669 results
The primary objective is to evaluate the efficacy of i) a prime-and-boost regimen with 20 µg Diamyd and ii) a prime-and-boost regimen with 20 µg Diamyd, followed by 2 additional single doses with 20 µg Diamyd, compared to placebo with respect…
Primary:The primary objective of this study is to assess, relative to placebo, the efficacy, tolerability, andsafety of teplizumab when administered according to 3 different teplizumab dosing regimens insubjects with recent-onset (onset within past…
Validation of the DBS sampling method of cyclosporin in TDM practice
The present study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of ARA 290 administered intravenously to healthy subjects, and of intravenously and subcutaneously administered ARA 290 to renally impaired subjects.
To determine if AN-PEP is capable of detoxifying gluten in vivo in patients diagnosed with coeliac disease
Primary: To assess the antiviral efficacy of triple combination antiviral drug (TCAD) therapy(i.e. amantadine and ribavirin co-administered with oseltamivir) compared to oseltamivirmonotherapy in immunocompromised subjects diagnosed with Influenza…
To investigate the safety, tolerability and behavior in the body (absorption and excretion) of oral intake of TMC589337 and TMC589354 after ascending single intakes. In addition, the safety, tolerability and behavior in the body after multipe dose…
The main objective of this study is to determine the role of TSH in the generation of new T cells by thymopoiesis
Primary Objective* To assess the safety, tolerability, and efficacy (in terms of change in DAS28 [using C-ReactiveProtein (CRP)] from baseline) of JNJ-38518168 at a dose of 100 mg/day for up to 12 weekscompared to placebo in subjects with active…
To evaluate the safety, tolerability and pharmacokinetics of ascending single and multiple doses of CH-4051.
We here propose a pilot immuno-PET study in active relapsing MS patients to investigate safety and sensitivity of 89Zr-rituximab in detecting CD20 positive (active) MS lesions and to assess inter-patient variability in 89Zr-rituximab biodistribition…
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…
To evaluate the efficacy of ACZ885 plus MTX by assessing the response to treatment (ACR50) as compared to MTX alone in early RA patients after 6, 14 and 26 weeks of treatment. The study aims to evaluate the clinical response in this RA subpopulation…
To assess, in patients with systemic lupus erythematosus, the effect on disease activity of a regimen with myfortic® versus continuation of azathioprine.
Primary: To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy (see Definitions).Subjects will be…
The objective of the study is to see whether oral administration of probiotics can modulate certain immunological markers which are associated with accelarated atherosclerosis in patients with ANCA associated vasculitis.
The purpose of this 5-year trial is to determine if the surgical procedure, extended transsternal thymectomy (ETTX), combined with prednisone therapy is more beneficial in treating individuals with non-thymomatous MG than prednisone therapy alone.
To show that treatment with SUBLIVAC® Grasses is clinically effective by means of reduction in allergic symptoms and/or use of allergic symptomatic medication in subjects suffering from IgE mediated allergic complaints triggered by grass pollen.
To investigate the efficacy (and the toxicity) of Glivec in systemic sclerosis by examining clinical outcomes (clinical and laboratory findings).
The primary objective of this study will be overall response to treatment with Estetrol in patients with primary Sjogren*s syndrome.