 0
Argentina
State/province [37] 0 0
Santa Fe
Country [38] 0 0
Argentina
State/province [38] 0 0
Cordoba
Country [39] 0 0
Austria
State/province [39] 0 0
Wien
Country [40] 0 0
Austria
State/province [40] 0 0
Salzburg
Country [41] 0 0
Belgium
State/province [41] 0 0
Bruxelles-Capitale
Country [42] 0 0
Belgium
State/province [42] 0 0
Liege
Country [43] 0 0
Belgium
State/province [43] 0 0
Namur
Country [44] 0 0
Belgium
State/province [44] 0 0
Oost-Vlaanderen
Country [45] 0 0
Belgium
State/province [45] 0 0
Vlaams-Brabant
Country [46] 0 0
Bosnia and Herzegovina
State/province [46] 0 0
Republika Srpska
Country [47] 0 0
Bosnia and Herzegovina
State/province [47] 0 0
Tuzlanski
Country [48] 0 0
Bosnia and Herzegovina
State/province [48] 0 0
Sarajevo
Country [49] 0 0
Brazil
State/province [49] 0 0
Goias
Country [50] 0 0
Brazil
State/province [50] 0 0
La Spezia
Country [51] 0 0
Brazil
State/province [51] 0 0
Parana
Country [52] 0 0
Brazil
State/province [52] 0 0
Rio Grande Do Sul
Country [53] 0 0
Brazil
State/province [53] 0 0
Sao Paulo
Country [54] 0 0
Bulgaria
State/province [54] 0 0
Plovdiv
Country [55] 0 0
Bulgaria
State/province [55] 0 0
Sofia
Country [56] 0 0
Bulgaria
State/province [56] 0 0
Stara Zagora
Country [57] 0 0
Canada
State/province [57] 0 0
Alberta
Country [58] 0 0
Canada
State/province [58] 0 0
British Columbia
Country [59] 0 0
Canada
State/province [59] 0 0
Nova Scotia
Country [60] 0 0
Canada
State/province [60] 0 0
Ontario
Country [61] 0 0
Canada
State/province [61] 0 0
Quebec
Country [62] 0 0
Chile
State/province [62] 0 0
Region Metropolitana De Santiago
Country [63] 0 0
Chile
State/province [63] 0 0
Concepción
Country [64] 0 0
Chile
State/province [64] 0 0
Providencia
Country [65] 0 0
Chile
State/province [65] 0 0
Santiago
Country [66] 0 0
Chile
State/province [66] 0 0
Ñuñoa
Country [67] 0 0
China
State/province [67] 0 0
Beijing
Country [68] 0 0
China
State/province [68] 0 0
Fujian
Country [69] 0 0
China
State/province [69] 0 0
Guangdong
Country [70] 0 0
China
State/province [70] 0 0
Hubei
Country [71] 0 0
China
State/province [71] 0 0
Jiangsu
Country [72] 0 0
China
State/province [72] 0 0
Jiangxi
Country [73] 0 0
China
State/province [73] 0 0
Jilin
Country [74] 0 0
China
State/province [74] 0 0
Shanghai
Country [75] 0 0
China
State/province [75] 0 0
Zhejiang
Country [76] 0 0
China
State/province [76] 0 0
Changsha
Country [77] 0 0
China
State/province [77] 0 0
Tianjin
Country [78] 0 0
Colombia
State/province [78] 0 0
Antioquia
Country [79] 0 0
Croatia
State/province [79] 0 0
Grad Zagreb
Country [80] 0 0
Croatia
State/province [80] 0 0
Split
Country [81] 0 0
Croatia
State/province [81] 0 0
Zadar
Country [82] 0 0
Czechia
State/province [82] 0 0
Ceske Budejovice
Country [83] 0 0
Czechia
State/province [83] 0 0
Hradec Kralove
Country [84] 0 0
Czechia
State/province [84] 0 0
Ostrava
Country [85] 0 0
Czechia
State/province [85] 0 0
Praha
Country [86] 0 0
Denmark
State/province [86] 0 0
Hovedstaden
Country [87] 0 0
Denmark
State/province [87] 0 0
Sjælland
Country [88] 0 0
Egypt
State/province [88] 0 0
Alexandria
Country [89] 0 0
Egypt
State/province [89] 0 0
Cairo
Country [90] 0 0
Egypt
State/province [90] 0 0
Menoufiya
Country [91] 0 0
Estonia
State/province [91] 0 0
Tartumaa
Country [92] 0 0
Estonia
State/province [92] 0 0
Tallinn
Country [93] 0 0
France
State/province [93] 0 0
Alpes-Maritimes
Country [94] 0 0
France
State/province [94] 0 0
Gironde
Country [95] 0 0
France
State/province [95] 0 0
Haute-Garonne
Country [96] 0 0
France
State/province [96] 0 0
Herault
Country [97] 0 0
France
State/province [97] 0 0
Ile-de-France
Country [98] 0 0
