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NCT ID: NCT02762838 Completed - Clinical trials for Rheumatoid Arthritis

Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

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

BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid arthritis.

NCT ID: NCT02762812 Completed - Clinical trials for Ankylosing Spondylitis

Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis

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

BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with ankylosing spondylitis. BCD-055 is biosimilar of infliximab (JSC "BIOCAD", Russia)

NCT ID: NCT02760433 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Were Taking an Existing Medication Called a Tumour Necrosis Factor Alpha Inhibitor But Had Active Disease

CREDO 3
Start date: January 25, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with an existing medication called a tumour necrosis factor alpha inhibitor The primary objective of this study was to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active rheumatoid arthritis (RA) inadequately controlled by TNF-α inhibitor (TNFi) therapy.

NCT ID: NCT02760407 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of the Efficacy and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo and Adalimumab, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

CREDO 2
Start date: June 6, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving but not fully responding to treatment with methotrexate (MTX). The primary objective of this study was to evaluate the efficacy of OKZ 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active RA inadequately controlled by MTX therapy. The secondary objective was to evaluate the efficacy of OKZ relative to adalimumab in subjects with moderately to severely active RA inadequately controlled by MTX therapy.

NCT ID: NCT02760368 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of the Effectiveness and Safety of Two Dosing Regimens of Olokizumab (OKZ), Compared to Placebo, in Subjects With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate But Have Active Disease

CREDO 1
Start date: May 19, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine how effective and safe the study drug Olokizumab was in patients with Rheumatoid Arthritis (RA) who had been already receiving, but not fully responding to treatment with methotrexate (MTX). The primary objective of this study was to evaluate the efficacy of olokizumab (OKZ) 64 mg administered subcutaneously (SC) once every 2 weeks (q2w) or once every 4 weeks (q4w) relative to placebo in subjects with moderately to severely active rheumatoid arthritis (RA) inadequately controlled by methotrexate (MTX) therapy.

NCT ID: NCT02758912 Completed - Angina Pectoris Clinical Trials

Clinical Study of Medicinal Product Cardionat® Using in Health Athlete Volunteers

Start date: November 2016
Phase: Phase 4
Study type: Interventional

The objective of this study is to evaluate the long-term plasma and urine pharmacokinetic parameters of Cardionat®, capsules 250 mg, when used in healthy athlete volunteers. The study consists of four steps: - Step 1. Screening - selecting healthy volunteers for inclusion in the study; - Step 2. Assignment in one of the study group, prescription of the study drug; - Step 3. Samples collections for pharmacokinetic analysis; - Step 4. Evaluation of pharmacokinetic data.

NCT ID: NCT02757963 Completed - Clinical trials for Prostatic Hyperplasia

Benign Prostatic Hyperplasia (BPH) Screening Tool Case Finding Study in Subjects >=50 Years

Start date: May 12, 2016
Phase: Phase 4
Study type: Interventional

This non-randomized, interventional study will be conducted in a general practice setting to assess the utility of a benign prostatic enlargement (BPE)/benign prostatic obstruction (BPO) screening tool in conjunction with prostate specific antigen (PSA) in finding men confirmed to have BPH on full urologist assessment of diagnostic test results. The tool may help a General Practitioners (GP) to identify subjects who may have BPH for further tests and improve the speed of referrals to specialists when this is appropriate. The utility of the screening tool will be compared to the validated tool in wide clinical use, the International Prostate Symptom Score (IPSS). This study does not have any formal hypothesis in terms of the primary and secondary endpoint proportions. A BPE/BPO screening tool identifies lower urinary tract symptoms (LUTS) probably due to BPH in men not yet presenting with LUTS. The results of this screening tool will be used for further investigation. All subjects testing positive on the BPE/BPO screening tool (score >=3) tool or on the IPSS (score >=8) will be enrolled and offered a PSA test and urinalysis to establish a diagnosis of probable BPH (Part I-Visit 1). The GP may perform a digital rectal examination (DRE) which will be repeated by the urologist to confirm the diagnosis and to rule out an abnormality suggesting prostate cancer. The GP will make a diagnosis of probable BPH based upon screening results and lab tests which suggest that they are related to BPH and not other causes of such symptoms. The GP will phone the subject to report yes or no for probable BPH Part II (Visit 2). If the subject has probable BPH, the GP will schedule the subject for Visit 3 with an urologist. If the subject does not have probable BPH, then it will be considered that the subject has completed the study. Subjects that proceed to Part II (Visit 3) will be scheduled for a urology assessment performed by an urologist. This assessment includes a DRE and a brief physical exam and review of the PSA test, for a confirmatory diagnosis of BPH and estimation of risk of progression of BPH. Approximately 1,500 subjects presenting to a GP for reasons unrelated to this study will be screened for probable BPH to yield 500 subjects being referred to an urologist. The duration of the study will be 1 week (+/- 4 days) and up to 6 weeks to allow for GP and urologist visit scheduling.

NCT ID: NCT02757443 Completed - Clinical trials for Cardiac Surgical Procedures

Myocardial Protection With Phosphocreatine in High-RIsk Cardiac SurgEry Patients

PRISE
Start date: June 2016
Phase: Phase 3
Study type: Interventional

There is evidence on the role of the phosphotransfer system in the energy metabolism of the heart, with altered energetics playing an important role in the mechanisms of heart failure. Phosphocreatine plays an important part in the energy heart system. The investigators have just performed a systematic review and meta-analysis of randomized controlled trials (RCTs) and matched studies that compared phosphocreatine with placebo or standard treatment in patients with coronary artery disease or chronic heart failure or in those undergoing cardiac surgery. Patients receiving phosphocreatine had lower all-cause mortality as well as improved cardiac outcomes when compared to the control group, however, the quality of the included studies was low. Thus, the investigators plan to conduct an exploratory high quality RCT to investigate whether providing phosphocreatine compared to placebo improves the myocardial protection in high-risk patients scheduled for cardiac surgery and to determine the best research endpoint for future trials.

NCT ID: NCT02757352 Completed - Clinical trials for Axial Spondyloarthritis

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

COAST-X
Start date: August 2, 2016
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

NCT ID: NCT02756832 Completed - Diabetes Mellitus Clinical Trials

An Observational Study of Alogliptin Benzoate in Participants With Diabetes Mellitus Type 2

Start date: September 20, 2016
Phase:
Study type: Observational

The purpose of this study is to evaluate the effect of alogliptin benzoate (VIPIDIA®) on glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2 (T2DM) at Month 6.