Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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/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
Query!
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
Query!
Secondary ID [1]
0
0
2016-003190-17
Query!
Secondary ID [2]
0
0
M15-991
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Inflammatory bowel disease
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Crohn's disease
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Query!
Assessment method [1]
0
0
The CDAI consists of 8 components; 7 are based on participant diary entries, participant interviews, physical examinations, measurement of body weight and height and 1 is based on laboratory analysis. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Query!
Timepoint [1]
0
0
Week 12
Query!
Primary outcome [2]
0
0
US Specific: Percentage of Participants With Endoscopic Response
Query!
Assessment method [2]
0
0
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Query!
Timepoint [2]
0
0
Week 12
Query!
Primary outcome [3]
0
0
Global Outside of US: Percentage of Participants With Clinical Remission
Query!
Assessment method [3]
0
0
Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.
Query!
Timepoint [3]
0
0
Week 12
Query!
Primary outcome [4]
0
0
Global Outside of US: Percentage of Participants With Endoscopic Response
Query!
Assessment method [4]
0
0
The SES-CD assesses endoscopic disease severity by evidence of active intestinal mucosal inflammation. Endoscopic response is defined as a decrease in SES-CD \> 50% from Baseline (or for participants with isolated ileal disease and a Baseline SES-CD of 4, at least a 2-point reduction from Baseline).
Query!
Timepoint [4]
0
0
Week 12
Query!
Secondary outcome [1]
0
0
US Specific: Percentage of Participants With Clinical Remission
Query!
Assessment method [1]
0
0
Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.
Query!
Timepoint [1]
0
0
Week 12
Query!
Secondary outcome [2]
0
0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Query!
Assessment method [2]
0
0
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
Query!
Timepoint [2]
0
0
Week 4
Query!
Secondary outcome [3]
0
0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Query!
Assessment method [3]
0
0
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
Query!
Timepoint [3]
0
0
Week 12
Query!
Secondary outcome [4]
0
0
US Specific: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Query!
Assessment method [4]
0
0
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Query!
Timepoint [4]
0
0
Week 12
Query!
Secondary outcome [5]
0
0
US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Query!
Assessment method [5]
0
0
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Query!
Timepoint [5]
0
0
Week 4
Query!
Secondary outcome [6]
0
0
US Specific: Percentage of Participants With CDAI Clinical Response and Endoscopic Response
Query!
Assessment method [6]
0
0
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
Endoscopic response was a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Query!
Timepoint [6]
0
0
Week 12
Query!
Secondary outcome [7]
0
0
US Specific: Percentage of Participants With Stool Frequency (SF) Remission
Query!
Assessment method [7]
0
0
Stool Frequency (SF) remission is defined as an average daily SF \<= 2.8 and not worse than baseline.
Query!
Timepoint [7]
0
0
Week 12
Query!
Secondary outcome [8]
0
0
US Specific: Percentage of Participants With Abdominal Pain (AP) Remission
Query!
Assessment method [8]
0
0
The Abdominal Pain rating is an assessment that is graded from 0 to 3: 0= None, 1= Mild, 2= Moderate and 3= Severe. AP remission is defined as average daily AP score \<= 1 and not worse than baseline.
Query!
Timepoint [8]
0
0
Week 12
Query!
Secondary outcome [9]
0
0
US Specific: Percentage of Participants With Endoscopic Remission
Query!
Assessment method [9]
0
0
Endoscopic remission: SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Query!
Timepoint [9]
0
0
Week 12
Query!
Secondary outcome [10]
0
0
US Specific: Percentage of Participants With Enhanced Clinical Response
Query!
Assessment method [10]
0
0
Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Query!
Timepoint [10]
0
0
Week 4
Query!
Secondary outcome [11]
0
0
US Specific: Percentage of Participants With Ulcer-Free Endoscopy
Query!
Assessment method [11]
0
0
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore = 1 at Baseline
Query!
Timepoint [11]
0
0
Week 12
Query!
Secondary outcome [12]
0
0
US Specific: Percentage of Participants With Enhanced Clinical Response
Query!
Assessment method [12]
0
0
Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Query!
Timepoint [12]
0
0
Week 12
Query!
Secondary outcome [13]
0
0
US Specific: Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs), in Participants With EIMs at Baseline Baseline
Query!
Assessment method [13]
0
0
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Query!
Timepoint [13]
0
0
Week 12
Query!
