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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001723-12-ES

Enrollment

102

Registered

2013-08-14

Start date

2013-10-07

Completion date

Unknown

Last updated

2018-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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:

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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;Primary end point(s): -Success of endoscopic dilatation at week 8;Timepoint(s) of evaluation of this end point: 8weeks	—

Measure

Time frame

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;Primary end point(s): -Success of endoscopic dilatation at week 8;Timepoint(s) of evaluation of this end point: 8weeks

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Spain

Contacts

Public ContactCTU CLINIC

Clinical Trials Unit - Hospital Clinic of Barcelona

svarea@clinic.ub.es00349322754003343

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026