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

Conditions

• Crohn´s Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Metronidazole — DRUG
  Metronidazole: 250 mg/8h. 3 months.
• Metronidazole — DRUG
  Metronidazole 250 mg/8h 3 months
• Azathioprine — DRUG
  Azathioprine: 2.5 mg/kg of weight/day. 3 months.
• Adalimumab — DRUG
  Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.

Study Details

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.

Key Dates

Start date

Jun 30, 2012

Status verified

Mar 2015

Primary completion

Jan 31, 2015

Completion

Jan 31, 2015

Study Design

Enrollment

86 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Metronidazole + Azathioprine.
  Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study.
• 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.

Primary Outcome Measure

Number of endoscopic recurrences [ Time Frame: 52 weeks after the begin of the study ]