France
State/province [98] 0 0
Isere
Country [99] 0 0
France
State/province [99] 0 0
Meurthe-et-Moselle
Country [100] 0 0
France
State/province [100] 0 0
Nord
Country [101] 0 0
France
State/province [101] 0 0
Rhone
Country [102] 0 0
France
State/province [102] 0 0
Somme
Country [103] 0 0
France
State/province [103] 0 0
Chambray Les Tours
Country [104] 0 0
France
State/province [104] 0 0
Creteil
Country [105] 0 0
France
State/province [105] 0 0
Nantes
Country [106] 0 0
France
State/province [106] 0 0
Nimes Cedex
Country [107] 0 0
France
State/province [107] 0 0
St-Priest-en-Jarez
Country [108] 0 0
Germany
State/province [108] 0 0
Baden-Wuerttemberg
Country [109] 0 0
Germany
State/province [109] 0 0
Bayern
Country [110] 0 0
Germany
State/province [110] 0 0
Hessen
Country [111] 0 0
Germany
State/province [111] 0 0
Saarland
Country [112] 0 0
Germany
State/province [112] 0 0
Schleswig-Holstein
Country [113] 0 0
Germany
State/province [113] 0 0
Berlin
Country [114] 0 0
Germany
State/province [114] 0 0
Essen
Country [115] 0 0
Germany
State/province [115] 0 0
Halle (Saale)
Country [116] 0 0
Germany
State/province [116] 0 0
Muenster
Country [117] 0 0
Greece
State/province [117] 0 0
Attiki
Country [118] 0 0
Greece
State/province [118] 0 0
Kriti
Country [119] 0 0
Greece
State/province [119] 0 0
Athens
Country [120] 0 0
Greece
State/province [120] 0 0
Thessaloniki
Country [121] 0 0
Hong Kong
State/province [121] 0 0
Hong Kong
Country [122] 0 0
Hungary
State/province [122] 0 0
Baranya
Country [123] 0 0
Hungary
State/province [123] 0 0
Borsod-Abauj-Zemplen
Country [124] 0 0
Hungary
State/province [124] 0 0
Hajdu-Bihar
Country [125] 0 0
Hungary
State/province [125] 0 0
Heves
Country [126] 0 0
Hungary
State/province [126] 0 0
Komarom-Esztergom
Country [127] 0 0
Hungary
State/province [127] 0 0
Budapest
Country [128] 0 0
Hungary
State/province [128] 0 0
Debrecen
Country [129] 0 0
Hungary
State/province [129] 0 0
Kistarcsa
Country [130] 0 0
Hungary
State/province [130] 0 0
Szekesfehervar
Country [131] 0 0
Ireland
State/province [131] 0 0
Cork
Country [132] 0 0
Israel
State/province [132] 0 0
HaDarom
Country [133] 0 0
Israel
State/province [133] 0 0
HaMerkaz
Country [134] 0 0
Israel
State/province [134] 0 0
Tel-Aviv
Country [135] 0 0
Israel
State/province [135] 0 0
Yerushalayim
Country [136] 0 0
Israel
State/province [136] 0 0
Haifa
Country [137] 0 0
Italy
State/province [137] 0 0
Calabria
Country [138] 0 0
Italy
State/province [138] 0 0
Lazio
Country [139] 0 0
Italy
State/province [139] 0 0
Milano
Country [140] 0 0
Italy
State/province [140] 0 0
Roma
Country [141] 0 0
Italy
State/province [141] 0 0
Verona
Country [142] 0 0
Italy
State/province [142] 0 0
Bologna
Country [143] 0 0
Italy
State/province [143] 0 0
Catania
Country [144] 0 0
Italy
State/province [144] 0 0
Genova
Country [145] 0 0
Italy
State/province [145] 0 0
Modena
Country [146] 0 0
Italy
State/province [146] 0 0
Palermo
Country [147] 0 0
Italy
State/province [147] 0 0
Pisa
Country [148] 0 0
Japan
State/province [148] 0 0
Aichi
Country [149] 0 0
Japan
State/province [149] 0 0
Aomori
Country [150] 0 0
Japan
State/province [150] 0 0
Chiba
Country [151] 0 0
Japan
State/province [151] 0 0
Fukuoka
Country [152] 0 0
Japan
State/province [152] 0 0
Gunma
Country [153] 0 0
Japan
State/province [153] 0 0
Hiroshima
Country [154] 0 0
Japan
State/province [154] 0 0
Hokkaido
Country [155] 0 0
Japan
State/province [155] 0 0
Hyogo
Country [156] 0 0
Japan
State/province [156] 0 0
Ishikawa
Country [157] 0 0
Japan
State/province [157] 0 0
Iwate
Country [158] 0 0
Japan
State/province [158] 0 0
Kagoshima
