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

Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Sponsors

Lead sponsor: Sara Varea

Collaborator: Hospital Clinic of Barcelona

Source Fundacion Clinic per a la Recerca Biomédica
Brief 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)

Overall Status Terminated
Start Date February 14, 2014
Completion Date June 30, 2018
Primary Completion Date June 30, 2018
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Success of endoscopic dilatation at week 8
Secondary Outcome
Measure Time Frame
Stenosis measure baseline
success of endoscopic dilatation at week 52
Mucosal healing at week 8
Histological cure at week 8
proportion of patients that develop anti-adalimumab antibodies at the end of the study
adverse events at the end of the study
Enrollment 26
Condition
Intervention

Intervention type: Drug

Intervention name: Adalimumab

Description: single intralesional administration during endoscopy process

Arm group label: Adalimumab

Intervention type: Drug

Intervention name: placebo

Description: single intralesional administration during endoscopy

Arm group label: saline

Eligibility

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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility
Complexo Hospitalario Arquitecto Marcide -Novoa Santos | Ferrol, A Coruña, 15405, Spain
Complexo Hospitalario Universitario de Santiago | Santiago de Compostela, A Coruña, 15706, Spain
Hospital Moises Broggi | Sant Joan Despí, Barcelona, 08970, Spain
Hospital Mutua de Terrassa | Terrassa, Barcelona, 08221, Spain
Hospital Universitario Puerta del Hierro | Majadahonda, Madrid, 28222, Spain
Hospital Universitari Son Espases | Palma de Mallorca, Mallorca, 07120, Spain
Hospital General Universitario de Alicante | Alicante, 03010, Spain
Hospital Clinic of Barcelona | Barcelona, 08036, Spain
Hospital del Mar | Barcelona, Spain
Complejo asistencial universitario de Burgos | Burgos, 09005, Spain
Hospital Josep Trueta | Girona, 17007, Spain
Hospital La Paz | Madrid, 28046, Spain
Hospital La Fe | Valencia, 46026, Spain
Location Countries

Spain

Verification Date

December 2018

Responsible Party

Responsible party type: Sponsor-Investigator

Investigator affiliation: Fundacion Clinic per a la Recerca Biomédica

Investigator full name: Sara Varea

Investigator title: Clinical Research Manager

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Adalimumab

Arm group type: Experimental

Description: single administration of Adalimumab 80mg diluted in 5ml saline

Arm group label: saline

Arm group type: Placebo Comparator

Description: 5 ml of saline

Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov