A randomized, double-blind, multiple-dose, placebo-controlled, parallel group study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of ACZ885 in patients with newly diagnosed type-1 diabetes mellitus (T1DM) • To assess the effect of ACZ885, in addition to standard of care, on the area under the curve of the stimulated C peptide after a mixed meal tolerance test conducted after 12 months’ treatment.

• Country None
• organs None
• Specialty None

A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 μg once daily with open label tiotropium 18 μg once daily versus open label tiotropium 18 μg once daily in patients with moderate to severe chronic obstructive pulmonary disease To demonstrate superiority of indacaterol 150 µg o.d. in combination with tiotropium 18 µg o.d. versus tiotropium 18 µg o.d. with respect to standardized AUC for FEV1 between 5 min – 8 h post-dose aft...

• Country None
• organs None
• Specialty None

A study of the BRAF inhibitor dabrafenib in combination with the MEK inhibitor trametinib compared to two placebos (inactive drugs) in the treatment of BRAF V600E/K mutation-positive melanoma after surgery To evaluate the efficacy of dabrafenib and trametinib combination therapy compared to two placebos with respect to relapse-free survival (RFS) in patients with completely resected, histologically conf...

• Country None
• organs None
• Specialty None

A randomized, controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective The two co-primary objectives of this study are: • To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient’s assessment of gout pain intensity...

• Country None
• organs None
• Specialty None

A 12-month, multi-center, randomized, open-label non-inferiority study of renal function and efficacy comparing concentration-controlled Certican® (1.5 mg/day starting dose) with reduced Neoral® dose versus MMF with standard Neoral® dose in de novo heart transplant recipients •To demonstrate that comparable (non-inferior) renal function (calculated creatinine clearance according to Cockroft-Gault) is achieved in cohorts of de novo heart recipients treated with Certican/red...

• Country None
• organs None
• Specialty None

Safety and Efficacy of QAX576 in Patients With Progressive Idiopathic Pulmonary Fibrosis (IPF) • To evaluate the safety and tolerability of multiple intravenous dosing of QAX576 in patients with IPF • To evaluate the effect of multiple intravenous dosing of QAX576 on lung function assessed b...

• Country None
• organs None
• Specialty None

A multi-centre, randomized, double-blind, placebo controlled, multiple-dose, 4-way cross-over study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma To assess the bronchodilator effect of orally inhaled indacaterol salts (maleate, xinafoate and acetate) in patients with persistent asthma compared with placebo as measured by mean change in FEV1 fro...

• Country None
• organs None
• Specialty None

A randomized open-label study of 400 mg versus 800 mg of Gleevec/Glivec (imatinib mesylate) in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (CML-CP) using molecular endpoints To establish whether 800 mg Gleevec/Glivec (as 400 mg bid) improves efficacy in newly diagnosed, previously untreated CML-CP patients as compared to 400 mg by the evaluation of the rate of molecular r...

• Country None
• organs None
• Specialty None

A randomized, double-blind, placebo-controlled, multi-center, two-period crossover study to investigate the bronchodilatory effect of 50µg NVA237 inhaled once daily in patients with Chronic Obstructive Pulmonary Disease (COPD) Investigate the bronchodilatory efficacy of 50µg NVA237 over 24 hours following 14 days treatment when compared to placebo.

• Country None
• organs None
• Specialty None

Study of efficacy and safety of VAY736 in patients with relapsing-remitting multiple sclerosis To determine if a monoclonal antibody VAY736 can reduce disease activity in relapsing-remitting multiple sclerosis (RRMS) as compared to placebo.

• Country None
• organs None
• Specialty None