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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Sofía
      • Madrid, Spain
        • Hospital Ramon 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 Clínico
      • Valencia, Spain, 46026
        • Hospital Universitari i Policlinic La Fe
      • Valladolid, Spain
        • Hospital Rio Hortega
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Germans Trías 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Effice Servicios Para la Investigacion S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 26, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 17, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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