Country [159] 0 0
Japan
State/province [159] 0 0
Kanagawa
Country [160] 0 0
Japan
State/province [160] 0 0
Kyoto
Country [161] 0 0
Japan
State/province [161] 0 0
Mie
Country [162] 0 0
Japan
State/province [162] 0 0
Miyagi
Country [163] 0 0
Japan
State/province [163] 0 0
Nara
Country [164] 0 0
Japan
State/province [164] 0 0
Niigata
Country [165] 0 0
Japan
State/province [165] 0 0
Oita
Country [166] 0 0
Japan
State/province [166] 0 0
Okayama
Country [167] 0 0
Japan
State/province [167] 0 0
Osaka
Country [168] 0 0
Japan
State/province [168] 0 0
Saitama
Country [169] 0 0
Japan
State/province [169] 0 0
Shiga
Country [170] 0 0
Japan
State/province [170] 0 0
Shizuoka
Country [171] 0 0
Japan
State/province [171] 0 0
Tokyo
Country [172] 0 0
Japan
State/province [172] 0 0
Toyama
Country [173] 0 0
Japan
State/province [173] 0 0
Wakayama
Country [174] 0 0
Japan
State/province [174] 0 0
Yamagata
Country [175] 0 0
Japan
State/province [175] 0 0
Mitaka
Country [176] 0 0
Korea, Republic of
State/province [176] 0 0
Daegu Gwang Yeogsi
Country [177] 0 0
Korea, Republic of
State/province [177] 0 0
Gyeonggido
Country [178] 0 0
Korea, Republic of
State/province [178] 0 0
Gyeongsangnamdo
Country [179] 0 0
Korea, Republic of
State/province [179] 0 0
Seoul Teugbyeolsi
Country [180] 0 0
Korea, Republic of
State/province [180] 0 0
Busan
Country [181] 0 0
Korea, Republic of
State/province [181] 0 0
Seoul
Country [182] 0 0
Latvia
State/province [182] 0 0
Riga
Country [183] 0 0
Lithuania
State/province [183] 0 0
Kaunas
Country [184] 0 0
Lithuania
State/province [184] 0 0
Vilnius
Country [185] 0 0
Malaysia
State/province [185] 0 0
Kedah
Country [186] 0 0
Malaysia
State/province [186] 0 0
Selangor
Country [187] 0 0
Malaysia
State/province [187] 0 0
Kelantan
Country [188] 0 0
Mexico
State/province [188] 0 0
Durango
Country [189] 0 0
Mexico
State/province [189] 0 0
Guanajuato
Country [190] 0 0
Mexico
State/province [190] 0 0
Jalisco
Country [191] 0 0
Netherlands
State/province [191] 0 0
Gelderland
Country [192] 0 0
Netherlands
State/province [192] 0 0
Limburg
Country [193] 0 0
Netherlands
State/province [193] 0 0
Amsterdam
Country [194] 0 0
Netherlands
State/province [194] 0 0
Enschede
Country [195] 0 0
Poland
State/province [195] 0 0
Dolnoslaskie
Country [196] 0 0
Poland
State/province [196] 0 0
Malopolskie
Country [197] 0 0
Poland
State/province [197] 0 0
Mazowieckie
Country [198] 0 0
Portugal
State/province [198] 0 0
Braga
Country [199] 0 0
Portugal
State/province [199] 0 0
Porto
Country [200] 0 0
Portugal
State/province [200] 0 0
Setubal
Country [201] 0 0
Portugal
State/province [201] 0 0
Viana Do Castelo
Country [202] 0 0
Puerto Rico
State/province [202] 0 0
San Juan
Country [203] 0 0
Romania
State/province [203] 0 0
Bucuresti
Country [204] 0 0
Romania
State/province [204] 0 0
Cluj
Country [205] 0 0
Romania
State/province [205] 0 0
Timi?oara
Country [206] 0 0
Russian Federation
State/province [206] 0 0
Kaliningradskaya Oblast
Country [207] 0 0
Russian Federation
State/province [207] 0 0
Novosibirskaya Oblast
Country [208] 0 0
Russian Federation
State/province [208] 0 0
Permskiy Kray
Country [209] 0 0
Russian Federation
State/province [209] 0 0
Stavropol Skiy Kray
Country [210] 0 0
Russian Federation
State/province [210] 0 0
Tatarstan, Respublika
Country [211] 0 0
Russian Federation
State/province [211] 0 0
Moscow
Country [212] 0 0
Russian Federation
State/province [212] 0 0
Murmansk
Country [213] 0 0
Russian Federation
State/province [213] 0 0
Petrozavodsk
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Pushkin
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Saint Petersburg
