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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02596893
Registration number
NCT02596893
Ethics application status
Date submitted
3/11/2015
Date registered
4/11/2015
Date last updated
28/08/2019
Titles & IDs
Public title
Efficacy and Safety Study of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
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Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Investigate the Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Subjects With Active Crohn's Disease
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Secondary ID [1]
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GED-0301-CD-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn Disease
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Inflammatory bowel disease
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
0
0
0
0
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GED-0301
Treatment: Drugs - Placebo
Experimental: GED0301 160mg x 12 weeks followed by periodic 160 mg GED0301 - GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 160 mg QD for 4 weeks and placebo QD for 4 weeks, until the the Week 52 Visit
Experimental: GED0301 160mg x 12 weeks followed by periodic GED0301 40mg - GED-0301 160 mg once daily (QD) for 12 weeks; followed by placebo QD for 4 weeks; followed by alternating GED-0301 40 mg QD for 4 weeks and placebo QD for 4 weeks, until the Week 52 Visit
Experimental: GED0301 160mg x 12 weeks followed by continuous GED0301 40mg - GED-0301 160 mg once daily (QD) for 12 weeks; followed by continuous GED-0301 40 mg QD, until the Week 52 Visit
Placebo Comparator: Placebo - Placebo once daily (QD) until the Week 52 Visit
Treatment: Drugs: GED-0301
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The Percentage of Participants Who Achieved a Clinical Remission at Week 12
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Assessment method [1]
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Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the affect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants Who Achieved Clinical Remission at Week 52
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Assessment method [1]
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Clinical remission is defined as a CDAI score < 150 and is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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Timepoint [1]
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Week 52
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Secondary outcome [2]
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Percentage of Participants With Endoscopic Response-50 Centrally Read at Week 52
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Assessment method [2]
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An endoscopic response-50 is defined as a reduction of at least 50% compared with baseline in simple endoscopic score for Crohn's Disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:
Ulcers scored as:
0: no
aphthous (0.1-0.5 cm)
large (0.5-2 cm)
very large (>2 cm)
Surface involved disease 0: 0%
<50%
50-75%
>75%
Surface involved by ulcerations:
0: 0%
<10%
10-30%
>30% - Narrowings:
0: No
Single, can be passed
Multiple, can be passed
Cannot be passed Grand Total = SES-CD score
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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The Percentage of Participants Who Achieved a Clinical Response at Week 12
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Assessment method [3]
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A clinical response is defined as a CDAI score decrease from baseline = 100 points. The CDAI is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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The Percentage of Participants Who Achieved a Clinical Response at Week 4
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Assessment method [4]
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A clinical response is defined as a decrease from baseline in CDAI = 100 points. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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Timepoint [4]
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Week 4
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Secondary outcome [5]
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The Percentage of Participants Who Achieved a Clinical Remission at Week 4
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Assessment method [5]
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A clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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Timepoint [5]
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Week 4
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Secondary outcome [6]
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The Percentage of Participants Who Achieved a Corticosteroid-Free Clinical Remission at Week 52
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Assessment method [6]
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The percentage of participants who were receiving oral corticosteroids for Crohn's disease, at baseline and achieved a clinical remission (CDAI score <150) at Week 52 without corticosteroids. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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Timepoint [6]
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Week 52
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Secondary outcome [7]
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Percentage of Participants Who Achieved a Sustained Clinical Remission at Both Week 12 and 52
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Assessment method [7]
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For participants who achieved a sustained clinical remission at both week 12 and 52, the clinical remission is a CDAI score < 150. The Crohn's Disease Activity Index is used to quantify the signs and symptoms of Crohn's disease and the effect on patient's quality of life. It consists of 8 variables which include patient reported outcomes over a 7 day period and physician assessments which are scored numerically and weighted. Scores range from 0 to 600, with the most severe disease defined >450.
