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

March 15, 2015 updated by: Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

86

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital de Bellvitge
      • Córdoba, Spain
        • Hospital Reina Sofia
      • Madrid, Spain
        • Hospital Ramón y Cajal
      • Madrid, Spain
        • Hospital Gregorio Marañón
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Hospital La Princesa
      • Madrid, Spain
        • Hospital Puerta de Hierro
      • Sevilla, Spain
        • Hospital Virgen de la Macarena
      • Valencia, Spain
        • Hospital Clinico
      • Valencia, Spain, 46026
        • Hospital Universitari i Policlinic La Fe
      • Valladolid, Spain
        • Hospital Rio Hortega
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Germans Trias i Pujol
      • Sabadell, Barcelona, Spain
        • Hospital Parc Tauli
      • Terrasa, Barcelona, Spain
        • Hospital Mutua de Terrasa
    • Cádiz
      • Puerto Real, Cádiz, Spain
        • Hospital Puerto Real
    • Islas Canarias
      • Las Palmas de Gran Canaria, Islas Canarias, Spain
        • Hospital General Dr. Negrín
    • La Coruña
      • Ferrol, La Coruña, Spain
        • Hospital Arquitecto Marcide
    • Madrid
      • Fuenlabrada, Madrid, Spain
        • Hospital De Fuenlabrada
    • Valencia
      • Manises, Valencia, Spain
        • Hospital de Manises

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • Flagyl (Metronidazole)
Drug: Metronidazole
Metronidazole 250 mg/8h 3 months
Other Names:
  • Flagyl (Metronidazole)
Drug: Azathioprine
Azathioprine: 2.5 mg/kg of weight/day. 3 months.
Other Names:
  • 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 Names:
  • Flagyl (Metronidazole)
Drug: Metronidazole
Metronidazole 250 mg/8h 3 months
Other Names:
  • Flagyl (Metronidazole)
Drug: Adalimumab
Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.
Other Names:
  • Humira (Adalimumab)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
52 weeks after the begin of the study

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Collaborators

Effice Servicios Para la Investigacion S.L.

Investigators

  • Principal Investigator: Pilar Nos, MD, Hospital Universitari i Politecnic La Fe (Valencia, Spain)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

March 17, 2015

Last Update Submitted That Met QC Criteria

March 15, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APPRECIA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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