Country [216] 0 0
Russian Federation
State/province [216] 0 0
St. Petersburg
Country [217] 0 0
Serbia
State/province [217] 0 0
Beograd
Country [218] 0 0
Serbia
State/province [218] 0 0
Sumadijski Okrug
Country [219] 0 0
Serbia
State/province [219] 0 0
Vojvodina
Country [220] 0 0
Singapore
State/province [220] 0 0
Singapore
Country [221] 0 0
Slovakia
State/province [221] 0 0
Nitriansky Kraj
Country [222] 0 0
Slovakia
State/province [222] 0 0
Banska Bystrica
Country [223] 0 0
Slovenia
State/province [223] 0 0
Ljubljana
Country [224] 0 0
South Africa
State/province [224] 0 0
Free State
Country [225] 0 0
South Africa
State/province [225] 0 0
Gauteng
Country [226] 0 0
South Africa
State/province [226] 0 0
Western Cape
Country [227] 0 0
Spain
State/province [227] 0 0
Cantabria
Country [228] 0 0
Spain
State/province [228] 0 0
Illes Balears
Country [229] 0 0
Spain
State/province [229] 0 0
Las Palmas
Country [230] 0 0
Spain
State/province [230] 0 0
Navarra
Country [231] 0 0
Spain
State/province [231] 0 0
A Coruna
Country [232] 0 0
Spain
State/province [232] 0 0
Barcelona
Country [233] 0 0
Spain
State/province [233] 0 0
Girona
Country [234] 0 0
Spain
State/province [234] 0 0
Huelva
Country [235] 0 0
Spain
State/province [235] 0 0
Madrid
Country [236] 0 0
Spain
State/province [236] 0 0
Salamanca
Country [237] 0 0
Spain
State/province [237] 0 0
Sevilla
Country [238] 0 0
Spain
State/province [238] 0 0
Valencia
Country [239] 0 0
Sweden
State/province [239] 0 0
Hallands Lan
Country [240] 0 0
Sweden
State/province [240] 0 0
Stockholms Lan
Country [241] 0 0
Sweden
State/province [241] 0 0
Vastra Gotalands Lan
Country [242] 0 0
Switzerland
State/province [242] 0 0
Zuerich
Country [243] 0 0
Switzerland
State/province [243] 0 0
Bern
Country [244] 0 0
Taiwan
State/province [244] 0 0
Taipei
Country [245] 0 0
Taiwan
State/province [245] 0 0
Taichung
Country [246] 0 0
Taiwan
State/province [246] 0 0
Taoyuan City
Country [247] 0 0
Turkey
State/province [247] 0 0
Ankara
Country [248] 0 0
Turkey
State/province [248] 0 0
Istanbul
Country [249] 0 0
Turkey
State/province [249] 0 0
Kayseri
Country [250] 0 0
Turkey
State/province [250] 0 0
Battalgazi/malatya
Country [251] 0 0
Turkey
State/province [251] 0 0
Hatay
Country [252] 0 0
Turkey
State/province [252] 0 0
Mersin
Country [253] 0 0
Ukraine
State/province [253] 0 0
Vinnytska Oblast
Country [254] 0 0
Ukraine
State/province [254] 0 0
Kharkiv
Country [255] 0 0
Ukraine
State/province [255] 0 0
Kyiv
Country [256] 0 0
Ukraine
State/province [256] 0 0
Lviv
Country [257] 0 0
United Kingdom
State/province [257] 0 0
Cheshire West And Chester
Country [258] 0 0
United Kingdom
State/province [258] 0 0
London, City Of
Country [259] 0 0
United Kingdom
State/province [259] 0 0
Warrington
Country [260] 0 0
United Kingdom
State/province [260] 0 0
Bath
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Belfast
Country [262] 0 0
United Kingdom
State/province [262] 0 0
Birmingham
Country [263] 0 0
United Kingdom
State/province [263] 0 0
Dudley
Country [264] 0 0
United Kingdom
State/province [264] 0 0
Harrow
Country [265] 0 0
United Kingdom
State/province [265] 0 0
London
Country [266] 0 0
United Kingdom
State/province [266] 0 0
Newcastle upon Tyne
Country [267] 0 0
United Kingdom
State/province [267] 0 0
Stockport
Country [268] 0 0
United Kingdom
State/province [268] 0 0
Taunton
Country [269] 0 0
United Kingdom
State/province [269] 0 0
Tooting
Country [270] 0 0
United Kingdom
State/province [270] 0 0
Wolverhampton

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)
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/NCT03345823