Secondary outcome [14]
0
0
US Specific: Percentage of Participants With CD-Related Hospitalization
Query!
Assessment method [14]
0
0
Participants with at least one admission to the hospital due to Crohn's Disease.
Query!
Timepoint [14]
0
0
Up to Week 12
Query!
Secondary outcome [15]
0
0
US Specific: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Query!
Assessment method [15]
0
0
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Query!
Timepoint [15]
0
0
Week 12
Query!
Secondary outcome [16]
0
0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission
Query!
Assessment method [16]
0
0
The CDAI consists of 8 components; 6 are based on participant diary entries, participant interviews, and physical examinations, and 2 are based on laboratory analysis, and measurement of body weight and height. CDAI clinical remission of Crohn's disease is defined as CDAI \< 150.
Query!
Timepoint [16]
0
0
Week 12
Query!
Secondary outcome [17]
0
0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Query!
Assessment method [17]
0
0
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
Query!
Timepoint [17]
0
0
Week 4
Query!
Secondary outcome [18]
0
0
Global Outside of US: Percentage of Participants With Clinical Remission
Query!
Assessment method [18]
0
0
Clinical remission is defined as using the average daily Stool Frequency (SF) = 2.8 and not worse than Baseline AND average daily Abdominal Pain (AP) score = 1 and not worse than Baseline.
Query!
Timepoint [18]
0
0
Week 4
Query!
Secondary outcome [19]
0
0
Global Outside of US: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Response
Query!
Assessment method [19]
0
0
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Higher CDAI scores indicate more severe disease. CDAI clinical response is defined as reduction of CDAI = 100 points from baseline.
Query!
Timepoint [19]
0
0
Week 12
Query!
Secondary outcome [20]
0
0
Global Outside of US: Change From Baseline of Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
Query!
Assessment method [20]
0
0
The FACIT-Fatigue scale is a 13-item tool that measures an individual's level of fatigue during their usual daily activities over the past 7 days. Each of the fatigue and impact of fatigue items are measured on a four point Likert scale. The FACIT Fatigue Scale is the sum of the individual 13 scores and ranges from 0 to 52 where higher scores indicate better the quality of life. A positive change from baseline indicates improvement.
Query!
Timepoint [20]
0
0
Week 12
Query!
Secondary outcome [21]
0
0
Global Outside of US: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Query!
Assessment method [21]
0
0
The IBDQ is a 32-item (ranges 1 - 7) self-report questionnaire for patients with IBD to evaluate the patient reported outcomes across 4 dimensions: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). The IBDQ total Score ranges from 32 to 224 with a higher score indicating better outcome.
Query!
Timepoint [21]
0
0
Week 12
Query!
Secondary outcome [22]
0
0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response and Endoscopic Response
Query!
Assessment method [22]
0
0
Enhanced clinical response was defined as = 60% decrease in average daily Stool Frequency and/or = 35% decrease in average daily Abdominal Pain score and both not worse than baseline, and/or clinical remission. Endoscopic Response was defined as a decrease in Simplified Endoscopic Score for Crohn's Disease (SES-CD) \> 50% from Baseline (or for subjects with isolated ileal disease and a Baseline SES-CD of 4, at least a 2 point reduction from Baseline).
Query!
Timepoint [22]
0
0
Week 12
Query!
Secondary outcome [23]
0
0
Global Outside of US:: Percentage of Participants With Endoscopic Remission
Query!
Assessment method [23]
0
0
Endoscopic remission: SES-CD = 4 and at least a 2 point reduction versus baseline and no subscore greater than 1 in any individual variable
Query!
Timepoint [23]
0
0
Week 12
Query!
Secondary outcome [24]
0
0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Query!
Assessment method [24]
0
0
Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Query!
Timepoint [24]
0
0
Week 4
Query!
Secondary outcome [25]
0
0
Global Outside of US: Percentage of Participants With Ulcer-Free Endoscopy
Query!
Assessment method [25]
0
0
Ulcer-free endoscopy: SES-CD ulcerated surface subscore of 0 in subjects with SES-CD ulcerated surface subscore = 1 at Baseline
Query!
Timepoint [25]
0
0
Week 12
Query!
Secondary outcome [26]
0
0
Global Outside of US: Percentage of Participants With Enhanced Clinical Response
Query!
