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A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…

A PHASE 3, RANDOMIZED, OPEN-LABEL, ACTIVE CONTROLLED, MULTICENTER STUDY TO EVALUATE MAINTENANCE OF RESPONSE, SAFETY AND PATIENT REPORTED OUTCOMES IN ACROMEGALY PATIENTS TREATED WITH OCTREOTIDE CAPSULES, AND IN PATIENTS TREATED WITH STANDARD OF CARE PARENTERAL SOMATOSTATIN RECEPTOR LIGANDS WHO PREVIOUSLY TOLERATED AND DEMONSTRATED A BIOCHEMICAL CONTROL ON BOTH TREATMENTS

* To assess maintenance of biochemical control of octreotide capsules compared to parenteral SRLs in patients with acromegaly, who previouslydemonstrated biochemical control on both treatments.* To assess symptomatic response to octreotide capsules…

Improving quality of survivorship for breast cancer-related lymphedema by lymphatic microsurgery: A randomized controlled trial

To assess the effectivity of LVA on arm volume in comparison to standard therapy after 12 months.

A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients With Duchenne Muscular Dystrophy

Primary Objective:The primary objective of this study is to evaluate the effect of SRP-4045 and SRP-4053 (combined-active group) compared to placebo onambulation, endurance, and muscle function at Week 96, as measured by the 6-minute walk test (6MWT…

A randomised, single dose, crossover, open label, placebo controlled confirmatory study with interim analysis in healthy volunteers to characterise the acid neutralisation activity of Gaviscon Double Action Tablets in the fasted state, using an intragastric and oesophageal pH catheter

The primary objective of this confirmatory study is to investigate the acid neutralisation action of Gaviscon Double Action Tablets versus placebo tablets, within the stomach.The secondary objective of this study is to assess the safety of the test…

Prostacyclin receptor agonist Selexipag in patients with pulmonary arterial hypertension and congenital heart disease

To determine whether addition of selexipag to current PAH therapy improves exercise capacity, imaging parameters and quality of life, delays time-to-first-PAH-related morbidity and mortality, prevents worsening of World Health Organization…

Efficacy and safety of liraglutide in combination with mettormin versus mettormin monotherapy on glycaemic control in children and adolescents with type 2 diabetes
A 26-week double-blind, randomised, parallel group, placebo controlled multi-centre trial followed by a 26-week open-label extension.

Primary objectiveTo confirm the superiority of liraglutide at the maximum tolerated dose (0.6 mg, 1.2 mg or 1.8 mg) versus placebo when added to metformin with or without basal insulin treatment in controlling glycaemia in children and adolescents (…

A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant

1. To determine the efficacy of QPI-1002 to reduce the incidence and severity of delayed graft function in comparison to placebo in recipients of a donation after brain death (DBD) older donor kidney.2. To assess the safety and tolerability of QPI-…

Free-hand versus navigation guided percutaneous liver tumor ablation

The objective of the study is to compare free-hand needle placement with navigation guided needle placement.

A Phase III, International, Randomized, Controlled Study of Rigosertib versus Physician*s Choice of Treatment in Patients with Myelodysplastic Syndrome after Failure of a Hypomethylating Agent

Primary:• To compare the overall survival (OS) of patients in the rigosertib group vs the Physician*s Choice group, in all patients and in a subgroup of patients with IPSS-R very high riskSecondary efficacy• To compare rigosertib to Physician*s…

A randomized, double-blindphase 3 study of vadastuximab talirine (SGN-CD33A)versus placebo in combination with azacitidine or decitabine in the treatment of older patients with newly diagnosed acute myeloid leukemia (AML)

Primary* To compare the composite complete remission (CRc) rate (morphologic complete remission [CR] and morphologic CR with incomplete hematologic recovery [CRi]) between treatment arms * To compare overall survival (OS) between treatment…

An Open-Label, Multicenter Evaluation of the Safety and Efficacy of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc; BIIB031) in the Prevention and Treatment of Bleeding in Previously Untreated Patients With Severe Hemophilia A

The purpose of this study is to investigate the safety and efficacy of rFVIIIFc in previously untreated patients (PUPs) in accordance with the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) guideline on the…

STING (Study of Immunotherapy in Newly Diagnosed Glioblastoma): A Phase III randomized double-blind, controlled study of ICT-107 with maintenance temozolomide (TMZ) in newly diagnosed glioblastoma following resection and concomitant TMZ chemoradiotherapy

Primary Objective* To determine the OS of subjects treated with ICT-107 and standard of care (RT and TMZ) vs. placebo control and standard of care (RT and TMZ) :Secondary Objectives* To determine the OS of subjects with unmethylated MGMT tumors…

A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)

The main aim of this project is to test the hypothesis that the presence or absence of specific synovial cellular and molecular signatures (B cells and B cell-associated signatures), assessed following a synovial tissue biopsy, will enrich for…

A Phase 3, Randomized, Open-Label, Active-Controlled Study of ALXN1210 Versus Eculizumab in Complement Inhibitor-Naïve Adult Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH)

The primary objective of this study is to assess the noninferiority of ALXN1210 compared to eculizumab in adult patients with PNH who have never been treated with a complement inhibitor. Noninferiority will be claimed if after 26 weeks of treatment…

Phase 3, prospective, multi-center, open label study to investigate
safety, immunogenicity, and hemostatic efficacy of PEGylated Factor VIII
(BAX 855) in previously untreated patients (PUPs) < 6 years with
severe hemophilia A (FVIII < 1%)

Primary Objective:The primary objective of the study is to determine the safety including immunogenicity of BAX 855 based on the incidence of inhibitor development to FVIII (* 0.6 Bethesda unit (BU)/mL using the Nijmegen modification of the Bethesda…