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Timepoint [7]
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Weeks 12 and 52
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Secondary outcome [8]
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Percentage of Participants With Endoscopic Response-25 Centrally Read at Week 12
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Assessment method [8]
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An endoscopic response-25 is defined as a reduction of at least 25% compared with baseline in simple endoscopic score for Crohn's disease (SES-CD). The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:
Ulcers scored as:
0: no
aphthous (0.1-0.5 cm)
large (0.5-2 cm)
very large (>2 cm)
Surface involved disease 0: 0%
<50%
50-75%
>75%
Surface involved by ulcerations:
0: 0%
<10%
10-30%
>30% - Narrowings:
0: No
Single, can be passed
Multiple, can be passed
Cannot be passed Grand Total = SES-CD score
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Timepoint [8]
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0
Week 0, Week 12
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Secondary outcome [9]
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Percentage of Participants With Endoscopic Remission Centrally Read at Week 52
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Assessment method [9]
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Endoscopic remission is defined as a simple endoscopic score for Crohn's disease (SES-CD) of =2 at the specified timeframe. The SES-CD assesses the size of mucosal ulcers, the extent of ulcerated surface, the extent of affected surface, and the presence and type of narrowings. Scores range from 0 to 60 with higher scores reflecting more severe disease. The SES-CD calculations include:
Ulcers scored as:
0: no
aphthous (0.1-0.5 cm)
large (0.5-2 cm)
very large (>2 cm)
Surface involved disease 0: 0%
<50%
50-75%
>75%
Surface involved by ulcerations:
0: 0%
<10%
10-30%
>30% - Narrowings:
0: No
Single, can be passed
Multiple, can be passed
Cannot be passed Grand Total = SES-CD score
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Timepoint [9]
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Week 52
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Secondary outcome [10]
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The Number of Participants Who Experienced Treatment Emergent Adverse Events (TEAE) From Week 0 to Week 52
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Assessment method [10]
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A TEAE was defined as any adverse event (AE) occurring or worsening on or after the first treatment of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event.
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Timepoint [10]
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From the first day of GED-0301 until 28 days after the last dose of investigational product (IP); maximum treatment duration was 52.6 weeks
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Secondary outcome [11]
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The Number of Participants Who Discontinued IP Due to an Treatment Emergent Adverse Events
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Assessment method [11]
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A TEAE was defined as any AE occurring or worsening on or after the first dose of GED-0301 and up to 28 days after the last GED-0301 dose or the last follow-up date, whichever occurred earlier. A serious AE = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; constitutes an important medical event. The severity of AEs was assessed by the investigator and based on the following scale: Mild = asymptomatic or mild symptoms; clinical or diagnostic observations only; Moderate = Symptoms cause moderate discomfort; Severe (could be non-serious or serious) = symptoms causing severe discomfort/pain.
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Timepoint [11]
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From the first day of GED-0301 until 28 days after the last dose of IP; maximum treatment duration was 52.6 weeks
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Eligibility
Key inclusion criteria
Subjects must satisfy the following criteria to be enrolled in the study:
- Male or female = 18 years
- Active Crohn's disease (CD) disease as determined by the Crohn's Disease Activity
Index (CDAI) score and the Simple Endoscopic Score for Crohn's Disease (SES-CD)
- Must meet a determined average minimum number of daily stools or rating of abdominal
pain over a 7 day period
- Subject must have failed or experienced intolerance to at least one of the following:
budesonide; systemic corticosteroids; immunosuppressants (eg, azathiopurine,
6-mercaptopurine, or methotrexate); or biologics for the treatment of CD.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
The presence of any of the following will exclude a subject from enrollment:
- Diagnosis of ulcerative colitis (UC), indeterminate colitis, ischemic colitis,
microscopic colitis, radiation colitis or diverticular disease-associated colitis
- Local manifestations of Crohn's Disease (CD) such as symptomatic/severe strictures,
abscesses, short bowel syndrome; or other disease complications for which surgery
might be indicated or could confound the evaluation of efficacy
- Intestinal resection within 6 months or any intra-abdominal surgery within 3 months
prior to the Screening Visit
- Ileostomy or a colostomy
- Subject has a history of any clinically significant medical condition that, in the
investigator's opinion, would prevent the subject from participating in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/12/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/01/2018
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Sample size
Target
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Accrual to date
