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/NCT03104413




Registration number
NCT03104413
Ethics application status
Date submitted
4/04/2017
Date registered
7/04/2017

Titles & IDs
Public title
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease Who Failed Prior Biologic Treatment
Secondary ID [1] 0 0
2016-003190-17
Secondary ID [2] 0 0
M15-991
Universal Trial Number (UTN)
Trial acronym
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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - placebo for risankizumab IV
Treatment: Drugs - risankizumab SC
Treatment: Drugs - risankizumab IV

Experimental: Risankizumab Dose 1 (Induction Period 1) - Participants randomized to receive risankizumab dose 1 in Induction Period 1.

Experimental: Risankizumab Dose 2 (Induction Period 1) - Participants randomized to receive risankizumab dose 2 in Induction Period 1.

Placebo comparator: Placebo (Induction Period 1) - Participants randomized to receive placebo for risankizumab in Induction Period 1.

Experimental: Risankizumab Dose 1 (Induction Period 2) - Participants who received placebo in Period 1 and participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 1 administered by intravenous (IV) infusion in Period 2.

Experimental: Risankizumab Dose 2 (Induction Period 2) - Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection in Period 2.

Experimental: Risankizumab Dose 3 (Induction period 2) - Participants with inadequate response at Week 12 in Period 1 randomized to receive risankizumab dose 3 administered by subcutaneous (SC) injection in Period 2.


Treatment: Drugs: placebo for risankizumab IV
placebo for risankizumab administered as intravenous (IV) infusion.

Treatment: Drugs: risankizumab SC
risankizumab administered by subcutaneous (SC) injection

Treatment: Drugs: risankizumab IV
risankizumab administered as intravenous (IV) infusion.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timepoint [1] 0 0
Week 12
Primary outcome [2] 0 0
US Specific: Percentage of Participants With Endoscopic Response
Timepoint [2] 0 0
Week 12
Primary outcome [3] 0 0
Global Outside of US: Percentage of Participants With Clinical Remission
Timepoint [3] 0 0
Week 12
Primary outcome [4] 0 0
Global Outside of US: Percentage of Participants With Endoscopic Response
Timepoint [4] 0 0
Week 12
Secondary outcome [1] 0 0
US Specific: Percentage of Participants With Clinical Remission
Timepoint [1] 0 0
Week 12
Secondary outcome [2] 0 0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [2] 0 0
Week 4
Secondary outcome [3] 0 0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [3] 0 0
Week 12
Secondary outcome [4] 0 0
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Timepoint [4] 0 0
Week 12
Secondary outcome [5] 0 0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timepoint [5] 0 0
Week 4
Secondary outcome [6] 0 0
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Timepoint [6] 0 0
Week 12
Secondary outcome [7] 0 0
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Timepoint [7] 0 0
Week 12
Secondary outcome [8] 0 0
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
Timepoint [8] 0 0
Week 12
Secondary outcome [9] 0 0
US Specific: Percentage of Participants With Endoscopic Remission
Timepoint [9] 0 0
Week 12
Secondary outcome [10] 0 0
US Specific: Percentage of Participants With Enhanced Clinical Response
Timepoint [10] 0 0
Week 4
Secondary outcome [11] 0 0
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Timepoint [11] 0 0
Week 12
Secondary outcome [12] 0 0
US Specific: Percentage of Participants With Enhanced Clinical Response
Timepoint [12] 0 0
Week 12
Secondary outcome [13] 0 0
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Timepoint [13] 0 0
Week 12
Secondary outcome [14] 0 0
US Specific: Percentage of Participants With CD-Related Hospitalization
Timepoint [14] 0 0
Up to Week 12
Secondary outcome [15] 0 0
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Timepoint [15] 0 0
Week 12
Secondary outcome [16] 0 0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Timepoint [16] 0 0
Week 12
Secondary outcome [17] 0 0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [17] 0 0
Week 4
Secondary outcome [18] 0 0
Global Outside of US: Percentage of Participants With Clinical Remission
Timepoint [18] 0 0
Week 4
Secondary outcome [19] 0 0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Timepoint [19] 0 0
Week 12
Secondary outcome [20] 0 0
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Timepoint [20] 0 0
Week 12
Secondary outcome [21] 0 0
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Timepoint [21] 0 0
Week 12
Secondary outcome [22] 0 0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Timepoint [22] 0 0
Week 12
Secondary outcome [23] 0 0
Global Outside of US:: Percentage of Participants With Endoscopic Remission
Timepoint [23] 0 0
Week 12
Secondary outcome [24] 0 0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Timepoint [24] 0 0
Week 4
Secondary outcome [25] 0 0
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Timepoint [25] 0 0
Week 12
Secondary outcome [26] 0 0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Timepoint [26] 0 0
Week 12
Secondary outcome [27] 0 0
Global Outside of US: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Timepoint [27] 0 0
Week 12
Secondary outcome [28] 0 0
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Timepoint [28] 0 0
Week 12
Secondary outcome [29] 0 0
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Timepoint [29] 0 0
Week 12
Secondary outcome [30] 0 0
Global Outside of US: Change From Baseline in Work Productivity and Impairment Questionnaire - Crohn's Disease (WPAI-CD) Overall Work Impairment
Timepoint [30] 0 0
Week 12
Secondary outcome [31] 0 0
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Timepoint [31] 0 0
Week 12

