14 results
Primary endpoint:- Successful desensitization for Mesalazine in ulcerative colitis patients with a presumed history of intolerance for Mesalazine. Secondary endpoint:- To investigate if a presumed intolerance for Mesalazine may be reproducible in a…
The primary objective of this study is to evaluate the efficacy (clinical and MRI) of switching tonatalizumab compared to receiving interferon β1-a or glatiramer acetate.
The objective of the study is to compare the efficacy and tolerability of mesalazine granules (3 g 5*ASA/d) vs. placebo for the prevention of recurrence of diverticulitis. Additionally, the safety and tolerability in the form of adverse events and…
Our main objective is to prove that extending dose intervals guided by serum concentrations of natalizumab, will not result in radiological or clinical disease activity.
To evaluate the efficacy of 9mg budesonide/day and 3g mesalazine/day compared to placebo for the induction of remission in lymphocitic colitis.
To evaluate the efficacy of rVIII-SingleChain in the treatment of major andminor bleeding events based on the investigator*s 4-point assessment scale
The study objectives are to determine the incidence rate of FVIII inhibitors, frequency of adverse events (AEs), and serious adverse events (SAEs) associated with the use of CSL627, to evaluate the PK of 50 IU/kg CSL627, and to evaluate the efficacy…
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…
Part 1:The primary objective of the study is to investigate whether treatment with natalizumab slows the accumulation of disability not related to relapses in subjects with SPMS. The secondary objectives of this study are to determine in this study…
Primary objectives1. What is the effect of stopping mesalazine in the maintenance setting of patients with quiescent CD?2. Can subgroups of CD patients, for example based on prior treatment (medical vs. surgical), localization of disease, disease…
1) Identify chemopreventive properties of mesalazine in patients at high risk of recurrent (nonfamilial) colorectal adenomas by evaluating the effect of treatment on apoptosis and proliferation in histologically normal sigmoid and rectal mucosa…
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).
The purpose of this study is to investigate the safety and tolerability of the new compound PB006 (natalizumab) when it is administered to healthy volunteers. PB006 has not been administered to humans before. It has been previously tested in the…
Primary Objective: Our objective is to validate the safety, measured by radiological disease activity, of personalized extended interval dosing of natalizumab to >=6 weeks (with an aim natalizumab trough concentration of 5 µg/ml) in a large…