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Final
701
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Bankstown-Lidcombe Hospital - Bankstown
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Recruitment hospital [2]
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Royal Prince Alfred Hospital - Camperdown
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Concord Repatriation General Hospital - Concord
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Centre For Digestive Diseases - Five Dock
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Recruitment hospital [5]
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Liverpool Hospital - Liverpool
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Mater Adult Hospital - South Brisbane
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [8]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [9]
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Flinders Medical Centre - Bedford Park
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Box Hill Hospital - Box Hill
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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Ballarat Base Hospital - Ballarat
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Monash Medical Centre Clayton - Bentleigh East
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St Vincents Hospital Melbourne - Fitzroy
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Austin Hospital - Heidelberg
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Royal Brisbane and Women's Hospital - Herston
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Recruitment hospital [18]
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Nepean Hospital - Kingswood, NSW
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2139 - Concord
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2046 - Five Dock
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Recruitment postcode(s) [5]
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2170 - Liverpool
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Recruitment postcode(s) [6]
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4101 - South Brisbane
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Recruitment postcode(s) [7]
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4102 - Woolloongabba
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Recruitment postcode(s) [8]
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5000 - Adelaide
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Recruitment postcode(s) [9]
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5042 - Bedford Park
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Recruitment postcode(s) [10]
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3128 - Box Hill
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Recruitment postcode(s) [11]
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3004 - Melbourne
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Recruitment postcode(s) [12]
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6150 - Murdoch
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3350 - Ballarat
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Recruitment postcode(s) [14]
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3165 - Bentleigh East
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3065 - Fitzroy
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3084 - Heidelberg
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4006 - Herston
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Recruitment postcode(s) [18]
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2751 - Kingswood, NSW
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Recruitment outside Australia
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Linz
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Austria
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Wein
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Ruse
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Manitoba
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Osijek
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Croatia
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Brno
Query!
Country [65]
0
0
Czechia
Query!
State/province [65]
0
0
Hradec Kralove
Query!
Country [66]
0
0
Czechia
Query!
State/province [66]
0
0
Most
Query!
Country [67]
0
0
Czechia
Query!
State/province [67]
0
0
Olomouc
Query!
Country [68]
0
0
Czechia
Query!
State/province [68]
0
0
Pardubice
Query!
Country [69]
0
0
Czechia
Query!
State/province [69]
0
0
Praha 3
Query!
Country [70]
0
0
Czechia
Query!
State/province [70]
0
0
Praha 7
Query!
Country [71]
0
0
Czechia
Query!
State/province [71]
0
0
Usti nad Labem
Query!
Country [72]
0
0
Czechia
Query!
State/province [72]
0
0
Znojmo
Query!
Country [73]
0
0
Denmark
Query!
State/province [73]
0
0
Aahus C
Query!
Country [74]
0
0
Denmark
Query!
State/province [74]
0
0
Frederikssund
Query!
Country [75]
0
0
Denmark
Query!
State/province [75]
0
0
Herlev
Query!
Country [76]
0
0
Denmark
Query!
State/province [76]
0
0
Hvidovre
Query!
Country [77]
0
0
Denmark
Query!
State/province [77]
0
0
Koge
Query!
Country [78]
0
0
Denmark
Query!
State/province [78]
0
0
Silkeborg
Query!
Country [79]
0
0
Denmark
Query!
State/province [79]
0
0
Ålborg
Query!
Country [80]
0
0
Estonia
Query!
State/province [80]
0
0
Tallinn
Query!
Country [81]
0
0
Estonia
Query!
State/province [81]
0
0
Tartu
Query!
Country [82]
0
0
Finland
Query!
State/province [82]
0
0
Tampere
Query!
Country [83]
0
0
Finland
Query!
State/province [83]
0
0
Turku
Query!
Country [84]
0
0
France
Query!
State/province [84]
0
0
Amiens Cedex
Query!
Country [85]
0
0
France
Query!
State/province [85]
0
0
Besancon Cedex
Query!
Country [86]
0
0
France
Query!
State/province [86]
0
0
Chambray les Tours
Query!
Country [87]
0
0
France
Query!
State/province [87]
0
0
Clermont-Ferrand
Query!
Country [88]
0
0
France
Query!
State/province [88]
0
0
Clichy cedex
Query!
Country [89]
0
0
France
Query!