Eligibility
Key inclusion criteria
* Male or female aged >=18 to <= 80 years, or minimum age of adult consent according to local regulations, at the Baseline Visit. Where locally permissible, participants 16 to < 18 years of age who meet the definition of Tanner stage 5 for development at the Baseline Visit.
* Confirmed diagnosis of CD for at least 3 months prior to Baseline.
* Crohn's disease activity index (CDAI) score 220 - 450 at Baseline.
* Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF), abdominal pain (AP) score, and Simple Endoscopic Score for Crohn's Disease (SES-CD).
* Demonstrated intolerance or inadequate response to biologic therapy for CD.
* If female, participant must meet the contraception recommendations.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
* Participants with unstable doses of concomitant Crohn's disease therapy.
* Receipt of Crohn's disease approved biologic agents (infliximab, adalimumab, certolizumab, vedolizumab, natalizumab within 8 weeks prior to Baseline or ustekinumab within 12 weeks prior to Baseline), or any investigational biologic or other agent or procedure within minimally 35 days or 5 half-lives prior to Baseline, whichever is longer.
* Prior exposure to p19 inhibitors (e.g., risankizumab).
* Complications of Crohn's disease.
* Having an ostomy or ileoanal pouch.
* Known active Coronavirus Disease 2019 (COVID-19) infection.

