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Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease (APPRECIA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564823
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : March 17, 2015
Sponsor:
Collaborator:
Effice Servicios Para la Investigacion S.L.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Crohn´s Disease Drug: Metronidazole Drug: Azathioprine Drug: Adalimumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease
Study Start Date : June 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Metronidazole + Azathioprine.
Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study.
Drug: Metronidazole
Metronidazole: 250 mg/8h. 3 months.
Other Name: Flagyl (Metronidazole)

Drug: Azathioprine
Azathioprine: 2.5 mg/kg of weight/day. 3 months.
Other Name: Imurel (Azathioprine)

Active Comparator: 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.
Drug: Metronidazole
Metronidazole 250 mg/8h 3 months
Other Name: Flagyl (Metronidazole)

Drug: Adalimumab
Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.
Other Name: Humira (Adalimumab)




Primary Outcome Measures :
  1. Number of endoscopic recurrences [ Time Frame: 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 :
  1. Number of Crohns´disease remission [ Time Frame: 24 weeks ]
    % of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azathioprin treatment

  2. Number of postsurgical recurrences [ Time Frame: 52 week ]
    Evaluation of the Adalimumab efficiency on preventing postsurgical recurrence with Magnetic Resonance Enterography

  3. number of hospitalized patients [ Time Frame: 52 weeks ]
    Comparing hospitalization percentage in patients using adalimumab or azathioprin after 52 weeks of treatment

  4. Concentration of activity markers [ Time Frame: 24 weeks ]
    Evaluating changes in markers such as reactive c-protein, variable surface glycoprotein , faecal calprotectin, etc.

  5. Number of surgeries [ Time Frame: Until 52 week ]
    Comparing % of patients who needs surgery on Adalimumab vs Azatioprine

  6. SIBDQ and EuroQOL indexes [ Time Frame: 24 Weeks ]
    Quality of life

  7. Number of Adverse event reports [ Time Frame: 52 weeks ]
    Comparison of safety of Adalimumab versus Azatioprine.

  8. Number of Crohns´disease remission [ Time Frame: 52 weeks ]
    % of patients showing clinical remission after 24 and 52 weeks of adalimumab vs azatioprine treatment

  9. Concentration of activity markers [ Time Frame: 52 weeks ]
    Evaluating changes in markers such as reactive c-protein, VSG, faecal calprotectine, etc

  10. SIBDQ and EuroQOL indexes [ Time Frame: 52 weeks ]
    Quality of life



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564823


Locations
Show Show 22 study locations
Sponsors and Collaborators
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Effice Servicios Para la Investigacion S.L.
Investigators
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Principal Investigator: Pilar Nos, MD Hospital Universitari i Politecnic La Fe (Valencia, Spain)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
ClinicalTrials.gov Identifier: NCT01564823    
Other Study ID Numbers: APPRECIA
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: March 17, 2015
Last Verified: March 2015
Keywords provided by Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa:
Crohn´s disease
Metronidazole
Azathioprine
Adalimumab
post-chirurgic recurrence
Additional relevant MeSH terms:
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Crohn Disease
Recurrence
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Disease Attributes
Pathologic Processes
Metronidazole
Adalimumab
Azathioprine
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs