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NCT ID: NCT02674386 Completed - Osteoarthritis Clinical Trials

Long-term Observational Study of Subjects From Tanezumab Studies Who Undergo a Total Knee, Hip or Shoulder Replacement

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

A4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. The study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. There will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).

NCT ID: NCT02670915 Completed - Diabetes Clinical Trials

Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 Diabetes

onset®7
Start date: May 4, 2016
Phase: Phase 3
Study type: Interventional

This trial is conducted globally. The aim of the trial is to investigate efficacy and safety of faster-acting insulin aspart compared to NovoRapid® both in combination with insulin degludec in children and adolescents with type 1 diabetes.

NCT ID: NCT02670538 Completed - Depression Clinical Trials

Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of the Depressive Episode in Participants With Bipolar I Disorder

Start date: March 31, 2016
Phase: Phase 3
Study type: Interventional

This study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

NCT ID: NCT02669758 Completed - Schizophrenia Clinical Trials

A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia

Start date: January 20, 2016
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long term safety and tolerability of ALKS 3831 in subjects with schizophrenia.

NCT ID: NCT02668653 Completed - Leukemia Clinical Trials

Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)

QuANTUM-First
Start date: September 1, 2016
Phase: Phase 3
Study type: Interventional

Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research. Adults might be able to join this study after bone marrow tests show they have a certain kind of blood cancer (FLT3-ITD AML). Participants will have an equal chance of receiving quizartinib or placebo along with their chemotherapy.

NCT ID: NCT02665845 Completed - Ulcerative Colitis Clinical Trials

Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).

COMBOMESA
Start date: June 13, 2016
Phase: Phase 3
Study type: Interventional

The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA) agents in the form of mesalamine/mesalzine are well established proven therapy in mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the flare is controlled. If this is unhelpful, or if the flare is severe to begin with, corticosteroids are usually prescribed. However, there are very scarce data comparing steroids versus 5-ASA in the treatment of severe UC exacerbation. The aim of this study is to compare the efficacy of steroids alone vs. combination of steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.

NCT ID: NCT02647866 Completed - Ulcerative Colitis Clinical Trials

Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis

Start date: June 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC) followed by a Long-term Extension Therapy (LTE) phase for eligible subjects with a clinical response.

NCT ID: NCT02640612 Completed - Clinical trials for Arthritis, Rheumatoid

Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis

Start date: January 22, 2016
Phase: Phase 3
Study type: Interventional

The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and immunogenicity data on BI 695501 administered via prefilled syringe in patients with Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the number (proportion) of patients with drug-related adverse events (AEs) during the treatment phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI 695501 by evaluation of: - the change from Baseline in DAS28 (ESR) at Week 48 - the proportion of patients meeting American College of Rheumatology 20% (ACR20) response criteria at Week 48 - the proportion of patients who meet the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) definition of remission at Week 48 - the proportion of patients with EULAR response (good response, moderate response, or no response) at Week 48.

NCT ID: NCT02638259 Completed - Clinical trials for Rheumatoid Arthritis

Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis

EQUIRA
Start date: February 21, 2015
Phase: Phase 3
Study type: Interventional

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).

NCT ID: NCT02634346 Completed - Schizophrenia Clinical Trials

A Study of ALKS 3831 in Adults With Acute Exacerbation of Schizophrenia (the ENLIGHTEN-1 Study)

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

This study will evaluate the efficacy of ALKS 3831 in adult subjects with acute exacerbation of schizophrenia.