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 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
18/12/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
19/05/2021
Sample size
Target
Accrual to date
Final
618
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Mater Misericordiae Limited /ID# 167216 - South Brisbane
Recruitment hospital [2] 0 0
Griffith University /ID# 212631 - Southport
Recruitment hospital [3] 0 0
Lyell McEwin Hospital /ID# 211364 - Elizabeth Vale
Recruitment hospital [4] 0 0
Emeritus Research /ID# 213510 - Camberwell
Recruitment hospital [5] 0 0
Footscray Hospital /ID# 211362 - Footscray
Recruitment postcode(s) [1] 0 0
4101 - South Brisbane
Recruitment postcode(s) [2] 0 0
4222 - Southport
Recruitment postcode(s) [3] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [4] 0 0
3124 - Camberwell
Recruitment postcode(s) [5] 0 0
3011 - Footscray
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
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
Kansas
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Michigan
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
North Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Ohio
Country [21] 0 0
United States of America
State/province [21] 0 0
Oklahoma
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
South Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
United States of America
State/province [31] 0 0
West Virginia
Country [32] 0 0
Argentina
State/province [32] 0 0
Ciuadad Autonoma De Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Santa Fe
Country [34] 0 0
Argentina
State/province [34] 0 0
Cordoba
Country [35] 0 0
Austria
State/province [35] 0 0
Niederoesterreich
Country [36] 0 0
Austria
State/province [36] 0 0
Steiermark
Country [37] 0 0
Austria
State/province [37] 0 0
Wien
Country [38] 0 0
Belarus
State/province [38] 0 0
???????
Country [39] 0 0
Belgium
State/province [39] 0 0
Antwerpen
Country [40] 0 0
Belgium
State/province [40] 0 0
Bruxelles-Capitale
Country [41] 0 0
Belgium
State/province [41] 0 0
Oost-Vlaanderen
Country [42] 0 0
Belgium
State/province [42] 0 0
Bonheiden
Country [43] 0 0
Belgium
State/province [43] 0 0
Gent
Country [44] 0 0
Belgium
State/province [44] 0 0
Kortrijk
Country [45] 0 0
Belgium
State/province [45] 0 0
Merksem
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
Sarajevo
Country [48] 0 0
Bulgaria
State/province [48] 0 0
Pleven
Country [49] 0 0
Bulgaria
State/province [49] 0 0
Plovdiv
Country [50] 0 0
Bulgaria
State/province [50] 0 0
Sofia
Country [51] 0 0
Bulgaria
State/province [51] 0 0
Stara Zagora
Country [52] 0 0
Bulgaria
State/province [52] 0 0
Varna
Country [53] 0 0
Canada
State/province [53] 0 0
Alberta
Country [54] 0 0
Canada
State/province [54] 0 0
British Columbia
Country [55] 0 0
Canada
State/province [55] 0 0
Nova Scotia
Country [56] 0 0
Canada
State/province [56] 0 0
Ontario
Country [57] 0 0
Canada
State/province [57] 0 0
Quebec
Country [58] 0 0
Chile
State/province [58] 0 0
Region Metropolitana De Santiago
Country [59] 0 0
Chile
State/province [59] 0 0
Valparaíso
Country [60] 0 0
Chile
State/province [60] 0 0
Concepción
Country [61] 0 0
Chile
State/province [61] 0 0
Talcahuano
Country [62] 0 0
China
State/province [62] 0 0
Guangdong
Country [63] 0 0
China
State/province [63] 0 0
Hubei
Country [64] 0 0
China
State/province [64] 0 0
Jiangxi
Country [65] 0 0
China
State/province [65] 0 0
Shanghai
Country [66] 0 0
China
State/province [66] 0 0
Zhejiang
Country [67] 0 0
China
State/province [67] 0 0
