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NCT ID: NCT02648347 Completed - Anemia Clinical Trials

Study to Evaluate Vadadustat for the Correction of Anemia in Participants With Non-dialysis-dependent Chronic Kidney Disease

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

A multicenter, randomized, open-label, active-controlled Phase 3 study for the correction of anemia and maintenance of hemoglobin (Hb) in participants with Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD)

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: NCT02646683 Completed - Crohn Disease Clinical Trials

A Study to Evaluate Efficacy, of Early Versus Late Use of Vedolizumab in Crohn's Disease: the LOVE-CD Study

LOVE-CD
Start date: July 2015
Phase: Phase 4
Study type: Interventional

This multi-centre open label study will involve a minimum of 260 patients in 2 cohorts: 86 patients with 'early CD' defined as disease duration < 24 months and no other treatments than corticosteroids and/or thiopurines and 174 patients with 'late CD' defined as active disease despite treatment with immunosuppressives and anti-TNF. Patients with intolerance to IS and anti-TNF will also be allowed in the latter group. Participants will be treated with 12 months of open label vedolizumab (study medication followed by commercial medication once reimbursement is available) and undergo monitoring of endoscopic, histological and clinical disease parameters. No randomization or blinding will be performed but the study management will ensure that recruitment in either study group is comparable for number and profile of patients (on/off steroids).

NCT ID: NCT02646657 Completed - Colitis, Ulcerative Clinical Trials

An Open Label Phase 4 Study to Evaluate Efficacy of Early Versus Late Use of Vedolizumab in Ulcerative Colitis

LOVE-UC
Start date: July 2015
Phase: Phase 4
Study type: Interventional

This multi-centre open label study will involve a minimum of 120 patients in 2 cohorts: 60 patients with 'early UC' defined as disease duration < 4 years and no other treatments than aminosalicylates and/or corticosteroids and 60 patients with 'late UC' defined as active disease despite treatment with immunosuppressives (IS) and/or anti-TNF. Patients wih intolerance to IS AND anti-TNF will also be allowed in the latter group. Participants will be treated with 12 months of open label vedolizumab and undergo monitoring of endoscopic, histological and clinical disease parameters. No randomization or blinding will be performed but the study management will make sure recruitment in either study group is comparable for number and profile of patients (extent of disease and on/off corticosteroids).

NCT ID: NCT02641015 Completed - Clinical trials for Urinary Tract Infections

Study to Assess Management and Outcomes of Hospitalised Patients With Complicated UTI (RESCUING)

RESCUING
Start date: December 2015
Phase: N/A
Study type: Observational

A retrospective observational study to assess the clinical management and outcomes of hospitalised patients with complicated urinary tract infection in countries with high prevalence of multidrug resistant gram-negative bacteria (COMBACTE-MAGNET,WP5)

NCT ID: NCT02640664 Completed - Clinical trials for Retinopathy of Prematurity (ROP)

Rainbow Extension Study

RainbowExt
Start date: June 16, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to evaluate the long term efficacy and safety of intravitreal ranibizumab compared with laser ablation therapy in patients who were treated for retinopathy of prematurity (ROP) in the core study CRFB002H2301 (NCT02375971)

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: NCT02638207 Completed - Clinical trials for Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy

Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy

CIDP
Start date: September 27, 2017
Phase: Phase 3
Study type: Interventional

Study to evaluate the Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(radiculo)neuropathy

NCT ID: NCT02636868 Completed - Clinical trials for Respiratory Distress Syndrome

The Safety and Efficacy of Lucinactant for Inhalation in Premature Neonates 26 to 32 Weeks Gestational Age

Start date: December 2015
Phase: Phase 2
Study type: Interventional

The primary objective of this study is to evaluate the safety and efficacy of lucinactant for inhalation administered as an aerosolized dose in two doses to preterm neonates 26 - 32 weeks gestational age who are receiving nasal continuous positive airway pressure (nCPAP) for Respiratory Distress Syndrome (RDS) compared to neonates receiving nCPAP alone.