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A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis

The primary objective of this study is to assess whether the efficacy of ocrelizumab given as two dose regimens of 600 mg (given as 300 mg infusions on days 1 and 15 and 600 mg infusion in the following cycles) or 400 mg (given as 200 mg infusions…

Efficacy, pharmacokinetics, and safety of BI 695500 versus rituximab in patients with moderately to severely active rheumatoid arthritis: a randomized, double-blind, parallel arm, multiple dose, active comparator trial.

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…

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Assess the Long-Term Efficacy and Safety of Prolonged Release Fampridine (BIIB041) 10 mg, Administered Twice Daily in Subjects with Multiple Sclerosis (ENHANCE)

Primary:The primary objective of Study 218MS305 is to determine whether prolonged-release fampridine (10 mg BID) has a clinically meaningful effect on patient-reported walking ability over a 24-week study period.Secondary:The secondary objectives…

Pharmacokinetics and safety of Meropenem in infants below 90 days of age (inclusive) with probable and confirmed meningitis: a European multicenter phase I- II trial

Primairy objectivesTo study the pharmacokinetics (plasma and cerebrospinal fluid) of meropenem in infants <= 90 days of postnatal age with probable or confirmed bacterial meningitis (BM); To describe the safety profile of meropenem in the…

Can bilateral functional electrical stimulation (FES) of the calf muscles improve ankle push-off during gait in people with Multiple Sclerosis? A proof of principle study

Aim of this proof of principle study is to develop a reliable and safe application of bilateral FES of the calf muscles to facilitate insufficient push-off in patients with MS and to assess the preliminary effects of FES on net ankle power…

A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 SC (subcutaneous) injection once a week or every other week is safe and effective compared to placebo (an inactive solution injection ) in reducing the recurrence and symptoms of Ankylosing…

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Exploratory Study to Assess the Effect of Treatment With Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Walking Ability and Balance in Subjects with Multiple Sclerosis (MOBILE)

The objectives of this study in MS subjects treated with prolonged-release fampridine 10 mg twice daily compared with subjects treated with placebo are: - To assess the effect of prolonged-release fampridine over 24 weeks on the following parameters…

Prednisolone addition for patients with recent onset psychotic disorder: the role of immune-modulating strategies in the treatment of psychosis.

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…

A 3-year, multi-center study to evaluate optical coherencetomography as an outcome measure in patients with multiple sclerosis

Primary objective: To evaluate change in RNFL thickness in RRMS patients followed for up to 36 monthscompared to a group of reference subjects (without neurologic or ophthalmic disease) todetermine whether the technology is sufficiently sensitive to…

EMR 200136-532: A three-arm, randomized, double-blind, placebo controlled, multicenter, phase II study to evaluate the efficacy of Vigantol® oil as add-on therapy in subjects with Relapsing-Remitting Multiple Sclerosis receiving treatment with Rebif®

Primary objective: To assess the efficacy of Vigantol oil versus placebo as add-on therapy in subjects with relapsing-RemittingMultiple sclerosis receiving treatment with Rebif.Secondary objective:To assess changes on clinical parametersto assess…

A four-arm randomised, double-blind, placebo-controlled, multicentre Phase II study to evaluate the safety, tolerability and efficacy as assessed by frequent MRI measures of three doses of atacicept monotherapy in subjects with relapsing multiple sclerosis (RMS) over a 36 weeks treatment course.

Primary Objective: • The primary objective of the study is to evaluate the efficacy of three doses of atacicept to reduce CNS inflammation in subjects with RMS as assessed by frequent MRI.Secondary Objectives: • Evaluate safety and tolerability of…

A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS)

The purpose of this study is to determine if SAR153191 150 mg once a week (qw) SC (subcutaneous) administration is safe and effective in reducing the recurrence and symptoms of ankylosing spondylitis over a long period of time (up to 5 years).

A phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of Rebif New Formulation (44 mcg tiw and 44 mcg ow) in subjects at high risk of converting to Multiple Sclerosis

The primary objective of the study is to evaluate the effect of Rebif New Formulation 44 mcg (tiw and ow) versus placebo on the time to conversion to McDonald MS in patients with a first clinical demyelinating event at high risk of converting to MS…

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects with Relapsing-Remitting Multiple Sclerosis

North America, Europe, and rest of worldThe primary objective of this study is to determine whether BG00012, when compared with placebo, is effective in reducing the proportion of relapsing subjects at 2 years.The secondary objectives of this study…

Sirolimus (Rapamune®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes

The primary objective of the trial is to study the efficacccy of sirolimus in paraneoplastisch neurological syndromes associated with anti-Hu antibodies (Hu-PNS)Secondary objectives are to correlate clinical improvement with anti-Hu antibody titers…

Natalizumab (Tysabri®) for the treatment of anti-Hu associated paraneoplastic neurological syndromes

The primary objective of the study is the functional improvement with one point or more on the modified Rankin scale after the 12th week of natalizumab (compared to baseline).

A 96-week, prospective, multicenter, randomised, double-blind, placebo-controlled, 2-parallel groups, Phase 3 study to compare efficacy and safety of masitinib 4.5 mg/kg/day versus placebo in the treatment of patients with primary progressive or relapse-free secondary progressive multiple sclerosis

The objective of the study is to compare the safety and efficacy of masitinib at 4.5 mg/kg/day or masitinib at 4.5 mg/kg/day with a dose escalation to 6 mg/kg/day after three month of treatment versus placebo in the treatment of patients with…

A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

This study has been transitioned to CTIS with ID 2023-505974-14-00 check the CTIS register for the current data. Main objective:English To evaluate the longer-term safety of ocrelizumab in participants diagnosed with MS who were previously enrolled…

Neuroinflammation and post-infectious fatigue in individuals with and without Covid-19

The aim of this study is to quantify neuroinflammation and whole-body inflammation with [18F]DPA-714 PET scans in post-COVID-19 patients and relate it to cognitive, psychiatric and post-infectious fatigue symptoms.

Imlifidase treatment for acute inflammation in AQP4-IgG associated neuromyelitis optica spectrum disorder

To analyse in what proportion of NMOSD patients with an episode of acute inflammation circulating pathogenic anti-AQP4 IgG antibodies are depleted below detection limits, as measured with a state-of-the-arts cell-based assay, in the timeframe within…