Chengdu
Country [68] 0 0
China
State/province [68] 0 0
Pudong New District
Country [69] 0 0
China
State/province [69] 0 0
Tianjin
Country [70] 0 0
Colombia
State/province [70] 0 0
Antioquia
Country [71] 0 0
Colombia
State/province [71] 0 0
Cundinamarca
Country [72] 0 0
Croatia
State/province [72] 0 0
Grad Zagreb
Country [73] 0 0
Croatia
State/province [73] 0 0
Osjecko-baranjska Zupanija
Country [74] 0 0
Croatia
State/province [74] 0 0
Splitsko-dalmatinska Zupanija
Country [75] 0 0
Croatia
State/province [75] 0 0
Zadar
Country [76] 0 0
Czechia
State/province [76] 0 0
Praha 4
Country [77] 0 0
Czechia
State/province [77] 0 0
Hradec Kralove
Country [78] 0 0
Czechia
State/province [78] 0 0
Olomouc
Country [79] 0 0
Czechia
State/province [79] 0 0
Pardubice
Country [80] 0 0
Czechia
State/province [80] 0 0
Praha
Country [81] 0 0
Denmark
State/province [81] 0 0
Hovedstaden
Country [82] 0 0
Denmark
State/province [82] 0 0
Midtjylland
Country [83] 0 0
Denmark
State/province [83] 0 0
Sjælland
Country [84] 0 0
Denmark
State/province [84] 0 0
Syddanmark
Country [85] 0 0
Denmark
State/province [85] 0 0
Aalborg
Country [86] 0 0
Denmark
State/province [86] 0 0
Odense C
Country [87] 0 0
Egypt
State/province [87] 0 0
Al Sharqia
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
Estonia
State/province [90] 0 0
Harjumaa
Country [91] 0 0
Estonia
State/province [91] 0 0
Tallinn
Country [92] 0 0
France
State/province [92] 0 0
Alpes-Maritimes
Country [93] 0 0
France
State/province [93] 0 0
Auvergne-Rhone-Alpes
Country [94] 0 0
France
State/province [94] 0 0
Gironde
Country [95] 0 0
France
State/province [95] 0 0
Hauts-de-France
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
Loire
Country [99] 0 0
France
State/province [99] 0 0
Meurthe-et-Moselle
Country [100] 0 0
France
State/province [100] 0 0
Somme
Country [101] 0 0
France
State/province [101] 0 0
La Tronche
Country [102] 0 0
France
State/province [102] 0 0
Rennes
Country [103] 0 0
Germany
State/province [103] 0 0
Baden-Wuerttemberg
Country [104] 0 0
Germany
State/province [104] 0 0
Bayern
Country [105] 0 0
Germany
State/province [105] 0 0
Hessen
Country [106] 0 0
Germany
State/province [106] 0 0
Nordrhein-Westfalen
Country [107] 0 0
Germany
State/province [107] 0 0
Saarland
Country [108] 0 0
Germany
State/province [108] 0 0
Schleswig-Holstein
Country [109] 0 0
Germany
State/province [109] 0 0
Berlin-Zehlendorf
Country [110] 0 0
Germany
State/province [110] 0 0
Berlin
Country [111] 0 0
Germany
State/province [111] 0 0
Braunschweig
Country [112] 0 0
Germany
State/province [112] 0 0
Dachau
Country [113] 0 0
Germany
State/province [113] 0 0
Frankfurt am Main
Country [114] 0 0
Germany
State/province [114] 0 0
Freiburg
Country [115] 0 0
Germany
State/province [115] 0 0
Hamburg
Country [116] 0 0
Germany
State/province [116] 0 0
Hannover
Country [117] 0 0
Germany
State/province [117] 0 0
Leipzig
Country [118] 0 0
Germany
State/province [118] 0 0
Lueneburg
Country [119] 0 0
Germany
State/province [119] 0 0
Magdeburg
Country [120] 0 0
Germany
State/province [120] 0 0
Minden
Country [121] 0 0
Germany
State/province [121] 0 0
Regensburg
Country [122] 0 0
Germany
State/province [122] 0 0
Wiesbaden
Country [123] 0 0
Greece
State/province [123] 0 0
Attiki
Country [124] 0 0
Greece
State/province [124] 0 0
Kriti
Country [125] 0 0
Greece
State/province [125] 0 0
Athens
Country [126] 0 0
Greece
State/province [126] 0 0
Ioannina
Country [127] 0 0
Greece
State/province [127] 0 0
Pireaus
Country [128] 0 0
Greece
