15 results
The aim of this clinical trial is to evaluate the feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.
The purpose of the study is to investigate how quickly and to what extent S 38844 and S 41015 are absorbed, distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Also the involvement of a specific…
Primary: to assess efficacy of weekly subcutaneous (SC) administration of Abatacept vs. placebo on disease activity assessed with ESSDAI at in patients with pSS. Secondary: to assess efficacy of Abatacept on clinical, functional, subjective, and…
- The main hypothesis of this study is that JIA patients at risk of a flare due to subclinical inflammatory activity may be identified by analysis of the phagocyte activity marker S100A12 and hsCRP. The goal is a stratification of the therapeutic…
Primary:to evaluate the safety and tolerability of single dose administration of the study drug in healthy male subjectsto determine the pharmacokinetic parameters following single dose administration of the study drug in healthy male subjectso…
The purpose of the study is to find out if there is a possible influence of Ketoconazole on the effect of RO4602522 (this is called pharmacodynamics). it will be investigated whether and if so to what extent Ketoconazole influences how fast…
The study will be performed in 3 parts, Parts 1, 2 , 3. and 4 (DDI). The purpose of the study is to investigate how safe the compound is and how well the compound is tolerated; this will be investigated in all study parts. In Parts 1 and 2, it will…
Primary:- To assess the effect of multiple doses of ketoconazole on the single-dose pharmacokinetics (PK) of tasquinimod.Secondary:- To assess the safety and tolerability of multiple doses of ketoconazole with single doses of tasquinimod.
Main objective:To assess the relapse rate (defined by clinical and biochemical parameters) over 24 months in patients with acute AAV presenting at first diagnosis of relapse, after 12 months of treatment with abatacept in combination with steroids…
Primary:To determine the effects of multiple-dose ketoconazole (Keto) on the pharmacokinetics of single-dose oral LBH589 in patients with advanced solid tumors.Secondary:In cancer patients with advanced solid tumors:* To assess the pharmacokinetic…
Clinical trial to investigate a difference in effectiveness for the treatment of intertrigo in wich the combination of zinc oxide 10% in ketoconazole will to be compared with zinc oxide 10% and hydrocortisone-acetaat 1% in ketoconazole.
The primary objective for this study is to demonstrate that SC injections of abatacept are non-inferior to IV infusions of abatacept .
To investigate the effect of CTLA4-Ig (abatacept) on phenotype, transcriptional profile, B cell receptor usage and functional parameters of circulating B cells expressing anti-citrullinated protein antibodies (ACPA) in patients with early,…
The sponsor is developing a biological product (DRL_AB) similar to the approved medicine Orencia®. As part of medical-scientific studies to confirm the similarity of the biological products, the Sponsor wants to compare DRL_AB with EU-approved…
The primary aim of this study is to develop ecologically valid listening tests with realistic social consequences of speech understanding difficulties in which physiological outcome measures are applied. Specifically, we aim to develop a speech…