Assessment method [26]
0
0
Enhanced clinical response: = 60% decrease in average daily SF and/or = 35% decrease in average daily AP score and both not worse than Baseline, and/or clinical remission
Query!
Timepoint [26]
0
0
Week 12
Query!
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
Query!
Assessment method [27]
0
0
Manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Query!
Timepoint [27]
0
0
Week 12
Query!
Secondary outcome [28]
0
0
Global Outside of US: Percentage of Participants With CD-Related Hospitalization
Query!
Assessment method [28]
0
0
Participants with at least one admission to the hospital due to Crohn's Disease.
Query!
Timepoint [28]
0
0
Week 12
Query!
Secondary outcome [29]
0
0
Global Outside of US: Percentage of Participants Without Draining Fistulas in Participants With Draining Fistulas at Baseline
Query!
Assessment method [29]
0
0
Participants without draining fistulas at Week 12 in participants who had draining fistulas at baseline.
Query!
Timepoint [29]
0
0
Week 12
Query!
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
Query!
Assessment method [30]
0
0
WPAI: CD is a questionnaire used to evaluate lost productivity due to CD ; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. Total work productivity impairment takes into account both hours missed due to CD symptoms and the patient's assessment of the degree to which CD affected their productivity while working (overall work impairment \[OWI\]). WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity.
Query!
Timepoint [30]
0
0
Week 12
Query!
Secondary outcome [31]
0
0
Global Outside of US: Change From Baseline in Short Form-36 (SF-36) Physical Component Summary (PCS) Score
Query!
Assessment method [31]
0
0
The Short Form-36 Health Survey determined participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 comprise the physical component of the SF-36. Scores on each item were summed and averaged (range = 0-100); a positive change from Baseline indicates improvement.
Query!
Timepoint [31]
0
0
Week 12
Query!
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.
Query!
Minimum age
16
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/12/2017
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
19/05/2021
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
618
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Query!
Recruitment hospital [1]
0
0
Mater Misericordiae Limited /ID# 167216 - South Brisbane
Query!
Recruitment hospital [2]
0
0
Griffith University /ID# 212631 - Southport
Query!
Recruitment hospital [3]
0
0
Lyell McEwin Hospital /ID# 211364 - Elizabeth Vale
Query!
Recruitment hospital [4]
0
0
Emeritus Research /ID# 213510 - Camberwell
Query!
Recruitment hospital [5]
0
0
Footscray Hospital /ID# 211362 - Footscray
Query!
Recruitment postcode(s) [1]
0
0
4101 - South Brisbane
Query!
Recruitment postcode(s) [2]
0
0
4222 - Southport
Query!
Recruitment postcode(s) [3]
0
0
5112 - Elizabeth Vale
Query!
Recruitment postcode(s) [4]
0
0
3124 - Camberwell
Query!
Recruitment postcode(s) [5]
0
0
3011 - Footscray
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arkansas
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Colorado
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Connecticut
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Florida
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Georgia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Illinois
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Kansas
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Kentucky
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Louisiana
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Maryland
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Michigan
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Minnesota
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Nebraska
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Nevada
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
New York
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
North Carolina
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
North Dakota
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Ohio
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Oklahoma
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Oregon
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Pennsylvania
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
South Carolina
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
South Dakota
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Tennessee
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
Texas
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Utah
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Virginia
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Washington
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
West Virginia
Query!
Country [32]
0
0
Argentina
Query!
State/province [32]
0
0
Ciuadad Autonoma De Buenos Aires
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Santa Fe
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
Cordoba
Query!
Country [35]
0
0
Austria
Query!
State/province [35]
0
0
Niederoesterreich
Query!
Country [36]
0
0
Austria
Query!
State/province [36]
0
0
Steiermark
Query!
Country [37]
0
0
Austria
Query!
State/province [37]
0
0
Wien
Query!
Country [38]
0
0
Belarus
Query!
State/province [38]
0
0
???????
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Antwerpen
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Bruxelles-Capitale
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Oost-Vlaanderen
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Bonheiden
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Gent
Query!
Country [44]
0
0
Belgium
Query!
State/province [44]
0
0
Kortrijk
Query!
Country [45]
0
0
Belgium
Query!
State/province [45]
0
0
Merksem
Query!
Country [46]
0
0
Bosnia and Herzegovina
Query!
State/province [46]
0
0
Republika Srpska
Query!
Country [47]
0
0
Bosnia and Herzegovina
Query!
