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NCT ID: NCT03253796 Not yet recruiting - Spondyloarthritis Clinical Trials

Golimumab (MK-8259 / SCH900259) Treatment Withdrawal in Participants With Non-radiographic Axial Spondyloarthritis (MK-8259-038)

Start date: October 17, 2017
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the effect of treatment withdrawal vs continued treatment with golimumab (GLM) administered by subcutaneous (SC) injection on the incidence of a "flare" in non-radiographic axial spondyloarthritis over up to 12 months. The primary hypothesis is that continued treatment with golimumab is superior to treatment withdrawal, based on the percentage of subjects without a "flare" during up to 12 months of blinded therapy.

NCT ID: NCT03239860 Recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

ANGEL-MS
Start date: June 6, 2017
Phase: Phase 2
Study type: Interventional

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis. The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.

NCT ID: NCT03231280 Not yet recruiting - Osteoarthritis Clinical Trials

A Trial of a Single Delivery of SB-061 in Osteoarthritis of the Knee

MODIFY2
Start date: August 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates a novel agent, SB-061, for the treatment of osteoarthritis of the knee. Half of the patients will receive the agent via intra-articular injection and half will receive a placebo injection.

NCT ID: NCT03192969 Withdrawn - Clinical trials for Giant Cell Arteritis

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

Start date: July 15, 2017
Phase: Phase 3
Study type: Interventional

To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

NCT ID: NCT03181360 Recruiting - Ischemic Stroke Clinical Trials

Tenecteplase in Wake-up Ischaemic Stroke Trial

TWIST
Start date: June 12, 2017
Phase: Phase 3
Study type: Interventional

Stroke is a leading causes of death and disability. At least 20% of strokes occur during sleep, so- called 'wake up stroke'. Thrombolysis with the clot-busting drug alteplase is effective for acute ischaemic stroke, provided that it is given within 4.5 hours of symptom onset. Patients with wake-up stroke are currently ineligible for clot-busting therapy. Previous studies indicate that many wake-up strokes occur just before awakening. In this study, patients with wake-up stroke will be randomized to thrombolysis with tenecteplase and best standard treatment or to best standard treatment without thrombolysis. Tenecteplase has several potential advantages over alteplase, including very rapid action and that it can be given as a single injection. Prior to thrombolysis, a brain scan must be done to exclude bleeding or significant brain damage as a result from the stroke. We will use a CT scan to inform this decision. CT is used as a routine examination in all stroke patients. Other studies testing clot-busting treatment in wake-up stroke are using alteplase and more complex brain scans, which are not routinely available in the emergency situation in all hospitals.

NCT ID: NCT03171311 Recruiting - Clinical trials for Ischemic Heart Disease

The OCTOBER Trial - Nordic-Baltic-British Study on Optical Coherence Tomography Optimized Bifurcation Event Reduction

OCTOBER
Start date: July 2017
Phase: N/A
Study type: Interventional

The purpose is to compare median two-year clinical outcome after OCT guided vs. standard guided revascularization of patients requiring complex bifurcation stent implantation

NCT ID: NCT03162653 Not yet recruiting - Clinical trials for Infant, Newborn, Diseases

Effect of Allopurinol for Hypoxic-ischemic Brain Injury on Neurocognitive Outcome

ALBINO
Start date: June 2017
Phase: Phase 3
Study type: Interventional

Neonatal hypoxic-ischemic encephalopathy (HIE) is a major cause of death or long-term disability in infants born at term in the western world, affecting about 1-4 per 1.000 life births and consequently about 5-20.000 infants per year in Europe. Hypothermic treatment became the only established therapy to improve outcome after perinatal hypoxic-ischemic insults. Despite hypothermia and neonatal intensive care, 45-50% of affected children die or suffer from long-term neurodevelopmental impairment. Additional neuroprotective interventions, beside hypothermia, are warranted to further improve their outcome. Allopurinol is a xanthine oxidase inhibitor and reduces the production of oxygen radicals and brain damage in experimental, animal, and early human studies of ischemia and reperfusion. This project aims to evaluate the efficacy and safety of allopurinol administered immediately after birth to near-term infants with HIE in addition to hypothermic treatment.

NCT ID: NCT03158285 Recruiting - Clinical trials for Arthritis, Psoriatic

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis

Start date: July 12, 2017
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

NCT ID: NCT03145519 Recruiting - Clinical trials for Injections, Intravenous

A Trial to Demonstrate the Safety and Efficacy of the OptiVein IV Catheter In a Pediatric Population

Start date: February 15, 2017
Phase: N/A
Study type: Interventional

A prospective, single-center, open-label, randomized controlled trial to demonstrate the safety and efficacy of the OptiVein IV Catheter in the pediatric population. The study hypothesis is that OptiVein IV Catheter use will be superior to the control in successful venous access after first attempt.

NCT ID: NCT03120949 Recruiting - Clinical trials for Rheumatoid Arthritis

Evaluation of the Long Term Safety, Tolerability and Efficacy of Two Dosing Regimens of Olokizumab (OKZ), in Subjects With Rheumatoid Arthritis (RA) Who Previously Completed 24 Weeks of Blinded Treatment in One of the Core Studies - CREDO 1, 2 or 3.

CREDO 4
Start date: July 4, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study is to evaluate how safe, how effective and how well tolerated, the study drug Olokizumab is, in the long-term, in patients with Rheumatoid Arthritis (RA) who have previously taken part in and completed 24 weeks of blinded treatment in one of the core studies - CREDO 1, 2 or 3.