Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants

Sponsor
Grupo Espanol de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa
Study ID
NCT01562951
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ADALIMUMAB — DRUG
    Adalimumab at 160/80 mg and maintained on 40 mg eow until next colonoscopy performed at week 48. If before week 48, an increase of more than 50% is observed in calprotectin and/or hsCRP from baseline, over two consecutive follow up visits 2 weeks apart, the colonoscopy will be performed earlier. If patients have still significant endoscopic lesions, adalimumab or adalimumab placebo will be intensified to 40 mg weekly.
  • Placebo — DRUG
    PLACEBO at 160/80 mg and maintained on 40 mg eow until next colonoscopy performed at week 48. If before week 48, an increase of more than 50% is observed in calprotectin and/or hsCRP from baseline, over two consecutive follow up visits 2 weeks apart, the colonoscopy will be performed earlier. If patients have still significant endoscopic lesions, adalimumab or adalimumab placebo will be intensified to 40 mg weekly

Study Details

This study will test that individualized treatment in patients with Crohn's Disease in remission or mild clinical activity under immunosuppressants may improve prognosis, rather than just treating flares.

Key Dates

Start date
Oct 31, 2012
Status verified
May 2016
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: PLACEBO
    Treatment with placebo
  • Active Comparator: ADALIMUMAB
    Treatment with Adalimumab

Primary Outcome Measure

The primary efficacy endpoint is the rate of therapeutic failure up to week 48 [ Time Frame: Every 12 weeks up to Week 48 ]

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