State/province [47]
0
0
Sarajevo
Query!
Country [48]
0
0
Bulgaria
Query!
State/province [48]
0
0
Pleven
Query!
Country [49]
0
0
Bulgaria
Query!
State/province [49]
0
0
Plovdiv
Query!
Country [50]
0
0
Bulgaria
Query!
State/province [50]
0
0
Sofia
Query!
Country [51]
0
0
Bulgaria
Query!
State/province [51]
0
0
Stara Zagora
Query!
Country [52]
0
0
Bulgaria
Query!
State/province [52]
0
0
Varna
Query!
Country [53]
0
0
Canada
Query!
State/province [53]
0
0
Alberta
Query!
Country [54]
0
0
Canada
Query!
State/province [54]
0
0
British Columbia
Query!
Country [55]
0
0
Canada
Query!
State/province [55]
0
0
Nova Scotia
Query!
Country [56]
0
0
Canada
Query!
State/province [56]
0
0
Ontario
Query!
Country [57]
0
0
Canada
Query!
State/province [57]
0
0
Quebec
Query!
Country [58]
0
0
Chile
Query!
State/province [58]
0
0
Region Metropolitana De Santiago
Query!
Country [59]
0
0
Chile
Query!
State/province [59]
0
0
Valparaíso
Query!
Country [60]
0
0
Chile
Query!
State/province [60]
0
0
Concepción
Query!
Country [61]
0
0
Chile
Query!
State/province [61]
0
0
Talcahuano
Query!
Country [62]
0
0
China
Query!
State/province [62]
0
0
Guangdong
Query!
Country [63]
0
0
China
Query!
State/province [63]
0
0
Hubei
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Jiangxi
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Shanghai
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Zhejiang
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Chengdu
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Pudong New District
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Tianjin
Query!
Country [70]
0
0
Colombia
Query!
State/province [70]
0
0
Antioquia
Query!
Country [71]
0
0
Colombia
Query!
State/province [71]
0
0
Cundinamarca
Query!
Country [72]
0
0
Croatia
Query!
State/province [72]
0
0
Grad Zagreb
Query!
Country [73]
0
0
Croatia
Query!
State/province [73]
0
0
Osjecko-baranjska Zupanija
Query!
Country [74]
0
0
Croatia
Query!
State/province [74]
0
0
Splitsko-dalmatinska Zupanija
Query!
Country [75]
0
0
Croatia
Query!
State/province [75]
0
0
Zadar
Query!
Country [76]
0
0
Czechia
Query!
State/province [76]
0
0
Praha 4
Query!
Country [77]
0
0
Czechia
Query!
State/province [77]
0
0
Hradec Kralove
Query!
Country [78]
0
0
Czechia
Query!
State/province [78]
0
0
Olomouc
Query!
Country [79]
0
0
Czechia
Query!
State/province [79]
0
0
Pardubice
Query!
Country [80]
0
0
Czechia
Query!
State/province [80]
0
0
Praha
Query!
Country [81]
0
0
Denmark
Query!
State/province [81]
0
0
Hovedstaden
Query!
Country [82]
0
0
Denmark
Query!
State/province [82]
0
0
Midtjylland
Query!
Country [83]
0
0
Denmark
Query!
State/province [83]
0
0
Sjælland
Query!
Country [84]
0
0
Denmark
Query!
State/province [84]
0
0
Syddanmark
Query!
Country [85]
0
0
Denmark
Query!
State/province [85]
0
0
Aalborg
Query!
Country [86]
0
0
Denmark
Query!
State/province [86]
0
0
Odense C
Query!
Country [87]
0
0
Egypt
Query!
State/province [87]
0
0
Al Sharqia
Query!
Country [88]
0
0
Egypt
Query!
State/province [88]
0
0
Alexandria
Query!
Country [89]
0
0
Egypt
Query!
State/province [89]
0
0
Cairo
Query!
Country [90]
0
0
Estonia
Query!
State/province [90]
0
0
Harjumaa
Query!
Country [91]
0
0
Estonia
Query!
State/province [91]
0
0
Tallinn
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Alpes-Maritimes
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Auvergne-Rhone-Alpes
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Gironde
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Hauts-de-France
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Herault
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Ile-de-France
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Loire
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Meurthe-et-Moselle
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Somme
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
La Tronche
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Rennes
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Baden-Wuerttemberg
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Bayern
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Hessen
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Nordrhein-Westfalen
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Saarland
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Schleswig-Holstein
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Berlin-Zehlendorf
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Berlin
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Braunschweig
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Dachau
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Frankfurt am Main
Query!
