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NCT ID: NCT01715285 Completed - Prostate Neoplasms Clinical Trials

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC)

Start date: February 12, 2013
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate plus low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

NCT ID: NCT01713426 Completed - Clinical trials for Postherpetic Neuralgia (PHN)

A Study to Compare QUTENZA With Pregabalin for the Treatment of Peripheral Neuropathic Pain (PNP) After 8 Weeks of Treatment

ELEVATE
Start date: July 11, 2012
Phase: Phase 4
Study type: Interventional

This study is comparing the efficacy and tolerability of Qutenza with that of pregabalin in patients suffering from peripheral neuropathic pain. Treatment allocation will be to one of these treatments and the duration of the study will be about 10 weeks (assuming that from screening to treatment allocation takes 2 weeks). Participants will be asked to complete questionnaires about various aspects relating to their condition throughout the study. This study will include subjects suffering from Postherpetic Neuralgia, Peripheral Nerve Injury or Non Diabetic peripheral polyneuropathy.

NCT ID: NCT01712789 Completed - Multiple Myeloma Clinical Trials

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma

STRATUS
Start date: November 6, 2012
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate the safety and efficacy and to generate PK and biomarker data for the combination of pomalidomide and low-dose dexamethasone in patients with refractory or relapsed and refractory multiple myeloma. The study consists of a Screening phase within 28 days prior to cycle 1 day 1, a Treatment phase and a Follow-up phase which starts within 28 days of discontinuation from study treatment, every 3 months for up to 5 years. In addition, the collection of steady-state PK data from a large population will enable robust population PK and assess Pomalidomide exposure response analyses. The exploratory objectives of the study are to investigate potential markers predictive of POM response or resistance and pharmacodynamic markers.

NCT ID: NCT01712438 Completed - Severe Hemophilia A Clinical Trials

Human Cell Line-derived Recombinant Factor VIII (Human-cl-rhFVIII) in Previously Untreated Patients

Start date: February 2013
Phase: Phase 3
Study type: Interventional

Investigate the inhibitor development rate of Human cl rhFVIII in previously untreated patients with severe Hemophilia A.

NCT ID: NCT01711359 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Participants With Moderate to Severe Rheumatoid Arthritis

RA-BEGIN
Start date: November 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether baricitinib therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).

NCT ID: NCT01710358 Completed - Clinical trials for Rheumatoid Arthritis

A Study in Moderate to Severe Rheumatoid Arthritis

RA-BEAM
Start date: October 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

NCT ID: NCT01709578 Completed - Clinical trials for Rheumatoid Arthritis

To Evaluate The Effect Of SAR153191 (REGN88) Added To Other RA Drugs In Patients With RA Who Are Not Responding To Or Intolerant Of Anti-TNF Therapy (SARIL-RA-TARGET)

Start date: October 2012
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate that sarilumab added to disease modifying anti-rheumatic drugs (DMARDs) is effective for: - reduction of signs and symptoms at Week 24 and - improvement of physical function at Week 12 in patients with active rheumatoid arthritis (RA) who are inadequate responders or intolerant to tumor necrosis factor alpha (TNF-α) antagonists. Secondary Objectives: The secondary objectives are to investigate the effects of SAR153191 (REGN88) when added to DMARD therapy, in patients with active RA who are inadequate responders or intolerant to TNF-α antagonists, for: - Reduction of signs and symptoms at 12 weeks. - Improvement in physical function at Week 24. - Improvement in disease activity score as measured by other American College of Rheumatology derived components at Weeks 12 and 24. - Improvement in quality of life as measured by patient reported outcomes (PROs) at intermediate visits and Week 24. To assess the safety of sarilumab in this population. To assess the exposure of sarilumab added to DMARD therapy in this population.

NCT ID: NCT01709357 Completed - Clinical trials for Latent Myofascial Trigger Point of Upper Trapezius Muscle

Short and Medium-term Effects of Manual Therapy on Latent Myofascial Pain

Start date: September 2011
Phase: N/A
Study type: Interventional

The purpose of this study was to investigate the short and medium-term effects of three manual techniques on cervical range of motion and pressure pain sensitivity in subjects with mechanical stress, presenting latent trigger point of upper trapezius muscle.

NCT ID: NCT01705977 Completed - Clinical trials for Systemic Lupus Erythematosus

Belimumab Assessment of Safety in SLE

BASE
Start date: November 27, 2012
Phase: Phase 4
Study type: Interventional

The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE). This study mainly focuses on collecting information on serious events that are not that common or may only be seen with long-term treatment. These events include death, serious infections and other infections of interest, cancers, serious mental health problems, including depression and suicide, and serious infusion and hypersensitivity reactions. This study is being done to help understand if treatment with belimumab increases the risk for these types of events. This study will also see if patients receiving belimumab with other lupus medicines can reduce their use of steroids, such as prednisone, over 1 year.

NCT ID: NCT01705574 Completed - HIV Infections Clinical Trials

Safety and Efficacy of E/C/F/TDF Versus RTV-Boosted ATV Plus FTC/TDF in HIV-1 Infected, Antiretroviral Treatment-Naive Women

WAVES
Start date: October 24, 2012
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy of a regimen containing elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF) versus ritonavir (RTV)-boosted atazanavir (ATV/r) plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) in HIV-1 infected, antiretroviral treatment-naive adult women.