State/province [128] 0 0
Thessaloniki
Country [129] 0 0
Ireland
State/province [129] 0 0
Dublin
Country [130] 0 0
Ireland
State/province [130] 0 0
Galway
Country [131] 0 0
Israel
State/province [131] 0 0
HaDarom
Country [132] 0 0
Israel
State/province [132] 0 0
Tel-Aviv
Country [133] 0 0
Israel
State/province [133] 0 0
Haifa
Country [134] 0 0
Israel
State/province [134] 0 0
Jerusalem
Country [135] 0 0
Italy
State/province [135] 0 0
Ancona
Country [136] 0 0
Italy
State/province [136] 0 0
Calabria
Country [137] 0 0
Italy
State/province [137] 0 0
Emilia-Romagna
Country [138] 0 0
Italy
State/province [138] 0 0
Lazio
Country [139] 0 0
Italy
State/province [139] 0 0
Liguria
Country [140] 0 0
Italy
State/province [140] 0 0
Milano
Country [141] 0 0
Italy
State/province [141] 0 0
Roma
Country [142] 0 0
Italy
State/province [142] 0 0
Toscana
Country [143] 0 0
Italy
State/province [143] 0 0
Verona
Country [144] 0 0
Italy
State/province [144] 0 0
Bologna
Country [145] 0 0
Italy
State/province [145] 0 0
Catania
Country [146] 0 0
Italy
State/province [146] 0 0
Milan
Country [147] 0 0
Italy
State/province [147] 0 0
Pavia
Country [148] 0 0
Korea, Republic of
State/province [148] 0 0
Gyeonggido
Country [149] 0 0
Korea, Republic of
State/province [149] 0 0
Seoul Teugbyeolsi
Country [150] 0 0
Korea, Republic of
State/province [150] 0 0
Busan
Country [151] 0 0
Korea, Republic of
State/province [151] 0 0
Daegu
Country [152] 0 0
Korea, Republic of
State/province [152] 0 0
Daejeon
Country [153] 0 0
Korea, Republic of
State/province [153] 0 0
Seoul
Country [154] 0 0
Latvia
State/province [154] 0 0
Riga
Country [155] 0 0
Lithuania
State/province [155] 0 0
Kaunas
Country [156] 0 0
Lithuania
State/province [156] 0 0
Vilnius
Country [157] 0 0
Malaysia
State/province [157] 0 0
Sabah
Country [158] 0 0
Malaysia
State/province [158] 0 0
Selangor
Country [159] 0 0
Malaysia
State/province [159] 0 0
Kelantan
Country [160] 0 0
Mexico
State/province [160] 0 0
Jalisco
Country [161] 0 0
Mexico
State/province [161] 0 0
Morelos
Country [162] 0 0
Mexico
State/province [162] 0 0
Yucatan
Country [163] 0 0
Mexico
State/province [163] 0 0
Del. Benito Juárez
Country [164] 0 0
Netherlands
State/province [164] 0 0
Amsterdam
Country [165] 0 0
Netherlands
State/province [165] 0 0
Tilburg
Country [166] 0 0
New Zealand
State/province [166] 0 0
Canterbury
Country [167] 0 0
New Zealand
State/province [167] 0 0
Otago
Country [168] 0 0
New Zealand
State/province [168] 0 0
Auckland
Country [169] 0 0
New Zealand
State/province [169] 0 0
Wellington
Country [170] 0 0
Poland
State/province [170] 0 0
Dolnoslaskie
Country [171] 0 0
Poland
State/province [171] 0 0
Lodzkie
Country [172] 0 0
Poland
State/province [172] 0 0
Lubelskie
Country [173] 0 0
Poland
State/province [173] 0 0
Mazowieckie
Country [174] 0 0
Poland
State/province [174] 0 0
Podkarpackie
Country [175] 0 0
Poland
State/province [175] 0 0
Pomorskie
Country [176] 0 0
Poland
State/province [176] 0 0
Slaskie
Country [177] 0 0
Poland
State/province [177] 0 0
Warminsko-mazurskie
Country [178] 0 0
Poland
State/province [178] 0 0
Warsaw
Country [179] 0 0
Poland
State/province [179] 0 0
Wroclaw
Country [180] 0 0
Portugal
State/province [180] 0 0
Braga
Country [181] 0 0
Portugal
State/province [181] 0 0
Faro
Country [182] 0 0
Portugal
State/province [182] 0 0
Porto
Country [183] 0 0
Portugal
State/province [183] 0 0
Almada
Country [184] 0 0
Portugal
State/province [184] 0 0
Lisboa
Country [185] 0 0
Portugal
State/province [185] 0 0
Loures
