19 results
To evaluate the efficacy of the drug combination. Translational work is aimed to explore pharmacodynamic, predictive and surrogate endpoint biomarkers in tumor tissue and blood.
To evaluate the efficacy of 400 mg QD hydroxychloroquine in hand OA patients after 24 weeks of treatment.
The primary objective of this study is to evaluate the PK of POS administered orally at three dosage levels to immunocompromised children with expected neutropenia (selected oncology patients, aplastic anemia patients and patients which undergo a…
The objectives of this study are:* To determine the percentage of patients with recent-onset RA and UA who achieve and maintain clinical remission on treatment with a combination of methotrexate 25 mg/week and extended prednisone pulse (tapered high…
Primary: To determine the influence of posaconazole on unboosted fosamprenavir pharmacokinetics, and vice versa, in healthy volunteersSecondary: To determine the safety of combined use of fosamprenavir with posaconazole in healthy vol-unteers
Primary: Dose finding for a twice daily regimen for PSZ as prophylactic treatment in children with CGD, based on the exposure to PSZ measured by PSZ trough levels.Secondary:To determine the tolerability of PSZ as prophylactic treatment in children…
To investigate whether tapering MTX first, then the TNFi golimumab (GOL), is more efficacious than tapering GOL first, then MTX, in sustaining remission and reaching drug free remission.
In a clinical trial it will be investigated to what extent combination therapy with LEF and HCQ will 1) inhibit disease activity, in particular improvement of ESSDAI and dryness and 2) inhibit activity of (autoreactive) B-cells, T-cells and pDCs. In…
Primary objective:To determine the effect of obesity (BMI > 35 kg/m2) on the pharmacokinetics of posaconazole and develop a dosing regimen for obese patients. Secondary objective:• To describe the pharmacokinetics of the augmented dose of 400…
To evaluate if treatment with only supportive care or addition of one of two anti-COVID-19 agents (chloroquine or hydroxychloroquine) results in less disease progression in patients with moderate to severe COVID-19 who require hospital admission.
The main purpose of this study is to investigate the effect of nipocalimab on how quickly and to what extent etanercept or hydroxychloroquine is absorbed, distributed, metabolized and eliminated from the body. The study consists of 2 parts, Part 1…
This study is designed to assess the antiviral activity of hydroxychloroquine in patients with SARS-CoV-2 virus. To evaluate the antiviral effects of hydroxychloroquine at the earliest stages of disease, the study will be conducted in outpatient…
We hypothesize that treatment of RA can be individualized by taking into account the presence of autoantibodies and quick response to glucocorticoids and JAK inhibitors. Therefore, the aims of this randomized controlled trial are: 1. To compare…
To deliver proof of concept that antifungal prophylaxis with posaconazole in addition to standard of care (SOC) can reduce the incidence of IAA in ICU patients with severe influenza, in comparison with SOC alone.To assess differences in cytokine…
• To determine the pharmacokinetics of posaconazole (new solid oral and IV) given as prophylaxis to patients who are at risk for developing fungal infections after receiving conditioning therapy (except strictly non myeloablative (NMA)) for…
- In silico definition of the most optimal posaconazole dose for children and adolescents with CF aged 8 to 17 years.- Assess the prevalence of Aspergillus infection in children and adolescents with CF aged 8 -17 years.- An intensive sampling…
To study whether polytherapy (methotrexate plus sulfasalazine plus hydroxychloroquine) results in more patients with inactive disease and therefore less patients who need treatment with a TNF inhibitor after 6 months of treatment compared to primary…
Primary objective:To evaluate the efficacy of each active treatment combination (hydroxychloroquine + leflunomide and hydroxychloroquine + mycophenolate mofetil) based on proportion of responder patients according to preliminary STAR at week 24.…
To assess clinical efficacy and safety of Leflunomide/Hydroxychloroquine in pSS patients in a phase IIb placebo-controlled randomized clinical trial at 24 weeks, followed by a single-arm crossover and an open extension (total duration of 48 weeks)…