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NCT ID: NCT03996369 Completed - Ulcerative Colitis Clinical Trials

Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis

ELEVATE UC 12
Start date: September 15, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).

NCT ID: NCT03995810 Completed - Multiple Sclerosis Clinical Trials

Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

CARMUS
Start date: June 15, 2019
Phase: N/A
Study type: Interventional

Low levels of tissue carnosine and mitochondrial dysfunction appears to accompany multiple sclerosis (MS), with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.

NCT ID: NCT03992430 Active, not recruiting - Clinical trials for Muscular Dystrophy, Duchenne

A Study to Compare Safety and Efficacy of a High Dose of Eteplirsen in Participants With Duchenne Muscular Dystrophy (DMD) (MIS51ON)

Start date: July 13, 2020
Phase: Phase 3
Study type: Interventional

This study will be comprised of 2 parts: Part 1 (dose escalation) will be conducted to evaluate the safety and tolerability of 2 doses (100 milligrams/kilogram [mg/kg] and 200 mg/kg) of eteplirsen in approximately 10 participants with DMD; Part 2 (dose finding and dose comparison) will be conducted for the selection of a high dose (100 mg/kg versus 200 mg/kg) and its comparison with the 30 mg/kg dose of eteplirsen, in approximately 144 participants with genetically confirmed deletion mutations amenable to treatment by skipping exon 51.

NCT ID: NCT03991728 Recruiting - Clinical trials for Temporomandibular Joint Disorders

Alloplastic Total Temporomandibular Joint (TMJ) Replacement Registry

Start date: October 15, 2019
Phase:
Study type: Observational [Patient Registry]

Prospective data will be collected in approximately 200 patients treated with an TMJ replacement. Patients will be followed up according to the standard (routine) for up to 5 years after the treatment. Data collection will include underlying disease, treatment details, functional and patient reported outcomes (PRO)s and anticipated or procedure-related adverse events (i.e. complications). This registry is designed to be able to assess the number of patients who refuse alloplastic total TMJ replacement. Therefore, the participating sites are asked to register all cases of refused TMJ replacements too.

NCT ID: NCT03980483 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

contRAst 1
Start date: May 16, 2019
Phase: Phase 3
Study type: Interventional

This study [contRAst 1 (201790: NCT03980483)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. The study will consist of a screening phase of up to 6 weeks followed by a 52-week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with MTX. Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

NCT ID: NCT03980041 Completed - Bladder Cancer Clinical Trials

Study to Evaluate the Efficacy/Safety of IPI-549 in Combination With Nivolumab in Patients With Advanced Urothelial Carcinoma (MARIO-275)

Start date: September 25, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to measure the effect of IPI-549 in combination with nivolumab when compared to nivolumab monotherapy in advanced urothelial cancer patients.

NCT ID: NCT03978000 Active, not recruiting - Clinical trials for Necrotizing Enterocolitis

IBP-9414 for the Prevention of Necrotizing Enterocolitis - The Connection Study

Start date: July 4, 2019
Phase: Phase 3
Study type: Interventional

IBP-9414 will be evaluated in preterm infants with a birth weight of 500-1500g, compared to placebo with regards to efficacy and safety in the prevention of necrotizing enterocolitis.

NCT ID: NCT03971422 Completed - Clinical trials for Generalized Myasthenia Gravis

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).

NCT ID: NCT03969888 Completed - Cystic Fibrosis Clinical Trials

A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222

Start date: December 11, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, tolerability, and efficacy of ABBV-3067 given alone and in combination with various doses of ABBV-2222 in adults with Cystic Fibrosis who are homozygous for the F508del mutation.

NCT ID: NCT03968159 Completed - Clinical trials for Adjunctive Treatment of Major Depressive Disorder

Adjunctive Pimavanserin in Subjects With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

Start date: April 25, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of adjunctive pimavanserin compared to placebo in subjects with major depressive disorder who have an inadequate response to antidepressant therapy