12 results
Primary Objectives:Part 1:To assess the relative bioavailability and bioequivalence of JZP-258 compared with Xyrem oral solution under fasting and fed conditions.To evaluate the pharmacokinetics (PK) of JZP-258 under fasting and fed conditions (food…
The purpose of the study is to investigate how much JZP-258 is absorbed into the body, how fast JZP-258 is absorbed and eliminated from the body (this is called pharmacokinetics) compared to Xyrem. This comparison is called the relative…
The primary objective of the study is to determine whether baricitinib 4 mg QD is superior toplacebo in the treatment of patients with moderately to severely active RA who have had an inadequate response to a TNF inhibitor, despite ongoing treatment…
The primary objective of the study is to determine whether baricitinib is superior to placebo in the treatment of patients with moderately to severely active rheumatoid arthritis (RA) despite methotrexate treatment (ie, inadequate response to…
* Primary objective: To determine the effect of 78-weeks therapy with omalizumab compared to placebo on the number of sub-epithelial eosinophils, a marker of airway inflammation, in patients with persistent moderate to severe allergic asthma. *…
We aim to investigate whether sodium oxybate can be used as a novel treatment in psychiatric patients with catatonia. Our primary objective is: To determine if sodium oxybate is effective as a novel treatment in psychiatric patients with catatonia…
Primary Objectives: * to establish - which is the best treatment, MTX or baricitinib, to ensure rapid symptom relief of recent onset UA, based on clinical and patient reported outcomes from baseline to 3 months. Secondary Objective: * to establish…
A better understanding on the individual response to different albuminuria lowering drugs and a better understanding why these drugs, of which some are developed for another indication, may help to tailor optimal therapy. Therefore in this study…
To evaluate the effect of baricitinib 4-mg QD and background standard-of-care therapy compared with placebo and background standard-of-care therapy on SLE disease activity.
PrimaryTo evaluate the long-term safety and tolerability of baricitinib in patients with SLE.
The primary objective is to test the hypothesis that baricitinib high dose level in combination with topical corticosteroids (TCS) or baricitinib medium dose level in combination with TCS is superior to placebo in combination with TCS in the…
To evaluate the efficacy of sodium oxybate (SXB) as a medical intervention to treat disrupted night sleep in the ICU.