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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02407236




Registration number
NCT02407236
Ethics application status
Date submitted
30/03/2015
Date registered
2/04/2015
Date last updated
5/01/2023

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Protocol to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis
Secondary ID [1] 0 0
2014-005606-38
Secondary ID [2] 0 0
CR106920
Universal Trial Number (UTN)
Trial acronym
UNIFI
Linked study record

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

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

Placebo comparator: Induction Study - Placebo Intravenous (IV) - Participants will be randomized to receive single dose of placebo as Intravenous (IV: into the vein) infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study, but will not be randomized.

Experimental: Induction Study - Ustekinumab 130 milligram (mg) IV - Participants will be randomized to receive single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.

Experimental: Induction Study - Ustekinumab 6 mg/kg IV - Participants will be randomized to receive ustekinumab approximating 6 mg/kg of body weight, as intravenous infusion at Week 0. Participants with clinical response at Week 8 will be eligible to enter the Maintenance study and will be randomized.

Other: Induction Study- Placebo- Nonresponsders at Week 8 - Participants without clinical response to placebo at Week 8 will receive a single IV infusion of ustekinumab approximating 6mg/kg along with matching subcutaneous (SC) placebo (to maintain the blind). Participants in clinical response at Week 16 will be eligible to enter Maintenance study and will be randomized.

Other: Induction study-Ustekinumab Nonresponders at Week 8 - Participants without clinical response to ustekinumab (130 mg or 6 mg/kg \[IV\]) at Week 8 will receive a single dose of ustekinumab 90 mg subcutaneously along with matching placebo intravenously (to maintain the blind). Participants in clinical response at Week 16 (that is, delayed responders) will be eligible to enter Maintenance study, but will not be randomized.

Placebo comparator: Maintenance Study - Placebo Subcutaneous (SC) - Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.

Experimental: Maintenance Study - Ustekinumab 90mg SC every 12 weeks - Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 12 weeks, beginning Week 0 of Maintenance study through Week 44.

Experimental: Maintenance Study - Ustekinumab 90mg SC every 8 weeks (q8w) - Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab will be randomized to receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44.

Other: Maintenance Study - Placebo IV - Responder - Placebo SC - Participants in clinical response to Induction treatment with IV Placebo will receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.

Other: Maintenance Study-Delayed Responder-Ustekinumab 90mg SC q8w - Participants without clinical response to induction treatment ustekinumab (130 mg or 6 mg/kg \[IV\]) at Week 8 but in clinical response at Week 16 after receiving Induction Ustekinumab at week 8 (delayed responders) will receive ustekinumab 90 mg subcutaneously every 8 weeks, beginning Week 0 of Maintenance study through Week 44. Participants are not randomized.


Treatment: Drugs: Placebo IV
Placebo will be administered as intravenous infusion.

Treatment: Drugs: Placebo SC
Placebo will be administered Subcutaneously.

Treatment: Drugs: Ustekinumab IV
Ustekinumab will be administered as intravenous infusion at Week 0 or Week 8 in Induction Study.

