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NCT ID: NCT01930890 Terminated - Lupus Nephritis Clinical Trials

BIIB023 Long-Term Extension Study in Subjects With Lupus Nephritis

Start date: November 2013
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety and tolerability of BIIB023 in participants with lupus nephritis (LN).

NCT ID: NCT01920477 Terminated - Pemphigus Vulgaris Clinical Trials

Efficacy and Safety of Ofatumumab in Treatment of Pemphigus Vulgaris

Start date: August 13, 2013
Phase: Phase 3
Study type: Interventional

Pemphigus vulgaris (PV) is a rare, chronic, debilitating, and potentially life-threatening autoimmune disorder that is characterized by mucocutaneous blisters. Ofatumumab is a novel monoclonal antibody (mAb) that specifically binds to the human CD20 antigen, which is expressed only in B lymphocytes. The purpose of this study was to evaluate the efficacy, tolerability, and safety of ofatumumab injection for subcutaneous use (ofatumumab SC) 20 milligrams (mg) administered once in every 4 weeks, (with an additional 20 mg loading dose [i.e. 40 mg total] at both Week 0 and Week 4) in subjects with PV. It was anticipated that with sustained B-cell depletion in the presence of ofatumumab SC, and the resultant reduction of pathogenic anti Dsg (desmoglein) autoantibodies in PV, that clinical remission of the disease would result.

NCT ID: NCT01910129 Terminated - Seizure Clinical Trials

Neurostimulation to the Vagus Nerve for the Reduction in Frequency of Seizures Associated With Epilepsy

Start date: July 2013
Phase: N/A
Study type: Interventional

The purpose of this study is to see the effects of non-invasive vagal nerve stimulation for the reduction in frequency of seizure associated with epilepsy in subjects 18 or older.

NCT ID: NCT01908751 Terminated - Clinical trials for Femoral Neck Fractures

Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2)

FAITH-2
Start date: September 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine the impact of surgical fixation (cancellous screws versus sliding hip screws) and biologic intervention (Vitamin D versus placebo) on patient important outcomes.

NCT ID: NCT01907100 Terminated - Mesothelioma Clinical Trials

Nintedanib (BIBF 1120) in Mesothelioma

Start date: September 19, 2013
Phase: Phase 2/Phase 3
Study type: Interventional

This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.

NCT ID: NCT01902290 Terminated - Asthma Clinical Trials

Study of Efficacy and Safety of Brodalumab Compared With Placebo in Adults With Inadequately Controlled Asthma With High Bronchodilator Reversibility

Start date: May 22, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if brodalumab (AMG 827) is safe and effective compared to placebo as measured by change in Asthma Control Questionnaire (ACQ) composite scores.

NCT ID: NCT01900665 Terminated - Alzheimer's Disease Clinical Trials

Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo

EXPEDITION 3
Start date: July 2013
Phase: Phase 3
Study type: Interventional

To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.

NCT ID: NCT01892345 Terminated - Clinical trials for Neuromyelitis Optica

A Randomized Controlled Trial of Eculizumab in AQP4 Antibody-positive Participants With NMO (PREVENT Study)

Start date: April 11, 2014
Phase: Phase 3
Study type: Interventional

The objectives of this time-to-event study were to assess the efficacy and safety of eculizumab as compared with placebo in participants with neuromyelitis optica spectrum disorder (NMOSD) who were anti-aquaporin-4 (AQP4) antibody-positive.

NCT ID: NCT01887912 Terminated - Clinical trials for Clostridium Difficile Infection

Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

Start date: July 30, 2013
Phase: Phase 3
Study type: Interventional

The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need. Primary objective: - To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged >= 50 years who are at risk for CDI and have received at least 1 injection. Secondary Objectives: Efficacy: - To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days. - To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections. Immunogenicity: - To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60. Safety: - To describe the safety profile of all participants who received at least 1 injection.

NCT ID: NCT01870609 Terminated - Clinical trials for Malignant Pleural Mesothelioma

Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma

COMMAND
Start date: September 2013
Phase: Phase 2
Study type: Interventional

This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study.