Country [114]
0
0
Germany
Query!
State/province [114]
0
0
Freiburg
Query!
Country [115]
0
0
Germany
Query!
State/province [115]
0
0
Hamburg
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Hannover
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Leipzig
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Lueneburg
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Magdeburg
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Minden
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Regensburg
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Wiesbaden
Query!
Country [123]
0
0
Greece
Query!
State/province [123]
0
0
Attiki
Query!
Country [124]
0
0
Greece
Query!
State/province [124]
0
0
Kriti
Query!
Country [125]
0
0
Greece
Query!
State/province [125]
0
0
Athens
Query!
Country [126]
0
0
Greece
Query!
State/province [126]
0
0
Ioannina
Query!
Country [127]
0
0
Greece
Query!
State/province [127]
0
0
Pireaus
Query!
Country [128]
0
0
Greece
Query!
State/province [128]
0
0
Thessaloniki
Query!
Country [129]
0
0
Ireland
Query!
State/province [129]
0
0
Dublin
Query!
Country [130]
0
0
Ireland
Query!
State/province [130]
0
0
Galway
Query!
Country [131]
0
0
Israel
Query!
State/province [131]
0
0
HaDarom
Query!
Country [132]
0
0
Israel
Query!
State/province [132]
0
0
Tel-Aviv
Query!
Country [133]
0
0
Israel
Query!
State/province [133]
0
0
Haifa
Query!
Country [134]
0
0
Israel
Query!
State/province [134]
0
0
Jerusalem
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Ancona
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Calabria
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Emilia-Romagna
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Lazio
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Liguria
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Milano
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Roma
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Toscana
Query!
Country [143]
0
0
Italy
Query!
State/province [143]
0
0
Verona
Query!
Country [144]
0
0
Italy
Query!
State/province [144]
0
0
Bologna
Query!
Country [145]
0
0
Italy
Query!
State/province [145]
0
0
Catania
Query!
Country [146]
0
0
Italy
Query!
State/province [146]
0
0
Milan
Query!
Country [147]
0
0
Italy
Query!
State/province [147]
0
0
Pavia
Query!
Country [148]
0
0
Korea, Republic of
Query!
State/province [148]
0
0
Gyeonggido
Query!
Country [149]
0
0
Korea, Republic of
Query!
State/province [149]
0
0
Seoul Teugbyeolsi
Query!
Country [150]
0
0
Korea, Republic of
Query!
State/province [150]
0
0
Busan
Query!
Country [151]
0
0
Korea, Republic of
Query!
State/province [151]
0
0
Daegu
Query!
Country [152]
0
0
Korea, Republic of
Query!
State/province [152]
0
0
Daejeon
Query!
Country [153]
0
0
Korea, Republic of
Query!
State/province [153]
0
0
Seoul
Query!
Country [154]
0
0
Latvia
Query!
State/province [154]
0
0
Riga
Query!
Country [155]
0
0
Lithuania
Query!
State/province [155]
0
0
Kaunas
Query!
Country [156]
0
0
Lithuania
Query!
State/province [156]
0
0
Vilnius
Query!
Country [157]
0
0
Malaysia
Query!
State/province [157]
0
0
Sabah
Query!
Country [158]
0
0
Malaysia
Query!
State/province [158]
0
0
Selangor
Query!
Country [159]
0
0
Malaysia
Query!
State/province [159]
0
0
Kelantan
Query!
Country [160]
0
0
Mexico
Query!
State/province [160]
0
0
Jalisco
Query!
Country [161]
0
0
Mexico
Query!
State/province [161]
0
0
Morelos
Query!
Country [162]
0
0
Mexico
Query!
State/province [162]
0
0
Yucatan
Query!
Country [163]
0
0
Mexico
Query!
State/province [163]
0
0
Del. Benito Juárez
Query!
Country [164]
0
0
Netherlands
Query!
State/province [164]
0
0
Amsterdam
Query!
Country [165]
0
0
Netherlands
Query!
State/province [165]
0
0
Tilburg
Query!
Country [166]
0
0
New Zealand
Query!
State/province [166]
0
0
Canterbury
Query!
Country [167]
0
0
New Zealand
Query!
