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 Crohn´s 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 remissionNumber 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 SofÃa, Córdoba, Spain
Hospital ClÃnico 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 ClÃnico, Valencia, Spain
Hospital Universitari i Policlinic La Fe, Valencia 46026, Spain
Hospital RÃo 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. NegrÃn, 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
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