State/province [89]
0
0
Dijon
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Grenoble cedex 9
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Le Kremlin Bicetre cedex
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Lille cedex
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Marseille cedex 20
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Nantes Cedex 1
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Nice Cedex 3
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Paris
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Pessac
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Pierre-Bénite Cedex
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Reims
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Rennes cedex 09
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Rouen Cedex
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Saint Etienne
Query!
Country [103]
0
0
France
Query!
State/province [103]
0
0
Strasbourg Cedex
Query!
Country [104]
0
0
France
Query!
State/province [104]
0
0
Toulouse Cedex 09
Query!
Country [105]
0
0
France
Query!
State/province [105]
0
0
Vandoeuvre les Nancy
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Berlin
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Bochum
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Brandenburg an der Havel
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Dresden
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Duesseldorf
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Erlangen
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Essen
Query!
Country [113]
0
0
Germany
Query!
State/province [113]
0
0
Frankfurt
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
Halle
Query!
Country [116]
0
0
Germany
Query!
State/province [116]
0
0
Hamburg
Query!
Country [117]
0
0
Germany
Query!
State/province [117]
0
0
Hannover
Query!
Country [118]
0
0
Germany
Query!
State/province [118]
0
0
Heidelberg
Query!
Country [119]
0
0
Germany
Query!
State/province [119]
0
0
Jena
Query!
Country [120]
0
0
Germany
Query!
State/province [120]
0
0
Kiel
Query!
Country [121]
0
0
Germany
Query!
State/province [121]
0
0
Leipzig
Query!
Country [122]
0
0
Germany
Query!
State/province [122]
0
0
Lueneburg
Query!
Country [123]
0
0
Germany
Query!
State/province [123]
0
0
Magdeburg
Query!
Country [124]
0
0
Germany
Query!
State/province [124]
0
0
Mannheim
Query!
Country [125]
0
0
Germany
Query!
State/province [125]
0
0
Minden
Query!
Country [126]
0
0
Germany
Query!
State/province [126]
0
0
Muenchen
Query!
Country [127]
0
0
Germany
Query!
State/province [127]
0
0
Muenster
Query!
Country [128]
0
0
Germany
Query!
State/province [128]
0
0
München
Query!
Country [129]
0
0
Germany
Query!
State/province [129]
0
0
Niedersachsen
Query!
Country [130]
0
0
Germany
Query!
State/province [130]
0
0
Regensburg
Query!
Country [131]
0
0
Germany
Query!
State/province [131]
0
0
Ulm
Query!
Country [132]
0
0
Greece
Query!
State/province [132]
0
0
Alexandroupolis
Query!
Country [133]
0
0
Greece
Query!
State/province [133]
0
0
Athens
Query!
Country [134]
0
0
Greece
Query!
State/province [134]
0
0
Heraklion
Query!
Country [135]
0
0
Greece
Query!
State/province [135]
0
0
Ioannina
Query!
Country [136]
0
0
Greece
Query!
State/province [136]
0
0
Rio Patras
Query!
Country [137]
0
0
Greece
Query!
State/province [137]
0
0
Thessaloniki
Query!
Country [138]
0
0
Hungary
Query!
State/province [138]
0
0
Balatonfured
Query!
Country [139]
0
0
Hungary
Query!
State/province [139]
0
0
Budapest
Query!
Country [140]
0
0
Hungary
Query!
State/province [140]
0
0
Debrecen
Query!
Country [141]
0
0
Hungary
Query!
State/province [141]
0
0
Dunaujvaros
Query!
Country [142]
0
0
Hungary
Query!
State/province [142]
0
0
Eger
Query!
Country [143]
0
0
Hungary
Query!
State/province [143]
0
0
Gyor
Query!
Country [144]
0
0
Hungary
Query!
State/province [144]
0
0
Gyula
Query!
Country [145]
0
0
Hungary
Query!
State/province [145]
0
0
Kaposvar
Query!
Country [146]
0
0
Hungary
Query!
State/province [146]
0
0
Mohacs
Query!
Country [147]
0
0
Hungary
Query!
State/province [147]
0
0
Nyiregyhaza
Query!
Country [148]
0
0
Hungary
Query!