Treatment: Drugs: Ustekinumab SC
Ustekinumab will be administered as subcutaneously.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)
Timepoint [1] 0 0
Week 8
Primary outcome [2] 0 0
Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition)
Timepoint [2] 0 0
Week 8
Primary outcome [3] 0 0
Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition)
Timepoint [3] 0 0
Week 44
Primary outcome [4] 0 0
Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition)
Timepoint [4] 0 0
Week 44
Secondary outcome [1] 0 0
Induction Study: Number of Participants With Endoscopic Healing at Week 8
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Induction Study: Number of Participants With Clinical Response at Week 8
Timepoint [2] 0 0
Week 8
Secondary outcome [3] 0 0
Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Timepoint [3] 0 0
Baseline and Week 8
Secondary outcome [4] 0 0
Maintenance Study: Number of Participants With Clinical Response up to Week 44
Timepoint [4] 0 0
Up to Week 44
Secondary outcome [5] 0 0
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44
Timepoint [5] 0 0
Week 44
Secondary outcome [6] 0 0
Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition)
Timepoint [6] 0 0
Week 44
Secondary outcome [7] 0 0
Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition)
Timepoint [7] 0 0
Week 44
Secondary outcome [8] 0 0
Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per Global Definition)
Timepoint [8] 0 0
Up to Week 44
Secondary outcome [9] 0 0
Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per US Definition)
Timepoint [9] 0 0
Up to Week 44
Secondary outcome [10] 0 0
Induction Study - Number of Participants With Mucosal Healing at Week 8
Timepoint [10] 0 0
Week 8
Secondary outcome [11] 0 0
Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition)
Timepoint [11] 0 0
Week 8
Secondary outcome [12] 0 0
Induction Study - Number of Participants in Symptomatic Remission at Week 8
Timepoint [12] 0 0
Week 8
Secondary outcome [13] 0 0
Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8
Timepoint [13] 0 0
Week 8
Secondary outcome [14] 0 0
Induction Study - Change From Baseline in Mayo Score at Week 8
Timepoint [14] 0 0
Baseline and Week 8
Secondary outcome [15] 0 0
Induction Study - Change From Baseline in Partial Mayo Score Through Week 8
Timepoint [15] 0 0
Baseline through Week 8
Secondary outcome [16] 0 0
Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8
Timepoint [16] 0 0
Up to Week 8
Secondary outcome [17] 0 0
Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8
Timepoint [17] 0 0
Up to Week 8
Secondary outcome [18] 0 0
Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8
Timepoint [18] 0 0
Week 8
Secondary outcome [19] 0 0
Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8
Timepoint [19] 0 0
Up to Week 8
Secondary outcome [20] 0 0
Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition)
Timepoint [20] 0 0
Week 8
Secondary outcome [21] 0 0
Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition)
Timepoint [21] 0 0
Week 8
Secondary outcome [22] 0 0
Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status
Timepoint [22] 0 0
Week 8
Secondary outcome [23] 0 0
Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status
Timepoint [23] 0 0
Week 8
Secondary outcome [24] 0 0
Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)
Timepoint [24] 0 0
Week 8
Secondary outcome [25] 0 0
Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)
Timepoint [25] 0 0
Week 8
Secondary outcome [26] 0 0
Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8
Timepoint [26] 0 0
Baseline through Week 8
Secondary outcome [27] 0 0
Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline
Timepoint [27] 0 0
Up to Week 8
Secondary outcome [28] 0 0
Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8
Timepoint [28] 0 0
Baseline through Week 8
Secondary outcome [29] 0 0
Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline
Timepoint [29] 0 0
Up to Week 8
Secondary outcome [30] 0 0
Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8
Timepoint [30] 0 0
Baseline through Week 8
Secondary outcome [31] 0 0
Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline
Timepoint [31] 0 0
Up to Week 8
Secondary outcome [32] 0 0
Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Timepoint [32] 0 0
Baseline and Week 8
Secondary outcome [33] 0 0
Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8
Timepoint [33] 0 0
Baseline and Week 8
Secondary outcome [34] 0 0
Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8
Timepoint [34] 0 0
Baseline and Week 8
Secondary outcome [35] 0 0
Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8
Timepoint [35] 0 0
Baseline and Week 8
Secondary outcome [36] 0 0
Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8
Timepoint [36] 0 0
Baseline and Week 8
Secondary outcome [37] 0 0
Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8
Timepoint [37] 0 0
Baseline and Week 8
Secondary outcome [38] 0 0
Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8
Timepoint [38] 0 0
Baseline and Week 8
Secondary outcome [39] 0 0
Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44
Timepoint [39] 0 0
Baseline and Week 44
Secondary outcome [40] 0 0
Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44
Timepoint [40] 0 0
Induction Baseline and Week 44
Secondary outcome [41] 0 0
Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44
Timepoint [41] 0 0
Up to Week 44
Secondary outcome [42] 0 0
Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44
Timepoint [42] 0 0
Up to Week 44
Secondary outcome [43] 0 0
Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44
Timepoint [43] 0 0
Week 44
Secondary outcome [44] 0 0
Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44
Timepoint [44] 0 0
Up to Week 44
Secondary outcome [45] 0 0
Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44
Timepoint [45] 0 0
Baseline through Week 44
Secondary outcome [46] 0 0
Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44
Timepoint [46] 0 0
Baseline through Week 44
Secondary outcome [47] 0 0
Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44
Timepoint [47] 0 0
Week 44
Secondary outcome [48] 0 0
Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44
Timepoint [48] 0 0
Week 44
Secondary outcome [49] 0 0
Maintenance Study: Number of Participants in Symptomatic Remission at Week 44
Timepoint [49] 0 0
Week 44
Secondary outcome [50] 0 0
Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition)
Timepoint [50] 0 0
Week 44
Secondary outcome [51] 0 0
Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition)
Timepoint [51] 0 0
Week 44
Secondary outcome [52] 0 0
Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status
Timepoint [52] 0 0
Up to Week 44
Secondary outcome [53] 0 0
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status
Timepoint [53] 0 0
Week 44
Secondary outcome [54] 0 0
Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline
Timepoint [54] 0 0
Week 44
Secondary outcome [55] 0 0
Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44
Timepoint [55] 0 0
Week 44
Secondary outcome [56] 0 0
Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per Global Definition)
Timepoint [56] 0 0
Week 44
Secondary outcome [57] 0 0
Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per US Definition)
Timepoint [57] 0 0
Week 44
Secondary outcome [58] 0 0
MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline
Timepoint [58] 0 0
Baseline Through Week 44
Secondary outcome [59] 0 0
Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline
Timepoint [59] 0 0
Week 44
Secondary outcome [60] 0 0
Maintenance Study: Number of Participants Who Maintained 20-point Improvement From Induction Baseline in IBDQ up to Week 44 Among Participants With a >20-point Improvement in IBDQ at Maintenance Baseline
Timepoint [60] 0 0
Up to Week 44
Secondary outcome [61] 0 0
Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44
Timepoint [61] 0 0
Baseline, Week 20, and 44
Secondary outcome [62] 0 0
Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44
Timepoint [62] 0 0
Baseline, Week 20, and 44
Secondary outcome [63] 0 0
Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44
Timepoint [63] 0 0
Baseline, Weeks 20, and 44
Secondary outcome [64] 0 0
Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44
Timepoint [64] 0 0
Baseline, Weeks 20, and 44
Secondary outcome [65] 0 0
Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44
Timepoint [65] 0 0
Baseline, Weeks 20, and 44
Secondary outcome [66] 0 0
Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44
Timepoint [66] 0 0
Baseline, Weeks 20 and 44
Secondary outcome [67] 0 0
Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44
Timepoint [67] 0 0
Baseline, Weeks 20, and 44
Secondary outcome [68] 0 0
Maintenance Study: Number of Participants With Mucosal Healing at Week 44
Timepoint [68] 0 0
Week 44
Secondary outcome [69] 0 0
Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44
Timepoint [69] 0 0
Baseline, Weeks 8, 24, and 44
Secondary outcome [70] 0 0
Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44
Timepoint [70] 0 0
Baseline, Weeks 8, 24, and 44
Secondary outcome [71] 0 0
Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44
Timepoint [71] 0 0
Baseline, Weeks 8, 24, and 44

