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NCT ID: NCT02294058 Completed - Multiple Sclerosis Clinical Trials

Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

SUNBEAM
Start date: December 3, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).

NCT ID: NCT02293967 Completed - Clinical trials for Relapsing-remitting Multiple Sclerosis

Mass Balance Study of MT-1303

Start date: September 2014
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the absorption, metabolism and excretion of MT-1303 in healthy subjects.

NCT ID: NCT02293889 Completed - Knee Osteoarthritis Clinical Trials

Impact of Physical Activity and Vitamin D on Osteoarthritic Knee Pain

Start date: March 2015
Phase: N/A
Study type: Interventional

Knee Osteoarthritis (KOA) is a major cause of pain and disability, particularly in those of increasing age and body fat. As there are no very effective therapies for KOA, disease often progresses until knee replacement surgery is needed. It has been observed Vitamin D and Physical Activity (PA) levels are lower in those with KOA, increased age and body fat. As the relationship between KOA, Vitamin D and PA levels are not clearly understood, this study aims to explore these relationships and the acceptability/feasibility of PA and Vitamin D interventions in those who would likely to benefit from these interventions. 200-300 people, 50-70 years, BMI 30-40kg/m2, meeting American College of Rheumatology (ACR) KOA Guidelines, will be recruited from North Tyneside and Liverpool Hospital trusts November 2014-January 2016 to participate in a single cross-sectional study visit, which will measure: Vitamin D/Calcium serum levels, BMI/Body Fat, mobility, Quality of life and pain (by questionnaire), and PA levels. Those participants with insufficient Vitamin D levels (25-50nmol/L) and PA levels (<30min moderate PA/week), will be invited to take part in a 3 month pilot RCT study. >64 people will be recruited for the pilot RCT and equally randomly allocated to 1 of 4 intervention groups: Vitamin D (1 capsule a day: 2000IU), Placebo (identical capsule: 1 a day), PA (online PA programme) and PA and Vitamin D. Additionally at the end of the 12 week study visit, up to 20 participants will be invited to take part in a qualitative interview exploring their experience during the two studies.

NCT ID: NCT02293863 Completed - Influenza Clinical Trials

A Study of MHAA4549A in Combination With Oseltamivir Versus Oseltamivir in Participants With Severe Influenza A Infection

Start date: January 14, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, placebo-controlled study that will investigate the safety and clinical activity of a single intravenous (IV) dose of MHAA4549A in adult participants hospitalized with severe influenza A in combination with oseltamivir versus a comparator arm of placebo with oseltamivir.

NCT ID: NCT02293460 Completed - Clinical trials for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Efficacy and Safety Study of I10E in Treatment of Patients With CIDP

PRISM
Start date: May 2015
Phase: Phase 3
Study type: Interventional

Primary objective: To assess the efficacy of I10E in improving the disability of patients with CIDP. Secondary objective: To assess the safety of I10E in patients with CIDP.

NCT ID: NCT02293382 Completed - Clinical trials for MPS IIIB (Sanfilippo Syndrome)

A Retrospective Chart Review of Deceased Patients With Mucopolysaccharidosis Type IIIB

Start date: July 2013
Phase: N/A
Study type: Observational

The objective is to perform a retrospective chart review to generate data to evaluate the clinical characteristics and course of disease progression of MPS IIIB.

NCT ID: NCT02293265 Completed - Asthma Clinical Trials

Cross-sectional Study for Identification and Description of Severe Asthma Patients

Start date: December 2014
Phase: Phase 3
Study type: Interventional

This will be a non-drug interventional cross-sectional study, where the screening visit and study visit can occur on the same day. Investigational product will not be administered. Approximately 790 subjects with severe asthma will be screened to achieve a total of at least 750 evaluable study subjects. The study will not include a run-in or follow-up period. This study will provide a more reliable description of the severe asthma patient landscape with respect to the potential eligibility for treatment with mepolizumab, omalizumab, and reslizumab. This study aims to estimate the potential overlap of patients eligible for treatment with mepolizumab and those eligible for treatment with omalizumab and/or reslizumab. Additionally, the current study will also ascertain and describe reslizumab eligibility with respect to both mepolizumab and omalizumab, in the severe asthma patient population.

NCT ID: NCT02293161 Completed - Autoimmune Diseases Clinical Trials

Single Ascending Doses Study of Anti- Interleukin-7 Receptor α Monoclonal Antibody (GSK2618960) in Healthy Volunteers

Start date: November 11, 2014
Phase: Phase 1
Study type: Interventional

GSK2618960 is a humanized Immunoglobulin G 1 ( IgG1) monoclonal antibody (mAb) that binds to the alpha component (CD127) of the heterodimeric Interleukin-7 receptor (IL-7R). It is being developed for the treatment of autoimmune indications. This study is intended to further explore the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of single ascending doses GSK2618960 in healthy volunteers beyond those already evaluated in I7R116702 (First Time In Human study). The study is anticipated to enrol 18 subjects in total, with 9 subjects in each of the two cohorts.

NCT ID: NCT02292784 Completed - Clinical trials for Obstetric Labour, Premature

Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies

ARIOS
Start date: June 1, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) treatment studies, to provide assurance that treatment is not associated with significant adverse outcomes in early childhood. The enrolled infants and children will be followed at pre-specified intervals until they reach 24 months chronological age. This study does not require medical interventions or study visits to an investigational site, instead, parents or legal guardians will be prompted at certain time points to complete developmental questionnaires and other data on their children's health status via an electronic device. Data collected during the infant and child follow up study will be managed by a centralized research coordinating center (RCC). Regionally based pediatricians will serve as study principal investigators (referred to as RCC-PIs) for this study. All communications the RCC-PI has with the parent/legal guardian or the child's health care provider (HCP) will occur remotely; there will be no clinic visits.

NCT ID: NCT02292654 Completed - Clinical trials for Sphingomyelin Lipidosis

Safety, Tolerability, PK, and Efficacy Evaluation of Repeat Ascending Doses of Olipudase Alfa in Pediatric Patients <18 Years of Age With Acid Sphingomyelinase Deficiency

ASCEND-Peds
Start date: May 1, 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Primary Objective: To evaluate the safety and tolerability of olipudase alfa administered intravenously in pediatric participants every 2 weeks for 64 weeks. Secondary Objective: To characterize the pharmacokinetic profile and evaluate the pharmacodynamics and exploratory efficacy of olipudase alfa administered intravenously in pediatric participants every 2 weeks for 64 weeks.