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Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Primary Purpose

Crohn's Disease

Status

Terminated

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Adalimumab

placebo

About this trial

This is an interventional treatment trial for Crohn's Disease focused on measuring Crohn disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Adalimumab

saline

Arm Description

single administration of Adalimumab 80mg diluted in 5ml saline

5 ml of saline

Outcomes

Primary Outcome Measures

Success of endoscopic dilatation

Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis

Secondary Outcome Measures

Stenosis measure

The endoscopic stenosis diameter will be estimated pre and post-dilatation

success of endoscopic dilatation

The success of endoscopic dilatation at week 52 means absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation

Mucosal healing

Anastomotic strictures: We define mucosal healing as a Rutgeerts < or equal 2 with at least 1 point of improvement (añadir el score) Primary strictures: Absence of ulcers after treatment

Histological cure

We consider histological cure if: Epithelial damage is < or equal 1 Architectural changes is < or equal 1 Infiltration of mononuclear cells in lamina propria is < or equal 1 Polymorphonuclear cells in the lamina propria = 0 Polymorphonuclear cells in epithelium = 0 Absence of erosions and ulcers (based ib scoring system for Histologic Abnormalities in Crohn's disease Mucosal Biopsy Specimens - Title: Early lesions of recurrent Crohn's disease caused by infusion of intestinal contents in excluded ileum Author(s): D'Haens, Geert R.; Geboes, Karel; Peeters, Mark; et al. Source: Gastroenterology Volume: 114 Issue: 2 Pages: 262-267 Published: Feb., 1998)

proportion of patients that develop anti-adalimumab antibodies

adverse events

Full Information

NCT ID

NCT01986127

First Posted

October 9, 2013

Last Updated

December 11, 2018

Sponsor

Sara Varea

Collaborators

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT01986127

Brief Title

Adalimumab Intralesional in Intestinal Strictures of Crohn's Disease Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Terminated

Why Stopped

slow recruitment

Study Start Date

February 14, 2014 (undefined)

Primary Completion Date

June 30, 2018 (Actual)

Study Completion Date

June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sara Varea

Collaborators

Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab

Arm Type

Experimental

Arm Description

single administration of Adalimumab 80mg diluted in 5ml saline

Arm Title

saline

Arm Type

Placebo Comparator

Arm Description

5 ml of saline

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Intervention Description

single intralesional administration during endoscopy process

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

single intralesional administration during endoscopy

Primary Outcome Measure Information:

Title

Success of endoscopic dilatation

Description

Successful dilatation means the passage of the endoscope (or enteroscopy colonoscope) through the stenosis

Time Frame

at week 8

Secondary Outcome Measure Information:

Title

Stenosis measure

Description

The endoscopic stenosis diameter will be estimated pre and post-dilatation

Time Frame

baseline

Title

success of endoscopic dilatation

Description

The success of endoscopic dilatation at week 52 means absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation

Time Frame

at week 52

Title

Mucosal healing

Description

Anastomotic strictures: We define mucosal healing as a Rutgeerts < or equal 2 with at least 1 point of improvement (añadir el score) Primary strictures: Absence of ulcers after treatment

Time Frame

at week 8

Title

Histological cure

Description

Time Frame

at week 8

Title

proportion of patients that develop anti-adalimumab antibodies

Time Frame

at the end of the study

Title

adverse events

Time Frame

at the end of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials: