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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03220841




Registration number
NCT03220841
Ethics application status
Date submitted
6/07/2017
Date registered
18/07/2017

Titles & IDs
Public title
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Scientific title
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Secondary ID [1] 0 0
StVincentsMelbourneSTRIDENT1
Universal Trial Number (UTN)
Trial acronym
STRIDENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn Disease 0 0
Inflammatory Bowel Diseases 0 0
Stricture; Bowel 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Adalimumab Injection
Treatment: Drugs - Thiopurine
Treatment: Surgery - Endoscopic balloon dilatation

Active comparator: Standard drug therapy - Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)

Experimental: Intensive drug therapy - Adalimumab in combination with dose optimized thiopurine, Intensive induction (160mg weekly for 4 weeks then 40mg fortnightly). Anti-TNF dose may be increased if ongoing inflammation every 4 months until study endpoint.


Treatment: Drugs: Adalimumab Injection
Standard dose adalimumab induction and maintenance

Treatment: Drugs: Thiopurine
Dose optimized thiopurine

Treatment: Surgery: Endoscopic balloon dilatation
Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Improvement in obstructive symptoms.
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Improvement in symptoms
Timepoint [1] 0 0
4, 8 and 12 months
Secondary outcome [2] 0 0
Improvement in biochemical inflammatory parameters
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Improvement in imaging parameters (Intestinal ultrasound)
Timepoint [3] 0 0
12 months
Secondary outcome [4] 0 0
Improvement in imaging parameters
Timepoint [4] 0 0
12 months
Secondary outcome [5] 0 0
Surgery
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Improvement in patient reported outcomes (PROs)
Timepoint [6] 0 0
12 months
Secondary outcome [7] 0 0
Improvement in patient reported outcomes (PROs)
Timepoint [7] 0 0
12 months

Eligibility
Key inclusion criteria
* Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Acute bowel obstruction requiring urgent surgical intervention
* Deemed by treating physician to have high risk of acute bowel obstruction
* Concurrent active perianal sepsis
* Internal fistulising disease in association with strictures (entero-enteric stulas)
* Low rectal or anal strictures
* Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
* Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
* Inability to give informed consent
* Suspected perforation of the gastrointestinal tract
* Pregnancy
* Inability to undergo MRI small bowel due to a contraindication.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2021
Actual
Sample size
Target
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
St. Vincent's Hospital Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3065 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
St Vincent's Hospital Melbourne
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australasian Gastro Intestinal Research Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
AbbVie
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Emily Wright, MBBS PhD
Address 0 0
St Vincent's Hospital Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03220841