Eligibility
Key inclusion criteria
* Has a clinical diagnosis of Ulcerative Colitis (UC) at least 3 months before Screening
* Has moderately to severely active UC, defined as a Baseline (Week 0) Mayo score of 6 to 12, including a Screening endoscopy subscore of the Mayo score greater than or equal to (>=) 2 as determined by a central reading of the video endoscopy
* Have failed biologic therapy, that is, have received treatment with 1 or more tumour necrosis factor (TNF) antagonists or vedolizumab at a dose approved for the treatment of UC, and have a documented history of failure to respond to or tolerate such treatment; OR Be naïve to biologic therapy (TNF antagonists or vedolizumab) or have received biologic therapy but have not demonstrated a history of failure to respond to, or tolerate, a biologic therapy and have a prior or current UC medication history that includes at least 1 of the following: a. Inadequate response to or failure to tolerate current treatment with oral corticosteroids or immunomodulators (6-mercaptopurine [6-MP] or azathioprine [AZA]) OR b. History of failure to respond to, or tolerate, at least 1 of the following therapies: oral or IV corticosteroids or immunomodulators (6-MP or AZA) OR c. History of corticosteroid dependence (that is, an inability to successfully taper corticosteroids without a return of the symptoms of UC)
* Before the first administration of study agent, the following conditions must be met: vedolizumab must have been discontinued for at least 4 months and anti-tumor necrosis factors (TNFs) for at least 8 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has severe extensive colitis and is at imminent risk of colectomy
* Has UC limited to the rectum only or to < 20 centimeters (cm) of the colon
* Presence of a stoma or history of a fistula
* Participants with history of extensive colonic resection (for example, less than 30 cm of colon remaining) that would prevent adequate evaluation of the effect of study agent on clinical disease activity
* Participants with history of colonic mucosal dysplasia. Participants will not be excluded from the study because of a pathology finding of "indefinite dysplasia with reactive atypia''

