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NCT ID: NCT02831855 Completed - Clinical trials for Rheumatoid Arthritis

Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

Start date: September 1, 2016
Phase: Phase 4
Study type: Interventional

This study is designed to evaluate the efficacy and safety of tofacitinib modified release formulation (11mg QD) versus tofacitinib modified release formulation plus continued methotrexate treatment in subjects with moderate to severe rheumatoid arthritis who are insufficiently responding to their stable dose of methotrexate treatment.

NCT ID: NCT02813694 Completed - Clinical trials for Community Acquired Pneumonia

Study to Compare Lefamulin to Moxifloxacin for the Treatment of Adults With Pneumonia

LEAP2
Start date: August 2016
Phase: Phase 3
Study type: Interventional

This study evaluates the safety and efficacy of lefamulin, a pleuromutilin, for the treatment of adults with moderate community-acquired bacterial pneumonia

NCT ID: NCT02810457 Completed - Clinical trials for Carcinoma, Non-Small-Cell Lung

Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer

AVANA
Start date: September 7, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer

NCT ID: NCT02770170 Completed - Lupus Nephritis Clinical Trials

Dose Finding, Efficacy and Safety of BI 655064 in Patients With Active Lupus Nephritis

Start date: May 16, 2016
Phase: Phase 2
Study type: Interventional

The overall purpose of the study is to assess the efficacy of three different doses of BI 655064 against placebo as add-on therapy to standard of care (SOC) treatment for active lupus nephritis in order to characterize the dose-response relationship within the therapeutic range, and select the target dose for phase III development.

NCT ID: NCT02751931 Completed - Clinical trials for Neurogenic Detrusor Overactivity

Open-label Phase 3 Study With Mirabegron in Children From 3 to Less Than 18 Years of Age With Neurogenic Detrusor Overactivity

Crocodile
Start date: June 17, 2016
Phase: Phase 3
Study type: Interventional

The objective of the study was to evaluate the efficacy, safety, tolerability and pharmacokinetics of mirabegron after multiple-dose administration in the pediatric population.

NCT ID: NCT02716415 Completed - Diaper Dermatitis Clinical Trials

Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants

Start date: March 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants.

NCT ID: NCT02670863 Completed - Infant Term Birth Clinical Trials

Safety and Efficacy Study

Start date: January 21, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of the experimental formula supplemented with a prebiotic vs the control formula.

NCT ID: NCT02628444 Completed - Dengue Fever Clinical Trials

Immunogenicity and Safety of Different Vaccination Schedules of Tetravalent Dengue Vaccine in Healthy Subjects 9 to 50 Years of Age

Start date: May 2, 2016
Phase: Phase 2
Study type: Interventional

The aim of the study was to assess the immune response and the safety of different vaccination schedules of CYD dengue vaccine. The primary objectives of the study were: - To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants 28 days after the last injection. - To demonstrate the non-inferiority of the immune response elicited against each dengue serotype by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD vaccine given as a 3-dose schedule (Group 1) in previously dengue exposed participants, 1 year after the last injection. - To demonstrate the non-inferiority of the immune response elicited against each dengue serotype elicited by a booster dose of CYD dengue vaccine one year or two years after the last injection in the primary series in previously dengue exposed participants, compared to the immune response post dose 3 in Group 1. The secondary objectives of the study were: - To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants, 28 days after the last injection. - To demonstrate the superiority of the immune response elicited by CYD dengue vaccine given as a 2-dose schedule (Group 2) compared to the immune response elicited by CYD dengue vaccine given as a 3-dose schedule (Group 1), in previously dengue exposed participants, one year after the last injection. - To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 3 to the antibody levels immediately before receiving a booster dose, by baseline dengue serostatus. - To describe the neutralizing antibody levels of each dengue serotype at 28 days post-injection 2 and 28 days post-injection 3 from Group 1 in a primary series schedule by baseline dengue serostatus. - To demonstrate the superiority of the immune response elicited against each dengue serotype 28 days after administration of a booster dose of CYD dengue vaccine, in previously dengue exposed participants, at one year or two years after last injection in the primary series. - To describe the seroconversion rate 28 days post-booster injection in all 3 groups. - To describe all hospitalized virologically confirmed dengue (VCD) cases during the study. - To evaluate the safety profile of CYD after each and any injection during the trial. Safety assessments include solicited reactions within 7 or 14 days after each injection, unsolicited adverse events within 28 days after each injection, and serious adverse events during the study period.

NCT ID: NCT02624947 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Determine the Safety and Efficacy of the RSV F Vaccine to Protect Infants Via Maternal Immunization

Start date: December 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the efficacy of maternal immunization with the RSV F vaccine against symptomatic RSV lower respiratory tract infection (LRTI) with hypoxemia through the first 90 days of life in infants.

NCT ID: NCT02596230 Completed - Clinical trials for Venous Thromboembolism

RE-COVERY DVT/PE: Global Study on Treatment Secondary Prevention of Acute Venous Thromboembolism

Start date: November 5, 2015
Phase:
Study type: Observational

RE-COVERY is a large, multi-national, multi-center observational study based on new data collection. The study will enroll and characterize patients within 30 days of being diagnosed with an acute DVT and/or PE. The study has two main objectives. Objective 1 will characterize the DVT / PE patient population. All patients with a DVT and/or PE will be enrolled for cross-sectional characterization of the VTE patient population. Objective 2 will compare the safety and effectiveness of dabigatran etexilate regimens for treatment of VTE in comparison to VKA regimens. Patients treated with dabigatran etexilate or VKA will be followed up for the occurrence of outcome events for up to one year.