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NCT ID: NCT02706951 Completed - Clinical trials for Rheumatoid Arthritis

A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

Start date: March 23, 2016
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 of this study is to compare the safety and efficacy (signs and symptoms) of upadacitinib 30 mg once daily (QD) alone and upadacitinib 15 mg QD alone versus continuing MTX alone adults with moderately to severely active rheumatoid arthritis (RA) with an inadequate response to MTX. The study objective of Period 2 is to evaluate the long term safety, tolerability, and efficacy of upadacitinib 30 mg QD and 15 mg QD in adults with RA who had completed Period 1.

NCT ID: NCT02706873 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Adults With Rheumatoid Arthritis (RA) Who Have Not Previously Taken Methotrexate

SELECT-EARLY
Start date: February 23, 2016
Phase: Phase 3
Study type: Interventional

The objectives of Period 1 were the following: - To compare the safety and efficacy of upadacitinib 7.5 mg once daily (QD) monotherapy (for participants in Japan only), 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate monotherapy for the treatment of signs and symptoms of RA in methotrexate-naïve adults with moderately to severely active RA; - To compare the efficacy of upadacitinib 15 mg QD monotherapy and upadacitinib 30 mg QD monotherapy versus weekly methotrexate monotherapy for prevention of structural progression in methotrexate-naïve adults with moderately to severely active RA. The objective of Period 2 is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 7.5 mg QD (for participants in Japan only), 15 mg QD, and 30 mg QD in adults with RA who have completed Period 1.

NCT ID: NCT02706847 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Compare Upadacitinib (ABT-494) to Placebo in Adults With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) With an Inadequate Response or Intolerance to Biologic DMARDs

SELECT-BEYOND
Start date: March 15, 2016
Phase: Phase 3
Study type: Interventional

The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of upadacitinib 30 mg once daily (QD) and 15 mg QD versus placebo for the treatment of signs and symptoms of participants with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD. The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.

NCT ID: NCT02702388 Completed - Thyroid Cancer Clinical Trials

A Trial of Lenvatinib (E7080) in Subjects With Iodine-131 Refractory Differentiated Thyroid Cancer to Evaluate Whether an Oral Starting Dose of 18 Milligram (mg) Daily Will Provide Comparable Efficacy to a 24 mg Starting Dose, But Have a Better Safety Profile

Start date: June 8, 2017
Phase: Phase 2
Study type: Interventional

This is a multicenter, randomized, double-blind study being conducted as a postmarketing requirement to the US Food and Drug Administration (FDA) to evaluate whether there is a lower starting dosage of lenvatinib 24 mg once daily (QD) that provides comparable efficacy but has a better safety profile in participants with radioiodine-refractory differentiated thyroid cancer RR-DTC with radiographic evidence of disease progression within the prior 12 months.

NCT ID: NCT02702180 Completed - Clinical trials for Autoimmune Pulmonary Alveolar Proteinosis

Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis

IMPALA
Start date: March 21, 2016
Phase: Phase 2
Study type: Interventional

This study evaluates inhaled molgramostim (recombinant human granulocyte macrophage-colony stimulating factor [rhGM-CSF]) in the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) patients. A third of the patients will receive inhaled molgramostim once daily for 24 weeks, a third will receive inhaled molgramostim intermittently (7 days on, 7 days off) for 24 weeks and a third will receive inhaled matching placebo for 24 weeks.

NCT ID: NCT02700919 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Efficacy and Safety of BCT197 in Subjects With Acute Respiratory Exacerbations of Chronic Obstructive Pulmonary Disease

Start date: August 1, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of BCT197 when added on to standard of care in adult subjects with acute respiratory exacerbations of chronic obstructive pulmonary disease requiring hospitalization. Additionally, the study will characterize the pharmacokinetics of BCT197 in adults with COPD. The total duration of the study will be 26 weeks. Subjects will receive study treatment administration over a period of 5 days after randomization. It is expected that approximately 255 subjects will complete the study and follow-up.

NCT ID: NCT02700815 Completed - Acute Pain Clinical Trials

Capsaicin + Diclofenac Gel in Acute Back Pain or Neck Pain

Start date: May 9, 2016
Phase: Phase 3
Study type: Interventional

This randomised, controlled multi-centre parallel group trial will assess the efficacy and tolerability of a topical formulation gel of the combination of diclofenac and capsaicin in comparison to gels with diclofenac alone, capsaicin alone, and placebo for the treatment of acute back pain or neck pain

NCT ID: NCT02700568 Completed - Clinical trials for Carcinoma, Renal Cell

Axitinib in Metastatic Renal Cell Carcinoma Patients With Favorable Prognostic Factors

FavorAx
Start date: January 2016
Phase: Phase 2
Study type: Interventional

Aim of the FavorAx study is to evaluate preliminary efficacy and safety of Axitinib in metastatic renal cell carcinoma patients with favorable IMDC prognostic factors who had progressed on sunitinib or pazopanib in the first-line setting.

NCT ID: NCT02699840 Completed - Meningitis Clinical Trials

Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation

Start date: February 2016
Phase:
Study type: Observational

The aim of this study is to generate local data on the safety of Menactra® in individuals 2 to 55 years of age in the Russian Federation. Primary Objective: - To describe the safety profile after 1 dose of Menactra® administered in individuals 2-55 years of age under standard health care practices.

NCT ID: NCT02699060 Completed - Clinical trials for Gastroesophageal Reflux Disease (GERD)

Experimental Study to Determine the Effects of Human Refluxate on Macrophage Phenotype and Its Correlation With GERD

Start date: February 2016
Phase: N/A
Study type: Interventional

This study is proposed to evaluate the role of motoric dysfunctions and type of refluxate in GERD patients, analyzed the blood monocyte/macrophage phenotypes of gastroesophageal reflux diseases (GERD) patients.