Study design
Purpose of the study
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
10/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/11/2021
Sample size
Target
Accrual to date
Final
961
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Bedford
Recruitment hospital [2] 0 0
- Clayton
Recruitment hospital [3] 0 0
- Concord N/a
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment hospital [5] 0 0
- Five Dock
Recruitment hospital [6] 0 0
- Garran
Recruitment hospital [7] 0 0
- Heidelberg
Recruitment hospital [8] 0 0
- Liverpool
Recruitment hospital [9] 0 0
- Melbourne
Recruitment hospital [10] 0 0
- South Brisbane
Recruitment postcode(s) [1] 0 0
- Bedford
Recruitment postcode(s) [2] 0 0
- Clayton
Recruitment postcode(s) [3] 0 0
- Concord N/a
Recruitment postcode(s) [4] 0 0
- Fitzroy
Recruitment postcode(s) [5] 0 0
- Five Dock
Recruitment postcode(s) [6] 0 0
- Garran
Recruitment postcode(s) [7] 0 0
- Heidelberg
Recruitment postcode(s) [8] 0 0
- Liverpool
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- South Brisbane
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
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
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
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Kentucky
Country [13] 0 0
United States of America
State/province [13] 0 0
Louisiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
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
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
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
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Utah
Country [27] 0 0
United States of America
State/province [27] 0 0
Virginia
Country [28] 0 0
United States of America
State/province [28] 0 0
Washington
Country [29] 0 0
Austria
State/province [29] 0 0
Salzburg
Country [30] 0 0
Austria
State/province [30] 0 0
Wien
Country [31] 0 0
Belgium
State/province [31] 0 0
Antwerpen
Country [32] 0 0
Belgium
State/province [32] 0 0
Gent
Country [33] 0 0
Belgium
State/province [33] 0 0
Kortrijk
Country [34] 0 0
Belgium
State/province [34] 0 0
Leuven
Country [35] 0 0
Belgium
State/province [35] 0 0
Liege
Country [36] 0 0
Belgium
State/province [36] 0 0
Liège
Country [37] 0 0
Belgium
State/province [37] 0 0
Roeselaere
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Pleven
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Rousse
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Sevlievo
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Sofia
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Varna
Country [43] 0 0
Canada
State/province [43] 0 0
British Columbia
Country [44] 0 0
Canada
State/province [44] 0 0
Manitoba
Country [45] 0 0
Canada
State/province [45] 0 0
Ontario
Country [46] 0 0
Canada
State/province [46] 0 0
Quebec
Country [47] 0 0
Czechia
State/province [47] 0 0
Hradec Kralove
Country [48] 0 0
Czechia
State/province [48] 0 0
Plzen
Country [49] 0 0
Czechia
State/province [49] 0 0
Prague 4
Country [50] 0 0
Czechia
State/province [50] 0 0
Praha 5
Country [51] 0 0
Czechia
State/province [51] 0 0
Praha 7
Country [52] 0 0
Czechia
State/province [52] 0 0
Praha 9
Country [53] 0 0
Denmark
State/province [53] 0 0
Aarhus
Country [54] 0 0
Denmark
State/province [54] 0 0
Odense
Country [55] 0 0
France
State/province [55] 0 0
Amiens
Country [56] 0 0
France
State/province [56] 0 0
Bordeaux
Country [57] 0 0
France
State/province [57] 0 0
Lille
Country [58] 0 0
France
State/province [58] 0 0
Lyon
Country [59] 0 0
France
State/province [59] 0 0
Marseille
Country [60] 0 0
France
State/province [60] 0 0
Montpellier
Country [61] 0 0
France
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Japan
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Sutton In Ashfield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02407236