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Completed

NCT Number: NCT01564823

Adalimumab on Preventing Post-chirurgic Recurrence on 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metronidazole

Drug

Metronidazole: 250 mg/8h. 3 months.

Other names: Flagyl (Metronidazole)

azathioprine

Drug

Azathioprine: 2.5 mg/kg of weight/day. 3 months.

Other names: Imurel (Azathioprine)

Adalimumab

Drug

Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.

Other names: Humira (Adalimumab)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Other

Collaborators

  • Effice Servicios Para la Investigacion S.L.

Registry information

Official study title

Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease

Acronym: APPRECIA

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 28, 2012
Registry last updated
Mar 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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