State/province [148]
0
0
Szeged
Query!
Country [149]
0
0
Hungary
Query!
State/province [149]
0
0
Szekesfehervar
Query!
Country [150]
0
0
Hungary
Query!
State/province [150]
0
0
Szekszard
Query!
Country [151]
0
0
Israel
Query!
State/province [151]
0
0
Afula
Query!
Country [152]
0
0
Israel
Query!
State/province [152]
0
0
Beer Sheva
Query!
Country [153]
0
0
Israel
Query!
State/province [153]
0
0
Haifa
Query!
Country [154]
0
0
Israel
Query!
State/province [154]
0
0
Holon
Query!
Country [155]
0
0
Israel
Query!
State/province [155]
0
0
Jerusalem
Query!
Country [156]
0
0
Israel
Query!
State/province [156]
0
0
Petah Tikva
Query!
Country [157]
0
0
Israel
Query!
State/province [157]
0
0
Ramat Gan
Query!
Country [158]
0
0
Israel
Query!
State/province [158]
0
0
Rechovot
Query!
Country [159]
0
0
Israel
Query!
State/province [159]
0
0
Tel Aviv
Query!
Country [160]
0
0
Israel
Query!
State/province [160]
0
0
Zerifin
Query!
Country [161]
0
0
Italy
Query!
State/province [161]
0
0
Bari
Query!
Country [162]
0
0
Italy
Query!
State/province [162]
0
0
Bologna
Query!
Country [163]
0
0
Italy
Query!
State/province [163]
0
0
Messina
Query!
Country [164]
0
0
Italy
Query!
State/province [164]
0
0
Milano
Query!
Country [165]
0
0
Italy
Query!
State/province [165]
0
0
Naples
Query!
Country [166]
0
0
Italy
Query!
State/province [166]
0
0
Napoli, Campania
Query!
Country [167]
0
0
Italy
Query!
State/province [167]
0
0
Padova
Query!
Country [168]
0
0
Italy
Query!
State/province [168]
0
0
Palermo
Query!
Country [169]
0
0
Italy
Query!
State/province [169]
0
0
Pavia
Query!
Country [170]
0
0
Italy
Query!
State/province [170]
0
0
Pisa
Query!
Country [171]
0
0
Italy
Query!
State/province [171]
0
0
Roma
Query!
Country [172]
0
0
Italy
Query!
State/province [172]
0
0
Rome
Query!
Country [173]
0
0
Italy
Query!
State/province [173]
0
0
Rozzano (MI)
Query!
Country [174]
0
0
Italy
Query!
State/province [174]
0
0
Salerno
Query!
Country [175]
0
0
Italy
Query!
State/province [175]
0
0
San Donato Milanese
Query!
Country [176]
0
0
Italy
Query!
State/province [176]
0
0
San Giovanni Rotondo FG
Query!
Country [177]
0
0
Korea, Republic of
Query!
State/province [177]
0
0
Busan
Query!
Country [178]
0
0
Korea, Republic of
Query!
State/province [178]
0
0
Daegu
Query!
Country [179]
0
0
Korea, Republic of
Query!
State/province [179]
0
0
Guri-si
Query!
Country [180]
0
0
Korea, Republic of
Query!
State/province [180]
0
0
Seongnam-si,
Query!
Country [181]
0
0
Korea, Republic of
Query!
State/province [181]
0
0
Seongnam-si
Query!
Country [182]
0
0
Korea, Republic of
Query!
State/province [182]
0
0
Seoul
Query!
Country [183]
0
0
Korea, Republic of
Query!
State/province [183]
0
0
Suwon-si
Query!
Country [184]
0
0
Latvia
Query!
State/province [184]
0
0
Riga
Query!
Country [185]
0
0
Malaysia
Query!
State/province [185]
0
0
Kedah
Query!
Country [186]
0
0
Malaysia
Query!
State/province [186]
0
0
Kelantan
Query!
Country [187]
0
0
Malaysia
Query!
State/province [187]
0
0
Selangor
Query!
Country [188]
0
0
Malaysia
Query!
State/province [188]
0
0
Wilayah Persekutuan Kuala Lumpur
Query!
Country [189]
0
0
Netherlands
Query!
State/province [189]
0
0
Amsterdam
Query!
Country [190]
0
0
Netherlands
Query!
State/province [190]
0
0
Breda
Query!
Country [191]
0
0
Netherlands
Query!
State/province [191]
0
0
Groningen
Query!
Country [192]
0
0
Netherlands
Query!
State/province [192]
0
0
Leiden
Query!
Country [193]
0
0
Netherlands
Query!
State/province [193]
0
0
Leidschendam
Query!
Country [194]
0
0
Netherlands
Query!
State/province [194]
0
0
Nijmegen
Query!
Country [195]
0
0
Netherlands
Query!
State/province [195]
0
0
Sittard-Geleen
Query!
Country [196]
0
0
Netherlands
Query!
State/province [196]
0
0
Tilburg
Query!
Country [197]
0
0
Netherlands
Query!
State/province [197]
0
0
Utrecht
Query!
Country [198]
0
0
New Zealand
Query!
State/province [198]
0
0
Hamilton
Query!
Country [199]
0
0
Norway
Query!
State/province [199]
0
0
Fredrikstad
Query!
Country [200]
0
0
Norway
Query!
State/province [200]
0
0
Lørenskog
Query!
Country [201]
0
0
Norway
Query!
State/province [201]
0
0
Oslo
Query!
Country [202]
0
0
Norway
Query!
State/province [202]
0
0
Stavanger
Query!
Country [203]
0
0
Poland
Query!
State/province [203]
0
0
Bialystok
Query!
Country [204]
0
0
Poland
Query!
State/province [204]
0
0
Bydgoszcz
Query!
Country [205]
0
0
Poland
Query!
State/province [205]
0
0
Gdansk
Query!
Country [206]
0
0
Poland
Query!
State/province [206]
0
0
Kielce
Query!
Country [207]
0
0
Poland
Query!
State/province [207]
0
0
Knurow
Query!
Country [208]
0
0
Poland
Query!
State/province [208]
0
0
Krakow
Query!
Country [209]
0
0
Poland
Query!
State/province [209]
0
0
Lodz
Query!
Country [210]
0
0
Poland
Query!
State/province [210]
0
0
Lublin
Query!
Country [211]
0
0
Poland
Query!
State/province [211]
0
0
Poznan
Query!
Country [212]
0
0
Poland
Query!
State/province [212]
0
0
Rzeszow
Query!
Country [213]
0
0
Poland
Query!
State/province [213]
0
0
Sopot
Query!
Country [214]
0
0
Poland
Query!
State/province [214]
0
0
Warsaw
Query!
Country [215]
0
0
Poland
Query!
State/province [215]
0
0
Wroclaw
Query!
Country [216]
0
0
Portugal
Query!
State/province [216]
0
0
Braga
Query!
Country [217]
0
0
Portugal
Query!
State/province [217]
0
0
Coimbra
Query!
Country [218]
0
0
Portugal
Query!
State/province [218]
0
0
Guimaraes
Query!
Country [219]
0
0
Portugal
Query!
State/province [219]
0
0
Lisboa
Query!
Country [220]
0
0
Portugal
Query!
State/province [220]
0
0
Porto
Query!
Country [221]
0
0
Portugal
Query!
State/province [221]
0
0
Viana do Castelo
Query!
Country [222]
0
0
Romania
Query!
State/province [222]
0
0
Bucuresti
Query!
Country [223]
0
0
Romania
Query!
State/province [223]
0
0
Cluj Napoca
Query!
Country [224]
0
0
Romania
Query!
State/province [224]
0
0
Iasi
Query!
Country [225]
0
0
Romania
Query!
State/province [225]
0
0
Oradea
Query!
Country [226]
0
0
Romania
Query!
State/province [226]
0
0
Timisoara
Query!
Country [227]
0
0
Russian Federation
Query!
State/province [227]
0
0
Irkutsk
Query!
Country [228]
0
0
Russian Federation
Query!
State/province [228]
0
0
Krasnoyarsk
Query!
Country [229]
0
0
Russian Federation
Query!
State/province [229]
0
0
Moscow
Query!
Country [230]
0
0
Russian Federation
Query!
