38 results
Primary objectives:The primary objectives of this trial are:• To show PK similarity of BI 695500 to MabThera® and Rituxan® and of Rituxan® to MabThera® (three-way PK similarity).• To establish statistical equivalence of efficacy of BI 695500 and…
> Can fatigue in pSS patients be explained by force decline during a fatiguing task, muscle activation, mood, and the serum levels of proinflammatory cytokines? > What is the contribution of central factors (muscle activation) and…
The primary aim of this study is to investigate the recovery of the circadian rhythm of the hypothalamic-pituitary-adrenal axis during a glucocorticoid tapering regime. Secondary objectives include the effect of a tapering regime on melatonin rhythm…
Objective: The primary goal of the current study is to study the immunogenicity and safety of HPV vaccination in patients with an autoimmune disease. Based on retrospective analysis with other vaccines we hypothesize that patients with autoimmune…
The main objective of the study is to investigate whether the strong clinical effects of natalizumab in RRMS can be explained by enhanced functional adaptation mechanisms of the brain and whether enhanced functional reorganisation is sustained over…
The primary objective of this study is to assess the clinical efficacy of SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by more or equal to 5 joints with active arthritis despite MTX therapy…
1. Is KJD clinically non-inferior to current surgical techniques (HTO and TKP)?2. Is KJD superior to HTO in actual structural repair of cartilage?3. Is KJD cost-effective in the long-term compared to HTO and TKP?
Primary: Does immunomodulation brought about by interferon beta-1a (Rebif) enhance or prolong functional reorganization in subjects with RRMS?Secondary: Does interferon beta-1a (Rebif) also affects functional connectivity as measured by resting-…
Primary objectiveTo determine whether a second IVIg dose in GBS patients with a poor prognosis improves functional outcome after 4 weeks.Secondary objectives To investigate whether: - a second IVIg dose in GBS patients with a poor prognosis improves…
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…
The primary objective of this study is to determine the anti-inflammatory potential of mechanical auricular Vagus nerve stimulation in healthy humans.
PrimaryTo assess the prevalence of anti-efalizumab positivity in two sub-populations of psoriatic subjects trated with Raptiva® in the framework of the CLEARESTTM study:- Subjects developing adverse events (AEs) corresponding to pre-specified newly…
The purpose of the study is to investigate to what extent LNP1955 is tolerated and safe.It will also be investigated how quickly and to what extent LNP1955 is absorbed and eliminated from the body (this is called pharmacokinetics). Further, the…
Primary Objective:To evaluate the efficacy potential, safety and tolerability of intravenously administered ANXV, in ascending doses, and two different dosing regimens, in patients with confirmed moderate to severe COVID-19.Secondary Objectives:To…
To demonstrate non-inferiority of a T2T strategy in which conventional synthetic disease modifying drugs (csDMARDs) refractory RApatients are initially treated with tsDMARD baricitinib versus the comparable T2T strategy in which patients are…
The aim of this study is to better understand various prerequisites for the development, implementation, and immunological monitoring of immune regulation restoring therapies in RA patients. To meet this aim, the study is divided into four equally…
This study has been transitioned to CTIS with ID 2024-518966-28-00 check the CTIS register for the current data. The primary goal of this study is to investigate the effects of belimumab on the composition of lymph nodes and the inflamed synovial…
This study has been transitioned to CTIS with ID 2024-511115-25-00 check the CTIS register for the current data. Primary Objective:The primary objective of this study is:• To evaluate the efficacy of namilumab in subjects with chronic pulmonary…
In the coming months, immunocompromised patients treated in our hospital will be requested to undergo vaccination if they comply with the National Institute for Public Health guidelines. For all subgroups, it is of utmost importance to assess the…
To understand walking-related factors that contribute to fatigue and the relationship with total physical activity and social participation in daily life among pwRA and pwOA.