25 results
The objective of this study is twofold. First, we want to investigate the effectiveness of a COBRA-plus therapy after incomplete response on COBRA-light therapy after 13 weeks to improve the percentage of RA-patients with a high disease activity and…
Primary Objective: The main objective of this study is to identify a new treatment to alleviate pain and diminish inflammation in patients with hand osteoarthritis with symptoms and signs of inflammation.Secondary Objectives: The secondary…
To validate FDA-approved dosing recommendation for once daily darunavir/ritonavir in children 6-12 years old
Single dose:The objectives of Part 1 (single dose escalation part) are to examine the safety, tolerability and pharmacokinetics (i.e., the circulating levels of TMC558445 in your blood over time) of increasing single oral doses of TMC558445, with…
Primary objective:To assess whether a single day infusion of the GLP-1 RA exenatide, as compared to placebo, reverses GC-induced impairment of glucose metabolism and beta-cell function in healthy males
This is a scientific research with the aim to investigate the bioavailability of a combination of the drugs TMC114 and TMC41629 . The three dosage forms, each only once ingested. In addition, even in this study the safety of the use and possible…
To assess the effects of a 7-day course of 30 mg prednisolone daily in addition to usual care (symptomatic) treatment in adults with RS.
Primary objective* To assess the non-inferiority of darunavir/r + raltegravir compared to darunavir/r + tenofovir/emtricitabine as first-line treatment strategies in HIV-1 infected, antiretroviral naïve adults over at least 96 weeks (i.e. to assess…
The objective of this study is to assess whether sitagliptin may prevent prednisolone-induced impairment of glucose metabolism and beta-cell function.
The purpose of this study is to evaluate the single dose pharmacokinetics and pivotal bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and tenofovir alafenamide (TAF) 10 mg when administered as a fixed dose…
Primary objectives:• To explore whether daily oral treatment with 30 mg prednisolone modulates biomarkers for adverse metabolic effects in a similar manner in patients with chronic atopic dermatitis as compared to healthy volunteers.• To determine…
In this trial we will study if treatment with oral corticosteroids or DMSO is effective in decreasing signs and symptoms of CRPS-1. Tolerance of the treatment options and effects on different subtypes of CRPS-1 patients will be evaluated as well.
This study is designed to demonstrate equal therapeutic effect of Myfortic® as compared to MMF in this patient group, thus improving therapeutic efficacy.
We propose to investigate the effect of administering a broad-acting, potent immune suppressive agent early in the course of the disease as this may prevent neuronal damage caused by low-grade inflammatory processes in the brain. It is expected that…
Primary objective:4To assess the efficacy of AZD9567, 40 mg, compared to prednisolone 20 mg in patients with active rheumatoid arthritis in spite of stable treatment with conventional and/or s.c/i.v. biological Disease-modifying anti-rheumatic drugs…
- To evaluate the single-dose PK and pivotal bioequivalence of 3 compounds darunavir (DRV) 675 mg, FTC 200 mg, and tenofovir alafenamide (TAF) 10 mg in the presence of cobicistat (COBI)150 mg when administered as an fixed-dose combination (FDC) (D/C…
The primary aim of this research is to demonstrate the noninferiority of anakinra compared with the standard of care in the treatment of acute gout flares.Secondary objectives are to compare the cost per quality-adjusted life day between anakinra…
To determine the efficacy of a short high-dose treatment of oral prednisolone for persistent loss of smell after COVID-19 infection in the long term (>12 weeks). ADD: determining the clinical course/natural recovery of loss of smell and taste…
To assess the safety and efficacy of ABBV-154 versus placebo in subjects with PMR, who are dependent on treatment with glucocorticoids withdoses of at least 5 mg/day prednisone equivalent (glucocorticoindependent PMR).
To assess the efficacy and safety of mycophenolate mofetil as induction therapy in patients with treatment naive autoimmune hepatitis.