State/province [230]
0
0
Nizhny Novgorod
Query!
Country [231]
0
0
Russian Federation
Query!
State/province [231]
0
0
Novosibirsk
Query!
Country [232]
0
0
Russian Federation
Query!
State/province [232]
0
0
Omsk
Query!
Country [233]
0
0
Russian Federation
Query!
State/province [233]
0
0
Perm
Query!
Country [234]
0
0
Russian Federation
Query!
State/province [234]
0
0
Pushkin
Query!
Country [235]
0
0
Russian Federation
Query!
State/province [235]
0
0
Rostov-on-Don
Query!
Country [236]
0
0
Russian Federation
Query!
State/province [236]
0
0
Saint-Petersburg
Query!
Country [237]
0
0
Russian Federation
Query!
State/province [237]
0
0
Samara
Query!
Country [238]
0
0
Russian Federation
Query!
State/province [238]
0
0
Saratov
Query!
Country [239]
0
0
Russian Federation
Query!
State/province [239]
0
0
Tosno
Query!
Country [240]
0
0
Russian Federation
Query!
State/province [240]
0
0
Yaroslavl
Query!
Country [241]
0
0
Serbia
Query!
State/province [241]
0
0
Belgrade
Query!
Country [242]
0
0
Serbia
Query!
State/province [242]
0
0
Kragujevac
Query!
Country [243]
0
0
Serbia
Query!
State/province [243]
0
0
Nis
Query!
Country [244]
0
0
Slovakia
Query!
State/province [244]
0
0
Banska Bystrica
Query!
Country [245]
0
0
Slovakia
Query!
State/province [245]
0
0
Bardejov
Query!
Country [246]
0
0
Slovakia
Query!
State/province [246]
0
0
Bratislava
Query!
Country [247]
0
0
Slovakia
Query!
State/province [247]
0
0
Humenne
Query!
Country [248]
0
0
Slovakia
Query!
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Malacky
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Nitra
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Presov
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Roznava
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Slovakia
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Zilina
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Badalona
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Spain
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Zaragoza
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Stockholm
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Uppsala
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Basel
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Bern
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St. Gallen
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Switzerland
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Zuerich
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Turkey
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Ankara
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Turkey
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Elazig
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Turkey
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Gaziantep
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Turkey
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Istanbul
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Turkey
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Izmir
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Turkey
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Malatya
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Turkey
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Mersin
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Turkey
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Umuttepe Kocaeli
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Ukraine
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Ukraine
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Kharkiv
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Ukraine
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Kirovohrad
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odessa
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Ukraine
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Poltava
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Ukraine
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Sumy
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Ukraine
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Ternopil
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhia
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Ukraine
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Zaporozhje
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United Kingdom
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Birmingham
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Bristol
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Exeter
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United Kingdom
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Glasgow, Scotland
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United Kingdom
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Glasgow
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Hull
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London
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Manchester
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Nottingham
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Oxford
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United Kingdom
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Shrewsbury
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United Kingdom
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Southhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Celgene
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Ethics approval
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Summary
Brief summary
The purpose of study is to test the effects of an experimental medication GED-0301
(mongersen) in patients who have active Crohn's disease. The study will test GED-0301
compared to placebo for 52 weeks. The study treatment is blinded which means that patients
and the study doctor will not know which treatment has been assigned. Patients in this study
will be allowed treatment with stable doses of oral aminosalicylates, oral corticosteroids,
immunosupressants and antibiotics for the treatment of Crohn's disease.
After 12 weeks in the study until the end of the study, patients who do not have an
improvement in their Crohns disease symptoms will have the option to enter a long term active
treatment study. Participants who discontinued the study anytime or completed the study at
Week 52 were then observed for an additional 4 weeks.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02596893
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Trial related presentations / publications
Gold SL, Cohen-Mekelburg S, Schneider Y, Steinlauf A. Perianal Fistulas in Patients With Crohn's Disease, Part 2: Surgical, Endoscopic, and Future Therapies. Gastroenterol Hepatol (N Y). 2018 Sep;14(9):521-528.
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Public notes
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Contacts
Principal investigator
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Guillermo Rossiter, MD
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Celgene Corporation
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02596893
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