Country [186] 0 0
Portugal
State/province [186] 0 0
Viseu
Country [187] 0 0
Romania
State/province [187] 0 0
Bucuresti
Country [188] 0 0
Romania
State/province [188] 0 0
Bucharest
Country [189] 0 0
Romania
State/province [189] 0 0
Cluj
Country [190] 0 0
Romania
State/province [190] 0 0
Timisoara
Country [191] 0 0
Romania
State/province [191] 0 0
Timi?oara
Country [192] 0 0
Russian Federation
State/province [192] 0 0
Kemerovskaya Oblast
Country [193] 0 0
Russian Federation
State/province [193] 0 0
Permskiy Kray
Country [194] 0 0
Russian Federation
State/province [194] 0 0
Stavropol Skiy Kray
Country [195] 0 0
Russian Federation
State/province [195] 0 0
Tverskaya Oblast
Country [196] 0 0
Russian Federation
State/province [196] 0 0
Tyumenskaya Oblast
Country [197] 0 0
Russian Federation
State/province [197] 0 0
Udmurtskaya Respublika
Country [198] 0 0
Russian Federation
State/province [198] 0 0
Moscow
Country [199] 0 0
Russian Federation
State/province [199] 0 0
St. Petersburg
Country [200] 0 0
Russian Federation
State/province [200] 0 0
Ulyanovsk
Country [201] 0 0
Serbia
State/province [201] 0 0
Beograd
Country [202] 0 0
Serbia
State/province [202] 0 0
Sumadijski Okrug
Country [203] 0 0
Serbia
State/province [203] 0 0
Vojvodina
Country [204] 0 0
Serbia
State/province [204] 0 0
Belgrade
Country [205] 0 0
Singapore
State/province [205] 0 0
Singapore
Country [206] 0 0
Slovakia
State/province [206] 0 0
Banska Bystrica
Country [207] 0 0
Slovakia
State/province [207] 0 0
Martin
Country [208] 0 0
Slovakia
State/province [208] 0 0
Nitra
Country [209] 0 0
Slovakia
State/province [209] 0 0
Presov
Country [210] 0 0
South Africa
State/province [210] 0 0
Gauteng
Country [211] 0 0
South Africa
State/province [211] 0 0
Western Cape
Country [212] 0 0
Spain
State/province [212] 0 0
A Coruna
Country [213] 0 0
Spain
State/province [213] 0 0
Barcelona
Country [214] 0 0
Spain
State/province [214] 0 0
Vizcaya
Country [215] 0 0
Spain
State/province [215] 0 0
Madrid
Country [216] 0 0
Spain
State/province [216] 0 0
Salamanca
Country [217] 0 0
Spain
State/province [217] 0 0
Sevilla
Country [218] 0 0
Spain
State/province [218] 0 0
Valencia
Country [219] 0 0
Spain
State/province [219] 0 0
Zaragoza
Country [220] 0 0
Switzerland
State/province [220] 0 0
Basel-Stadt
Country [221] 0 0
Switzerland
State/province [221] 0 0
Zuerich
Country [222] 0 0
Taiwan
State/province [222] 0 0
Taichung City
Country [223] 0 0
Taiwan
State/province [223] 0 0
Taichung
Country [224] 0 0
Taiwan
State/province [224] 0 0
Tainan City
Country [225] 0 0
Taiwan
State/province [225] 0 0
Taipei City
Country [226] 0 0
Ukraine
State/province [226] 0 0
Uzhhorod
Country [227] 0 0
Ukraine
State/province [227] 0 0
????
Country [228] 0 0
United Kingdom
State/province [228] 0 0
Scotland
Country [229] 0 0
United Kingdom
State/province [229] 0 0
Surrey
Country [230] 0 0
United Kingdom
State/province [230] 0 0
Barnsley
Country [231] 0 0
United Kingdom
State/province [231] 0 0
Birmingham
Country [232] 0 0
United Kingdom
State/province [232] 0 0
Cambridge
Country [233] 0 0
United Kingdom
State/province [233] 0 0
Edinburgh
Country [234] 0 0
United Kingdom
State/province [234] 0 0
Hull
Country [235] 0 0
United Kingdom
State/province [235] 0 0
London
Country [236] 0 0
United Kingdom
State/province [236] 0 0
Newcastle Upon Tyne
Country [237] 0 0
United Kingdom
State/province [237] 0 0
Oxford
Country [238] 0 0
United Kingdom
State/province [238] 0 0
Salford

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/NCT03104413