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

Crohn´s Disease Clinical Trial

— APPRECIA  

Official title:

Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01564823
• Other study ID #: APPRECIA
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2012
• Last updated: March 15, 2015
• Start date: June 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn´s Disease
• Recurrence

Intervention

Drug:
• Metronidazole
Metronidazole: 250 mg/8h. 3 months.
• Metronidazole
Metronidazole 250 mg/8h 3 months
• Azathioprine
Azathioprine: 2.5 mg/kg of weight/day. 3 months.
• Adalimumab
Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.

Locations

Country	Name	City	State
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital de Bellvitge	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Arquitecto Marcide	Ferrol	La Coruña
Spain	Hospital de Fuenlabrada	Fuenlabrada	Madrid
Spain	Hospital General Dr. Negrín	Las Palmas de Gran Canaria	Islas Canarias
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 de Manises	Manises	Valencia
Spain	Hospital Puerto Real	Puerto Real	Cádiz
Spain	Hospital Parc Tauli	Sabadell	Barcelona
Spain	Hospital Virgen de la Macarena	Sevilla
Spain	Hospital Mutua de Terrasa	Terrasa	Barcelona
Spain	Hospital Clínico	Valencia
Spain	Hospital Universitari i Policlinic La Fe	Valencia
Spain	Hospital Río Hortega	Valladolid

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa	Effice Servicios Para la Investigacion S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of endoscopic recurrences	Evaluation of the effectiveness on prevention of endoscopic recurrence evaluated as changes in the Rutgeerts Index.	52 weeks after the begin of the study	No
Secondary	Number of Crohns´disease remission	% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azathioprin treatment	24 weeks	No
Secondary	Number of postsurgical recurrences	Evaluation of the Adalimumab efficiency on preventing postsurgical recurrence with Magnetic Resonance Enterography	52 week	No
Secondary	number of hospitalized patients	Comparing hospitalization percentage in patients using adalimumab or azathioprin after 52 weeks of treatment	52 weeks	No
Secondary	Concentration of activity markers	Evaluating changes in markers such as reactive c-protein, variable surface glycoprotein , faecal calprotectin, etc.	24 weeks	No
Secondary	Number of surgeries	Comparing % of patients who needs surgery on Adalimumab vs Azatioprine	Until 52 week	No
Secondary	SIBDQ and EuroQOL indexes	Quality of life	24 Weeks	No
Secondary	Number of Adverse event reports	Comparison of safety of Adalimumab versus Azatioprine.	52 weeks	Yes
Secondary	Number of Crohns´disease remission	% of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azatioprine treatment	52 weeks	No
Secondary	Concentration of activity markers	Evaluating changes in markers such as reactive c-protein, VSG, faecal calprotectine, etc	52 weeks	No
Secondary	SIBDQ and EuroQOL indexes	Quality of life	52 weeks	No