Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Sponsor
Sara Varea
Study ID
NCT01986127
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — DRUG
    single intralesional administration during endoscopy process
  • placebo — DRUG
    single intralesional administration during endoscopy

Study Details

We study if the administration of intralesional Adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with Crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)

Key Dates

Start date
Feb 14, 2014
Status verified
Dec 2018
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018

Study Design

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

Arms

  • Experimental: Adalimumab
    single administration of Adalimumab 80mg diluted in 5ml saline
  • Placebo Comparator: saline
    5 ml of saline

Primary Outcome Measure

Success of endoscopic dilatation [ Time Frame: at week 8 ]

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