7 results
The objectives of the study are as follows:Primary:• Part 1: To assess the pharmacokinetics and relative bioavailability of three different formulations of PA101 (4% cromolyn sodium with and without mannitol, and 6% cromolyn sodium without mannitol…
Primary:* To determine the efficacy profile of PA101 delivered via a high efficiency nebulizer (eFlow®,PARI) in comparison with placebo following 6 weeks of treatment in patients with indolentsystemic mastocytosis (ISM) who are symptomatic despite…
To assess the number of patients in remission, 12 months after dose adjustment of IFX from 5mg/kg to 3 mg/kg. Secondary objectives include: number of relapses, defined by increase of fecal calprotectin and/or CRP and clinical activity, subsequently…
The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule in improving drug exposure (=therapeutic trough levels) without treatment escalation in pediatric CD patients.
- To evaluate the treatment efficiency by time to progression according to RECIST 1.1
To evaluate whether a faecal calprotectin guided strategy of anti-TNF dosing interval lengthening is non-inferior in maintaining remission in patients with IBD compared with an unchanged dosing interval.
The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD. Secondary objectives are determination of the pharmacokinetic/-dynamic profile of IFX and finding predictors of…