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Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease

Information source: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn´s Disease

Intervention: Metronidazole (Drug); Metronidazole (Drug); Azathioprine (Drug); Adalimumab (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Official(s) and/or principal investigator(s):
Pilar Nos, MD, Principal Investigator, Affiliation: Hospital Universitari i Politecnic La Fe (Valencia, Spain)

Summary

The present study objective is evaluate Adalimumab efficacy versus Azathioprine efficacy on prevention of endoscopic recurrence (Rutgeerts Index= 2b, 3 or 4) in Crohns Disease patients after 52 weeks of treatment.

Clinical Details

Official title: Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: Number of endoscopic recurrences

Secondary outcome:

Number of Crohns´disease remission

Number of postsurgical recurrences

number of hospitalized patients

Concentration of activity markers

Number of surgeries

SIBDQ and EuroQOL indexes

Number of Adverse event reports

Number of Crohns´disease remission

Concentration of activity markers

SIBDQ and EuroQOL indexes

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age ≥ 18 years of age at the time of signing informed consent.

- Patients with Crohn's disease who have undergone an ileocecal/ileocolic resection (L1

or L3). The study and the treatment must be initiated within the two first weeks after the resection (+/- 5 days).

- Patients with surgical reconstruction by ileocolic anastomosis.

- Women of childbearing age must not be breastfeeding and must have a negative urine

pregnancy test and must agree to use contraceptive methods with a <1% failure rate (e. g., sexual abstinence, oral contraceptives, double barrier methods, intrauterine devices), unless they only have one partner who is sterile.

- Patients who have signed and dated the informed consent form before performing any

specific screening study procedure. Exclusion Criteria:

- Resection that requieres Temporal ileostomy.

- Urgency resection which doesn´t permit the initial assessment protocol completion.

- Resection due to inactive short indolent stenosis (<10 cm).

- Resection with mucosal macroscopic residual disease in anastomosis.

- Previous intolerance or adverse reaction (moderate or severe) to adalimumab or

azathioprine.

- Any contraindications or unwillingness to perform the scheduled colonoscopies or

resonances.

- Contraindications to Adalimumab treatment, among which the following are included:

active tuberculosis, severe infections such as sepsis or opportunistic infections, moderate or severe heart failure (NYHA class III or IV), central nervous system demyelinating diseases, history of malignant neoplasm or autoimmune diseases.

- Severe associated Extraintestinal manifestations.

- Previous postoperative recurrence prevention treatments with adalimumab, asathiprine

o mercaptopurine which resulted in failure.

- Any other disease or patient condition that according to investigator criteria,

inadequates patient´s participation in the study.

Locations and Contacts

Hospital de Bellvitge, Barcelona, Spain

Hospital del Mar, Barcelona, Spain

Hospital Reina Sofía, Córdoba, Spain

Hospital Clínico San Carlos, Madrid, Spain

Hospital Doce de Octubre, Madrid, Spain

Hospital Gregorio Marañón, Madrid, Spain

Hospital La Paz, Madrid, Spain

Hospital La Princesa, Madrid, Spain

Hospital Puerta de Hierro, Madrid, Spain

Hospital Ramón y Cajal, Madrid, Spain

Hospital Virgen de la Macarena, Sevilla, Spain

Hospital Clínico, Valencia, Spain

Hospital Universitari i Policlinic La Fe, Valencia 46026, Spain

Hospital Río Hortega, Valladolid, Spain

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Hospital Parc Tauli, Sabadell, Barcelona, Spain

Hospital Mutua de Terrasa, Terrasa, Barcelona, Spain

Hospital Puerto Real, Puerto Real, Cádiz, Spain

Hospital General Dr. Negrín, Las Palmas de Gran Canaria, Islas Canarias, Spain

Hospital Arquitecto Marcide, Ferrol, La Coruña, Spain

Hospital de Fuenlabrada, Fuenlabrada, Madrid, Spain

Hospital de Manises, Manises, Valencia, Spain

Additional Information

Starting date: June 2012
Last updated: March 15, 2015

Page last updated: August 23, 2015

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