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NCT ID: NCT04134728 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of GSK3196165 (Otilimab) Versus Placebo and Sarilumab in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biological Disease-modifying Antirheumatic Drug (DMARDs) and/or Janus Kinase (JAK) Inhibitors

contRAst 3
Start date: October 31, 2019
Phase: Phase 3
Study type: Interventional

This study (contRAst 3 [202018: NCT04134728]) is a Phase 3, randomized, multicenter, double-blind study to assess the safety and efficacy of GSK3196165 in combination with conventional (cs) DMARD[s]) or the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to biologic (b) DMARD[s]) and/or JAK inhibitors. The study will consist of a screening phase of up to 6 weeks followed by 24 week treatment phase in which participants will be randomized in ratio of 6:6:6:1:1:1 to GSK3196165 150 milligrams (mg) subcutaneously (SC) weekly,GSK3196165 90 mg SC weekly, sarilumab 200 mg SC every other week or placebo (three arms) respectively, all in combination with background csDMARD(s). At Week 12, participants in the three placebo arms will switch from placebo to active intervention (either GSK3196165 150 mg SC weekly, GSK3196165 90 mg SC weekly, or sarilumab 200 mg SC every other week). 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]). Any participant who does not transition into study 209564 will undergo a safety follow-up visit at Week 34 (corresponding to 12 weeks after the last potential dose of sarilumab, at Week 22).

NCT ID: NCT04129554 Completed - Clinical trials for Hepatitis B, Chronic

A Study of JNJ 73763989+JNJ 56136379+Nucleos(t)Ide Analog (NA) Regimen Compared to NA Alone in e Antigen Negative Virologically Suppressed Participants With Chronic Hepatitis B Virus Infection

Start date: November 6, 2019
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy of 48-week study intervention with JNJ-73763989+JNJ-56136379+nucleos(t)ide analog (NA) regimen compared to NA alone assessed by HBsAg levels. This study is part of HepB Wings Platform Trial (PLATFORMPAHPB2001).

NCT ID: NCT04129164 Completed - Sjögren's Syndrome Clinical Trials

A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome

SS
Start date: October 16, 2019
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the efficacy, safety, and tolerability of VIB4920 (formerly MEDI4920) in adult participants with Sjögren's Syndrome (SS).

NCT ID: NCT04128579 Completed - Lupus Nephritis Clinical Trials

Study of EQ001 (Itolizumab) in Systemic Lupus Erythematosus With or Without Active Proliferative Nephritis

EQUALISE
Start date: October 1, 2019
Phase: Phase 1
Study type: Interventional

This is a multi-center study to evaluate the safety, tolerability, PK, PD, and clinical activity of itolizumab (EQ001) in subjects with Systemic Lupus Erythematosus with or without Active Proliferative Lupus Nephritis

NCT ID: NCT04124965 Completed - Clinical trials for Generalized Myasthenia Gravis

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Start date: October 29, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the MycarinGstudy is to evaluate the long-term safety, tolerability and long-term efficacy of rozanolixizumab in study participants with generalized myasthenia gravis (MG).

NCT ID: NCT04124926 Completed - Erosive Esophagitis Clinical Trials

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in Participants With Erosive Esophagitis

Start date: October 28, 2019
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy and safety of vonoprazan compared to lansoprazole in participants with erosive esophagitis.

NCT ID: NCT04122053 Completed - CYP1A2 Polymorphism Clinical Trials

Personalized Nutrition Caffeine Intake in Healthy Adults.

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Personalized nutrition is one of the most up to date trends in human nutrition and gains much interest of general public and scientists as well. Although we have gained some knowledge on gene-trait associations, the real effectiveness and usefulness of genotype-based nutritional recommendations is unknown. Many personalized nutrition companies are on the market today, some of them use personalized nutrition based on genotype analysis. For this reason, scientific basis of this approach should be clarified. Moreover, the effect of using genotype information in dietary interventions aimed at decreasing caffeine intake has never been tested. Our project can thus increase knowledge which can be applied in dietary counseling practice. Although we focus on caffeine intake, the study is designed as a proof of concept.

NCT ID: NCT04121936 Completed - Clinical trials for To Evaluate Lower Urinary Tract Symptoms (LUTS) in Poland

The Prevalence of Lower Urinary Tract Symptoms (LUTS) in Poland

Start date: November 11, 2019
Phase:
Study type: Observational

The first large population-based study to evaluate lower urinary tract symptoms (LUTS) in Poland. The study objective is to assess the prevalence and bother of LUTS in the population aged ≥40 years in Poland.

NCT ID: NCT04120402 Completed - Clinical trials for Osteoarthritis, Knee

Study to Evaluate the Efficacy and Safety of EP-104IAR in Patients With Osteoarthritis of the Knee

Start date: September 10, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, efficacy and pharmacokinetics (PK) of EP-104IAR in patients with osteoarthritis (OA) of the knee

NCT ID: NCT04119843 Completed - Clinical trials for Severe Renal Impairment

Safety and Diagnostic Efficacy of Mangoral in Participants With Focal Liver Lesions and Reduced Kidney Function

SPARKLE
Start date: February 19, 2020
Phase: Phase 3
Study type: Interventional

The overall objective of this study is to evaluate the safety and diagnostic efficacy of Mangoral in liver MRI in participants with known or suspected focal liver lesions and severe renal impairment. The diagnostic efficacy of Mangoral will be assessed in terms of visualization of detected focal liver lesions in combined MRI (CMRI: combined Mangoral-enhanced and unenhanced MRI) compared to unenhanced MRI.