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

Phase 3

Completed

• Conditions: Crohn´s Disease
• Interventions: Drug: Metronidazole; Drug: Adalimumab; Drug: Azathioprine

• Registration Number: NCT01564823
• Lead Sponsor: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-03-26
• Study First Posted: 2012-03-28
• Study Start: 2012-06
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-15
• Last Update Posted: 2015-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metronidazole + Adalimumab	Adalimumab	Metronidazole Oral Intake. 250 mg/8h. During 3 months. Adalimumab Subcutaneous 160 mg and 80 mg 2wk. Then 40 mg during 2wk as maintenance.
Metronidazole + Adalimumab	Metronidazole	Metronidazole Oral Intake. 250 mg/8h. During 3 months. Adalimumab Subcutaneous 160 mg and 80 mg 2wk. Then 40 mg during 2wk as maintenance.
Metronidazole + Azathioprine.	Azathioprine	Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study.
Metronidazole + Azathioprine.	Metronidazole	Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study.

Primary Outcome Measures

Name	Time	Method
Number of endoscopic recurrences	52 weeks after the begin of the study	Evaluation of the effectiveness on prevention of endoscopic recurrence evaluated as changes in the Rutgeerts Index.

Secondary Outcome Measures

Name	Time	Method
Number of postsurgical recurrences	52 week	Evaluation of the Adalimumab efficiency on preventing postsurgical recurrence with Magnetic Resonance Enterography
Number of Crohns´disease remission	52 weeks	% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azatioprine treatment
SIBDQ and EuroQOL indexes	52 weeks	Quality of life
number of hospitalized patients	52 weeks	Comparing hospitalization percentage in patients using adalimumab or azathioprin after 52 weeks of treatment
Concentration of activity markers	52 weeks	Evaluating changes in markers such as reactive c-protein, VSG, faecal calprotectine, etc
Number of surgeries	Until 52 week	Comparing % of patients who needs surgery on Adalimumab vs Azatioprine
Number of Adverse event reports	52 weeks	Comparison of safety of Adalimumab versus Azatioprine.

Trial Locations

Locations (22)

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

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Arquitecto Marcide; 🇪🇸 Ferrol, La Coruña, Spain

Hospital de Fuenlabrada; 🇪🇸 Fuenlabrada, Madrid, Spain

Hospital de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, 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 Universitari i Policlinic La Fe; 🇪🇸 Valencia, Spain

Hospital Clínico; 🇪🇸 Valencia, 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 de Manises; 🇪🇸 Manises, Valencia, Spain