Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Sponsor
St Vincent's Hospital Melbourne
Study ID
NCT03220841
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab Injection — DRUG
    Standard dose adalimumab induction and maintenance
  • Thiopurine — DRUG
    Dose optimized thiopurine
  • Endoscopic balloon dilatation — PROCEDURE
    Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.

Study Details

Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.

Key Dates

Start date
Oct 9, 2017
Status verified
Oct 2020
Primary completion
Sep 18, 2020
Completion
Sep 30, 2021

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Improvement in obstructive symptoms. [ Time Frame: 12 months ]

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