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Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients | Clinical Trials | Clareo Health

TERMINATEDPHASE3

Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

A Randomized, Double-blinded, Placebo-controlled Study on the Effects of Adalimumab Intralesional Intestinal Strictures of Crohn's Disease Patients

NCT01986127•Sara Varea

View on ClinicalTrials.gov

Summary

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)

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (13)

Complexo Hospitalario Arquitecto Marcide -Novoa Santos

Ferrol, A Coruña, Spain

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, Spain

Hospital Moises Broggi

Sant Joan Despí, Barcelona, Spain

Hospital Mutua de Terrassa

Terrassa, Barcelona, Spain

Hospital Universitario Puerta del Hierro

Majadahonda, Madrid, Spain

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, Spain

Hospital General Universitario de Alicante

Alicante, Spain

Hospital Clinic of Barcelona

Barcelona, Spain

Hospital del Mar

Barcelona, Spain

Complejo asistencial universitario de Burgos

Burgos, Spain

Key Dates

Start Date

February 14, 2014

Primary Completion Date

June 30, 2018

Completion Date

June 30, 2018

Last Updated

December 13, 2018

Enrollment

ACTUAL participants

Conditions

Crohn's Disease

Interventions

Adalimumab

DRUG

placebo

DRUG

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

NCT06226883

Inflammatory Bowel DiseasesCrohn's Disease

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RECRUITINGPHASE3

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

NCT07184931

Crohn's Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study to Evaluate MORF-057 in Adults With Moderately to Severely Active Crohn's Disease

An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease

DB-3Q bmMSC-EVs in Patients With Perianal Fistulizing Crohn's Disease

Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD

A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease

Safety of Allogeneic Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) to Treat Perianal Fistulas w/ Crohn's Disease