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NCT ID: NCT01711736 Completed - Influenza Clinical Trials

Study to Evaluate Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Quadrivalent Influenza Vaccine GSK2282512A When Administered to Children 6 to 35 Months of Age

Start date: November 1, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the immunogenicity, reactogenicity and safety of the new influenza vaccine GSK2282512A (FLU-Q-QIV) and compare its activity to the marketed vaccine Fluarix® (TIV) in young children 6 to 35 months of age.

NCT ID: NCT01711658 Completed - Clinical trials for Non-HPV Locally Advanced Head and Neck Cancer

TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.

TRYHARD
Start date: March 15, 2013
Phase: Phase 2
Study type: Interventional

PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the human papillomavirus (HPV).

NCT ID: NCT01711359 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Participants With Moderate to Severe Rheumatoid Arthritis

RA-BEGIN
Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

NCT ID: NCT01711164 Completed - Clinical trials for Chronic Hepatitis C Infection

The Role of FGL2-FcgammaRIIB Inhibitory Pathway in Human Viral Hepatitis

Start date: January 2014
Phase: N/A
Study type: Observational

Viral hepatitis is a serious world health problem affecting over 1 billion people worldwide. Presently the lack of highly effective treatments results in many patients requiring liver transplantation or death. The investigators have defined the role of a unique molecule FGL2 and its receptor fc-gammaR and its role in the pathogenesis of both experimental and human hepatitis. The studies proposed in the present proposal will test the hypothesis that measuring levels of fgl2 in plasma will identify individuals that will go on to develop chronic disease and inhibition of binding of fgl2 to its receptor will allow the host with both acute and chronic disease to develop an appropriate immune response and clear the virus. The studies will provide rationale for generation of new therapies to improve the treatment of patients with acute and chronic viral hepatitis by targeting fgl2.

NCT ID: NCT01711138 Completed - Physical Activity Clinical Trials

An Intervention Study to Assess the Role of the Built Environment on Physical Activity and Active Transportation to School in Children and Youth

ASAP-Jr
Start date: October 2012
Phase:
Study type: Observational

The purpose of this study is to evaluate if changes to the built environment influence physical activity and active transport to school in children and youth.

NCT ID: NCT01710709 Completed - Bipolar I Clinical Trials

Open-label Study to Evaluate the Effectiveness of an Intramuscular Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Bipolar I Disorder

ATLAS
Start date: November 2012
Phase: Phase 3
Study type: Interventional

This will be an open-label uncontrolled trial to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for up to 52 weeks to patients with bipolar I disorder. The trial will enroll subjects who completed Trial 31-08-250 and de novo subjects not participating in Trial 31-08-250.

NCT ID: NCT01710358 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Moderate to Severe Rheumatoid Arthritis

RA-BEAM
Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

NCT ID: NCT01709929 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety of Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

PREDICTIVE™
Start date: October 2005
Phase: Phase 3
Study type: Interventional

This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.

NCT ID: NCT01709578 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Start date: October 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is effective for: - reduction of signs and symptoms at Week 24 and - improvement of physical function at Week 12 in patients with active rheumatoid arthritis (RA) who are inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives are to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in patients with active RA who are inadequate responders or intolerant to TNF-α antagonists, for: - Reduction of signs and symptoms at 12 weeks. - Improvement in physical function at Week 24. - Improvement in disease activity score as measured by other American College of Rheumatology derived components at Weeks 12 and 24. - Improvement in quality of life as measured by patient reported outcomes (PROs) at intermediate visits and Week 24. To assess the safety of sarilumab in this population. To assess the exposure of sarilumab added to DMARD therapy in this population.

NCT ID: NCT01709513 Completed - Clinical trials for Hypercholesterolemia

Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)

Start date: September 30, 2012
Phase: Phase 3
Study type: Interventional

This is a randomized, double-blind, double-dummy, active-controlled, parallel-group, multi-national, multi-center study to compare alirocumab (REGN727/SAR236553) versus ezetimibe in participants with primary hypercholesterolemia and moderate, high, or very high CV risk, who are intolerant to statins. An atorvastatin arm is added to determine that the population selected in the study is a truly statin intolerant population by assessing skeletal muscle-related adverse events.