Trials / Completed
CompletedNCT01564823
Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease
Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 86 (actual)
- Sponsor
- Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-06-01
- Primary completion
- 2015-01-01
- Completion
- 2015-01-01
- First posted
- 2012-03-28
- Last updated
- 2015-03-17
Locations
22 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT01564823. Inclusion in this directory is not an endorsement.