Clinical trial NCT01564823: Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease
Official title: Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn´s Disease
Keywords: Crohn´s disease
Metronidazole
Azathioprine
Adalimumab
post-chirurgic recurrence
Lead sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2012-03-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: Number of endoscopic recurrences
timeFrame: 52 weeks after the begin of the study
Secondary outcomes:
measure: Number of Crohns´disease remission
timeFrame: 24 weeks
measure: Number of postsurgical recurrences
timeFrame: 52 week
measure: number of hospitalized patients
timeFrame: 52 weeks
measure: Concentration of activity markers
timeFrame: 24 weeks
measure: Number of surgeries
timeFrame: Until 52 week
measure: SIBDQ and EuroQOL indexes
timeFrame: 24 Weeks
measure: Number of Adverse event reports
timeFrame: 52 weeks
measure: Number of Crohns´disease remission
timeFrame: 52 weeks
measure: Concentration of activity markers
timeFrame: 52 weeks
measure: SIBDQ and EuroQOL indexes
timeFrame: 52 weeks
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
state: Barcelona
city: Terrasa
country: Spain
facility: Hospital Mutua de Terrasa
state: Barcelona
city: Puerto Real
country: Spain
facility: Hospital Puerto Real
state: Cádiz
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital General Dr. Negrín
state: Islas Canarias
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
state: La Coruña
city: Fuenlabrada
country: Spain
facility: Hospital de Fuenlabrada
state: Madrid
city: Manises
country: Spain
facility: Hospital de Manises
state: Valencia
city: Barcelona
country: Spain
facility: Hospital de Bellvitge
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital La Paz
city: Madrid
country: Spain
facility: Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Sevilla
country: Spain
facility: Hospital Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital Universitari i Policlinic La Fe
city: Valencia
country: Spain
facility: Hospital Clínico
city: Valladolid
country: Spain
facility: Hospital Río Hortega
Study officials:
affiliation: Hospital Universitari i Politecnic La Fe (Valencia, Spain)
name: Pilar Nos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez-Sanroman A, Vera-Mendoza I, Domenech E, Taxonera C, Vega Ruiz V, Marin-Jimenez I, Guardiola J, Castro L, Esteve M, Iglesias E, Ceballos D, Martinez-Montiel P, Gisbert JP, Minguez M, Echarri A, Calvet X, Barrio J, Hinojosa J, Martin-Arranz MD, Marquez-Mosquera L, Bermejo F, Rimola J, Pons V, Nos P; Spanish GETECCU group [APPRECIA study]. Adalimumab vs Azathioprine in the Prevention of Postoperative Crohn's Disease Recurrence. A GETECCU Randomised Trial. J Crohns Colitis. 2017 Oct 27;11(11):1293-1301. doi: 10.1093/ecco-jcc/jjx051.