Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Study Purpose

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)

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Study Type
Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT01986127

Phase 0: Exploratory study involving very limited human exposure to the drug to determine whether a drug is modulating its target.

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Sara Varea

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherOther
Overall Status Recruiting
Countries Spain

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Crohn's Disease

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Ferrol, A Coruña, Spain

Status

Recruiting

Address

Complexo Hospitalario Arquitecto Marcide -Novoa Santos

Ferrol, A Coruña, 15405

Site Contact

Ana Echarri, MD

ana.echarri.piudo@sergas.es

Santiago de Compostela, A Coruña, Spain

Status

Active, not recruiting

Address

Complexo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruña, 15706

Hospital Parc Taulí, Sabadell, Barcelona, Spain

Status

Not yet recruiting

Address

Hospital Parc Taulí

Sabadell, Barcelona, 08208

Site Contact

Enric Brullet, MD

ebrullet@tauli.cat

Hospital Moises Broggi, Sant Joan Despí, Barcelona, Spain

Status

Active, not recruiting

Address

Hospital Moises Broggi

Sant Joan Despí, Barcelona, 08970

Hospital Mutua de Terrassa, Terrassa, Barcelona, Spain

Status

Active, not recruiting

Address

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221

Hospital Universitario Puerta del Hierro, Majadahonda, Madrid, Spain

Status

Active, not recruiting

Address

Hospital Universitario Puerta del Hierro

Majadahonda, Madrid, 28222

Hospital Universitari Son Espases, Palma de Mallorca, Mallorca, Spain

Status

Active, not recruiting

Address

Hospital Universitari Son Espases

Palma de Mallorca, Mallorca, 07120

Alicante, Spain

Status

Active, not recruiting

Address

Hospital General Universitario de Alicante

Alicante, , 03010

Hospital Clinic of Barcelona, Barcelona, Spain

Status

Recruiting

Address

Hospital Clinic of Barcelona

Barcelona, , 08036

Site Contact

Begoña Gonzalez Suarez, MD

BGONZALS@clinic.ub.es

Hospital del Mar, Barcelona, Spain

Status

Active, not recruiting

Address

Hospital del Mar

Barcelona, ,

Burgos, Spain

Status

Active, not recruiting

Address

Complejo asistencial universitario de Burgos

Burgos, , 09005

Hospital Josep Trueta, Girona, Spain

Status

Active, not recruiting

Address

Hospital Josep Trueta

Girona, , 17007

Hospital La Paz, Madrid, Spain

Status

Active, not recruiting

Address

Hospital La Paz

Madrid, , 28046

Hospital La Fe, Valencia, Spain

Status

Active, not recruiting

Address

Hospital La Fe

Valencia, , 46026

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