EUCTR2011-002061-38-BEActive, not recruitingPhase 1
A randomised prospective trough level monitoring study with real-time therapeutic adaptations: Trough level Adapted infliXImab Treatment scheme (TAXIT). - TAXIT
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Males and females = 18 and = 64 years of age
- •- Diagnosis of CD or UC confirmed by endoscopy and histology and in stable clinical remission
- •- Signed informed consent
- •- On anti-TNF infliximab maintenance therapy for at least 14 consecutive weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •- Not willing to participate in study or not willing to sign inform consent
- •- Patients included in placebo-controlled trials
- •- Patients not in stable remission upon entry into the study (designated by symptoms, CRP>5mg/ml and endoscopic lesions)
Investigators
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