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Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease

NCT01564823 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2015-03-17

No results posted yet for this study

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.

Conditions

  • Crohn´s Disease

Interventions

DRUG

Metronidazole

Metronidazole: 250 mg/8h. 3 months.

DRUG

Metronidazole

Metronidazole 250 mg/8h 3 months

DRUG

Azathioprine

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

DRUG

Adalimumab

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

Sponsors & Collaborators

  • Effice Servicios Para la Investigacion S.L.

    collaborator INDUSTRY

  • Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa

    lead OTHER

Principal Investigators

  • Pilar Nos, MD · Hospital Universitari i Politecnic La Fe (Valencia, Spain)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01564823 on ClinicalTrials.gov