Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease
NCT ID: NCT01564823
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
86 participants
INTERVENTIONAL
2012-06-30
2015-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Interest of the Dosage of Adalimumab Serum Levels in Crohn's Disease Patients for Prevention of Postoperative Recurrence
NCT04200547
Study of Adalimumab Treatment for Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
NCT00409617
Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants
NCT01562951
Azathioprine in the Prevention of Ileal Crohn's Disease Postoperative Recurrence.
NCT02247258
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
NCT00195715
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Metronidazole + Azathioprine.
Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study.
Metronidazole
Metronidazole: 250 mg/8h. 3 months.
Azathioprine
Azathioprine: 2.5 mg/kg of weight/day. 3 months.
Metronidazole + 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
Metronidazole 250 mg/8h 3 months
Adalimumab
Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Effice Servicios Para la Investigacion S.L.
INDUSTRY
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pilar Nos, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitari i Politecnic La Fe (Valencia, Spain)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital de Bellvitge
Barcelona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital Parc Tauli
Sabadell, Barcelona, Spain
Hospital Mutua de Terrasa
Terrassa, Barcelona, Spain
Hospital General Dr. Negrín
Las Palmas de Gran Canaria, Canary Islands, Spain
Hospital Puerto Real
Puerto Real, Cádiz, Spain
Hospital Reina Sofía
Córdoba, Córdoba, Spain
Hospital Arquitecto Marcide
Ferrol, La Coruña, Spain
Hospital de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Doce de Octubre
Madrid, Madrid, Spain
Hospital Gregorio Marañón
Madrid, Madrid, Spain
Hospital La Paz
Madrid, Madrid, Spain
Hospital La Princesa
Madrid, Madrid, Spain
Hospital Puerta de Hierro
Madrid, Madrid, Spain
Hospital Ramón y Cajal
Madrid, Madrid, Spain
Hospital Virgen de la Macarena
Seville, Sevilla, Spain
Hospital de Manises
Manises, Valencia, Spain
Hospital Universitari i Policlinic La Fe
Valencia, Valencia, Spain
Hospital Clínico
Valencia, Valencia, Spain
Hospital Río Hortega
Valladolid, Valladolid, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APPRECIA
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.