adalimumab intralesional in intestinal strictures of Crohn's disease patients

• Register: EUCTR
• Last refreshed on: 4 December 2018
• Main ID: EUCTR2012-001723-12-ES
• Date of registration: 14/08/2013
• Prospective Registration: Yes
• Primary sponsor: Fundació Clínic per a la Recerca Biomèdica
• Public title: adalimumab intralesional in intestinal strictures of Crohn's disease patients
• Scientific title: A randomized, double-blinded, placebo-controlled study on the effects of adalimumab intralesional intestinal strictures of Crohn's disease patients
• Date of first enrolment: 07/10/2013
• Target sample size: 102
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001723-12
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: CTU CLINIC
• Affiliation: Clinical Trials Unit - Hospital Clinic of Barcelona

• Name: CTU CLINIC
• Affiliation: Clinical Trials Unit - Hospital Clinic of Barcelona

Key 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion criteria:
-Patients with large intestinal stenosis (more than 6cm) and multiples
-Patients with previous or actual treatment with anti-TNF drugs
-Patients with positive serology to HBV,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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Crohn disease
MedDRA version: 16.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders

Intervention(s)

Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intralesional use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 8weeks

Primary end point(s): -Success of endoscopic dilatation at week 8

Main Objective: Determine that intralesional administration of Adalimumab associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo

Secondary Objective: -To demonstrate that the intralesional injection of Adalimumab associated with endoscopic dilatation will decrease the necessity of endoscopic redilatation or surgery at week 52
-To evaluate the mucosal cure rate associated with the stenosis resolution at week 8 and week 52 after endoscopic dilatation, defined, in case of postsurgical stenosis, as Rutgeert´s index equal or less than 2
-To evaluate the complication incidence associated with every one of realized procedures as well as the adverse events in every group of treatment
-To analyze the rate of formation of anti-adalimumab antibodies during the follow up after unique local injection of the drug
-To determinate the histological cure rate at week 8 after the injection of the drug or placebo

Secondary Outcome(s)

Secondary end point(s): -The estimation of stenosis measure , the endoscopic pre and post-dilatation stenosis diameter will be estimated
-The success of endoscopic dilatation at week 52(absence of clinical subocclusion, no necessity of surgical nor endoscopic dilatation)
-Mucosal cure at week 8
-Histological cure at week 8
-Proportion of patients the develop anti-adalimumab antibodies

Timepoint(s) of evaluation of this end point: 8 and 52 weeks

Secondary ID(s)

CSAI

Source(s) of Monetary Support

del Ministerio de Economía y Competitividad