State/province [167]
0
0
Otago
Query!
Country [168]
0
0
New Zealand
Query!
State/province [168]
0
0
Auckland
Query!
Country [169]
0
0
New Zealand
Query!
State/province [169]
0
0
Wellington
Query!
Country [170]
0
0
Poland
Query!
State/province [170]
0
0
Dolnoslaskie
Query!
Country [171]
0
0
Poland
Query!
State/province [171]
0
0
Lodzkie
Query!
Country [172]
0
0
Poland
Query!
State/province [172]
0
0
Lubelskie
Query!
Country [173]
0
0
Poland
Query!
State/province [173]
0
0
Mazowieckie
Query!
Country [174]
0
0
Poland
Query!
State/province [174]
0
0
Podkarpackie
Query!
Country [175]
0
0
Poland
Query!
State/province [175]
0
0
Pomorskie
Query!
Country [176]
0
0
Poland
Query!
State/province [176]
0
0
Slaskie
Query!
Country [177]
0
0
Poland
Query!
State/province [177]
0
0
Warminsko-mazurskie
Query!
Country [178]
0
0
Poland
Query!
State/province [178]
0
0
Warsaw
Query!
Country [179]
0
0
Poland
Query!
State/province [179]
0
0
Wroclaw
Query!
Country [180]
0
0
Portugal
Query!
State/province [180]
0
0
Braga
Query!
Country [181]
0
0
Portugal
Query!
State/province [181]
0
0
Faro
Query!
Country [182]
0
0
Portugal
Query!
State/province [182]
0
0
Porto
Query!
Country [183]
0
0
Portugal
Query!
State/province [183]
0
0
Almada
Query!
Country [184]
0
0
Portugal
Query!
State/province [184]
0
0
Lisboa
Query!
Country [185]
0
0
Portugal
Query!
State/province [185]
0
0
Loures
Query!
Country [186]
0
0
Portugal
Query!
State/province [186]
0
0
Viseu
Query!
Country [187]
0
0
Romania
Query!
State/province [187]
0
0
Bucuresti
Query!
Country [188]
0
0
Romania
Query!
State/province [188]
0
0
Bucharest
Query!
Country [189]
0
0
Romania
Query!
State/province [189]
0
0
Cluj
Query!
Country [190]
0
0
Romania
Query!
State/province [190]
0
0
Timisoara
Query!
Country [191]
0
0
Romania
Query!
State/province [191]
0
0
Timi?oara
Query!
Country [192]
0
0
Russian Federation
Query!
State/province [192]
0
0
Kemerovskaya Oblast
Query!
Country [193]
0
0
Russian Federation
Query!
State/province [193]
0
0
Permskiy Kray
Query!
Country [194]
0
0
Russian Federation
Query!
State/province [194]
0
0
Stavropol Skiy Kray
Query!
Country [195]
0
0
Russian Federation
Query!
State/province [195]
0
0
Tverskaya Oblast
Query!
Country [196]
0
0
Russian Federation
Query!
State/province [196]
0
0
Tyumenskaya Oblast
Query!
Country [197]
0
0
Russian Federation
Query!
State/province [197]
0
0
Udmurtskaya Respublika
Query!
Country [198]
0
0
Russian Federation
Query!
State/province [198]
0
0
Moscow
Query!
Country [199]
0
0
Russian Federation
Query!
State/province [199]
0
0
St. Petersburg
Query!
Country [200]
0
0
Russian Federation
Query!
State/province [200]
0
0
Ulyanovsk
Query!
Country [201]
0
0
Serbia
Query!
State/province [201]
0
0
Beograd
Query!
Country [202]
0
0
Serbia
Query!
State/province [202]
0
0
Sumadijski Okrug
Query!
Country [203]
0
0
Serbia
Query!
State/province [203]
0
0
Vojvodina
Query!
Country [204]
0
0
Serbia
Query!
State/province [204]
0
0
Belgrade
Query!
Country [205]
0
0
Singapore
Query!
State/province [205]
0
0
Singapore
Query!
Country [206]
0
0
Slovakia
Query!
State/province [206]
0
0
Banska Bystrica
Query!
Country [207]
0
0
Slovakia
Query!
State/province [207]
0
0
Martin
Query!
Country [208]
0
0
Slovakia
Query!
State/province [208]
0
0
Nitra
Query!
Country [209]
0
0
Slovakia
Query!
State/province [209]
0
0
Presov
Query!
Country [210]
0
0
South Africa
Query!
State/province [210]
0
0
Gauteng
Query!
Country [211]
0
0
South Africa
Query!
State/province [211]
0
0
Western Cape
Query!
Country [212]
0
0
Spain
Query!
State/province [212]
0
0
A Coruna
Query!
Country [213]
0
0
Spain
Query!
State/province [213]
0
0
Barcelona
Query!
Country [214]
0
0
Spain
Query!
State/province [214]
0
0
Vizcaya
Query!
Country [215]
0
0
Spain
Query!
State/province [215]
0
0
Madrid
Query!
Country [216]
0
0
Spain
Query!
State/province [216]
0
0
Salamanca
Query!
Country [217]
0
0
Spain
Query!
State/province [217]
0
0
Sevilla
Query!
Country [218]
0
0
Spain
Query!
State/province [218]
0
0
Valencia
Query!
Country [219]
0
0
Spain
Query!
State/province [219]
0
0
Zaragoza
Query!
Country [220]
0
0
Switzerland
Query!
State/province [220]
0
0
Basel-Stadt
Query!
Country [221]
0
0
Switzerland
Query!
State/province [221]
0
0
Zuerich
Query!
Country [222]
0
0
Taiwan
Query!
State/province [222]
0
0
Taichung City
Query!
Country [223]
0
0
Taiwan
Query!
State/province [223]
0
0
Taichung
Query!
Country [224]
0
0
Taiwan
Query!
State/province [224]
0
0
Tainan City
Query!
Country [225]
0
0
Taiwan
Query!
State/province [225]
0
0
Taipei City
Query!
Country [226]
0
0
Ukraine
Query!
State/province [226]
0
0
Uzhhorod
Query!
Country [227]
0
0
Ukraine
Query!
State/province [227]
0
0
????
Query!
Country [228]
0
0
United Kingdom
Query!
State/province [228]
0
0
Scotland
Query!
Country [229]
0
0
United Kingdom
Query!
State/province [229]
0
0
Surrey
Query!
Country [230]
0
0
United Kingdom
Query!
State/province [230]
0
0
Barnsley
Query!
Country [231]
0
0
United Kingdom
Query!
State/province [231]
0
0
Birmingham
Query!
Country [232]
0
0
United Kingdom
Query!
State/province [232]
0
0
Cambridge
Query!
Country [233]
0
0
United Kingdom
Query!
State/province [233]
0
0
Edinburgh
Query!
Country [234]
0
0
United Kingdom
Query!
State/province [234]
0
0
Hull
Query!
Country [235]
0
0
United Kingdom
Query!
State/province [235]
0
0
London
Query!
Country [236]
0
0
United Kingdom
Query!
State/province [236]
0
0
Newcastle Upon Tyne
Query!
Country [237]
0
0
United Kingdom
Query!
State/province [237]
0
0
Oxford
Query!
Country [238]
0
0
United Kingdom
Query!
State/province [238]
0
0
Salford
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The objective of Study M15-991 is to evaluate the efficacy and safety of risankizumab versus placebo during induction therapy in participants with moderately to severely active CD.
Query!
Trial website
https://clinicaltrials.gov/study/NCT03104413
Query!
Trial related presentations / publications
D'Haens G, Panaccione R, Baert F, Bossuyt P, Colombel JF, Danese S, Dubinsky M, Feagan BG, Hisamatsu T, Lim A, Lindsay JO, Loftus EV Jr, Panes J, Peyrin-Biroulet L, Ran Z, Rubin DT, Sandborn WJ, Schreiber S, Neimark E, Song A, Kligys K, Pang Y, Pivorunas V, Berg S, Duan WR, Huang B, Kalabic J, Liao X, Robinson A, Wallace K, Ferrante M. Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. Lancet. 2022 May 28;399(10340):2015-2030. doi: 10.1016/S0140-6736(22)00467-6.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
ABBVIE INC.
Query!
Address
0
0
AbbVie
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
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)
Query!
When will data be available (start and end dates)?
For details on when studies are available for sharing, please refer to the link below.
Query!
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.
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/13/NCT03104413/Prot_001.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/13/NCT03104413/SAP_002.pdf
Informed consent form
https://cdn.clinicaltrials.gov/large-docs/13/NCT03104413/ICF_000.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03104413