Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Sara Varea

Status and phase

Terminated

Phase 3

Conditions

Crohn's Disease

Treatments

Drug: Adalimumab

Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01986127

CSAI

2012-001723-12 (EudraCT Number)

Details and patient eligibility

About

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)

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients of both sexes older than 18 years
Patient diagnosed of CROHN´s disease
Patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum)
Stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy)
Dilated stenosis according to endoscopist criteria (pass or no the endoscopy)
Patient capable of participate in the examinations required by the study
Patient after being informed, give his/her informed consent in writing

Exclusion criteria

Patients with large intestinal stenosis (more than 6cm) and multiples
Patients with previous or actual treatment with anti-tumor necrosis factor (anti-TNF) drugs
Patients with positive serology to hepatitis B virus(HBV),hepatitis C virus (HCV), or HIV
Patients with positive screening to Tuberculosis(positive PPD)
Established contraindication to anti-TNF drugs
Existence of fistulous tracts associated with intestinal stenosis
Neoplastic process associated with stenosis or in another location
Pregnancy or breastfeeding