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NCT ID: NCT02743806 Terminated - Crohn Disease Clinical Trials

Extended Access Program of Vedolizumab IV in Ulcerative Colitis and Crohn's Disease

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

The purpose of this study is to monitor ongoing safety in participants with ulcerative colitis (UC) and Crohn's disease (CD) and to provide access to vedolizumab for qualifying participants who, in the opinion of the investigator, continue to derive benefit from vedolizumab and for whom continued treatment with vedolizumab is desired because there is no other comparable product available or the participant may be expected to develop worsening of disease if they were to modify treatment.

NCT ID: NCT02723773 Completed - Herpes Zoster Clinical Trials

A Long-term Follow-up Study (ZOE-LTFU) of Two Studies 110390 (ZOSTER-006) and 113077 (ZOSTER-022) to Assess the Efficacy, Safety, and Immunogenicity Persistence of GSK Biologicals' Herpes Zoster Subunit (HZ/su) Vaccine and Assessment of 1 or 2 Additional Doses in Two Subgroups of Older Adults

Start date: April 18, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is a long-term follow-up of the two studies 110390 and 113077 (ZOSTER-006/022) to assess the efficacy, safety, and immunogenicity persistence of GSK Biologicals' Herpes Zoster subunit (HZ/su) vaccine and will include an assessment of 1 or 2 additional doses in two subgroups of older adults.

NCT ID: NCT02721966 Completed - Clinical trials for Axial Psoratic Arthritis

Study of the Efficacy and Safety of Secukinumab in Participants With Active Psoriatic Arthritis With Axial Skeleton Involvement

MAXIMISE
Start date: October 3, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the efficacy and safety of secukinumab 150 mg or 300 mg in the management of axial manifestations in PsA patients who have failed to respond to at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) over a 4-week period, according to assessment of spondyloarthritis international society (ASAS) recommendations for the treatment of axial spondyloarthritis (AxSpA).

NCT ID: NCT02718417 Terminated - Ovarian Cancer Clinical Trials

Avelumab in Previously Untreated Patients With Epithelial Ovarian Cancer (JAVELIN OVARIAN 100)

Start date: May 19, 2016
Phase: Phase 3
Study type: Interventional

This is a Phase 3, open-label, international, multi-center, efficacy, and safety study of avelumab in combination with and/or following platinum-based chemotherapy. Eligible patients must have previously untreated, histologically confirmed Stage III-IV epithelial ovarian (EOC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) and be candidates for platinum-based chemotherapy. The primary purpose of the study is to demonstrate if avelumab given as single agent in the maintenance setting following frontline chemotherapy or in combination with carboplatin/paclitaxel is superior to platinum-based chemotherapy alone followed by observation in this population of newly diagnosed ovarian cancer patients.

NCT ID: NCT02717195 Completed - Schizophrenia Clinical Trials

Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

DayBreak
Start date: April 2016
Phase: Phase 3
Study type: Interventional

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

NCT ID: NCT02715804 Terminated - Clinical trials for Pancreatic Ductal Carcinoma

A Study of PEGylated Recombinant Human Hyaluronidase in Combination With Nab-Paclitaxel Plus Gemcitabine Compared With Placebo Plus Nab-Paclitaxel and Gemcitabine in Participants With Hyaluronan-High Stage IV Previously Untreated Pancreatic Ductal Adenocarcinoma

Start date: March 14, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of PEGylated Recombinant Human Hyaluronidase (PEGPH20) combined with nab-paclitaxel plus gemcitabine (PAG treatment), compared with placebo combined with nab-paclitaxel plus gemcitabine (AG treatment), in participants with hyaluronan (HA)-high Stage IV previously untreated pancreatic ductal adenocarcinoma (PDA).

NCT ID: NCT02714322 Completed - Psoriasis Clinical Trials

MYL-1401A Efficacy and Safety Comparability Study to Humira®

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

To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with moderate-to-severe chronic plaque psoriasis

NCT ID: NCT02709746 Completed - Clinical trials for Depressive Disorder, Major

Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)

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

Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).

NCT ID: NCT02709655 Completed - Clinical trials for Depressive Disorder, Major

Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Participants Aged 7 to 11 Years With Major Depressive Disorder (MDD)

Start date: May 18, 2016
Phase: Phase 3
Study type: Interventional

Investigation of the efficacy and safety of a new potential treatment of Major depressive disorder (MDD) in paediatric participants (age 7 to 11 years).

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.