Clinical Trials About "Siegfried Biologics GmbH" RSS

21:19 EST 17th November 2018 | BioPortfolio

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Showing "Siegfried Biologics GmbH" Clinical Trials 1–25 of 129


A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)

The purpose of this study is to compare the efficacy of Biologics + Methotrexate with Biologics + Tacrolimus measured by the disease activity score 28 (DAS28) erythrocyte sedimentation rate (ESR) and the American College of Rheumatology (ACR) scores. The study will also assess the safety of the combinations.

Ustekinumab Safety and Surveillance Program Using the Ingenix NHI Database

The patients included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan. The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in psoriasis patients treated with ustekinumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biologics, or systemic non-biological treatments.

Golimumab Safety and Surveillance Program Using the Ingenix NHI Database

The participants included in this observational study will be drawn from a research database containing claims and enrollment data for members of a large, geographically diverse US health plan.The objective of this study is to estimate the rate of serious infections, tuberculosis, malignancies, and other outcomes in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis patients treated with golimumab, anti-tumor necrosis factor (TNF) biologics, non-anti-TNF biol...

Real World Effectiveness of Ustekinumab in Induction and Maintenance Therapy for Crohn´s Disease

"RUN-CD" is an investigator initiated "Non interventional Trial" on biologics in Crohn´s Disease (CD) patients in Germany with a prospective documentation of effectiveness in induction and maintenance therapy of biologics, especially of Ustekinumab, with a special interest on predictors of long-term responses and favorable disease outcome and documentation of severe side effects caused by the therapy with biologics.

Tight Control Dose Reductions of Biologics in Psoriasis Patients With Low Disease Activity

Rationale/hypothesis: Moderate-to-severe psoriasis can be treated with biologics. Objective To investigate whether the dose of biologics can be reduced in patients with psoriasis with stable disease. Study design: A pragmatic, multicentre, randomized, controlled, non-inferiority study with cost-effectiveness analysis. Study population: Patients with disease remission using normal dose of biologics. Intervention: 120 patients will be randomized into two groups: (1) dos...

Observational Study to Estimate the Effectiveness of Biologics When Treating Plaque Psoriasis

To estimate the real-world effectiveness of approved biologics in subjects with moderate-to-severe plaque psoriasis who are either starting or switching biologic medication.

Bioequivalence Study Comparing Two Test Products With One Reference Product, All Containing 5 mg Yohimbine

- Type: Bioequivalence study in male healthy volunteers, therapeutical indication (erectile disfunction) not studied - Products, dosage, and route of administration: - Test 1: Procomil 5 mg (Walter Ritter GmbH & Co. KG, Germany), sugar-coated tablet containing 5 mg yohimbine hydrochloride, oral administration - Test 2: Yohimbin "Spiegel"® (Desma GmbH, Germany), tablet containing 5 mg yohimbine hydrochloride, oral administra...

Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

This study involves review and analysis of disease activity in patients with rheumatoid arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.

Vedolizumab Study With Inflammatory Bowel Disease Patients in Germany

This study on biologics (Vedolizumab/anti-TNF) in the treatment of inflammatory bowel disease (IBD) patients in Germany extends the prospective documentation of efficacy in induction and maintenance therapy of anti-TNF to the use of Vedolizumab with a particular interest in the construction of a multifactorial model to predict long-term responses and favorable disease outcome or to predict severe side effects caused by therapy with biologics. Little data are available on the ef...

A Phase 2 Study of E6011 in Subjects With Rheumatoid Arthritis Inadequately Responding to Biologics

This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparison study in rheumatoid arthritis participants inadequately responding to biologics.

A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)

This retrospective cohort study will analyze data from multiple large U.S. health insurance claims databases to compare use of tocilizumab to other biologic disease-modifying anti-rheumatic drugs (DMARDs) in real world patients with RA. Using the date of dispensing as the index date, the analysis will compute the time to first event for several cardiovascular outcomes.

XC8 in the Treatment of Patients With Bronchial Asthma

A multicenter, double-blind, randomized, parallel-group comparative Phase II clinical study to assess the efficacy and safety of different doses of XC8 vs Placebo in patients with partly controlled bronchial asthma receiving stable treatment with low doses of inhaled corticosteroids with or without long-acting beta2-agonists during 12-weeks treatment period. Study design was developed by Pharmenterprises LLS, Russia in cooperation with Eurrus Biotech GmbH, Austria and FGK Clin...

Bioequivalence Study of Linagliptin From Prevaglip 5 mg Tablets(Eva Pharma, Egypt) and Trajenta 5 mg Tablets (Boehringer Ingelheim International GmbH, Germany)

An open label randomized, single dose, two-way crossover bioequivalence study to determine the bioequivalence of Linagliptin from Prevaglip 5 mg tablets(Eva pharma for Pharmaceuticals & Medical Appliances, Egypt) and Trajenta 5 mg tablets(Boehringer Ingelheim International GmbH, Germany) after a single oral dose administration of each to healthy adults under fasting conditions

Assessing the Drug Exposure Risk of Infants Breastfed by Women With Inflammatory Bowel Disease

Breastfeeding is beneficial to both mother and baby. However, many breastfeeding women are affected by long-term health conditions and need to take medications. Sometimes, concerns about transfer of drugs to infants via breast milk lead the mothers to either avoid breastfeeding or stop their medication. Inflammatory Bowel Disease (IBD) is a chronic condition that is marked by an abnormal response of the body's immune system, and high levels of certain proteins that cause ...

Efficiency of a Nurse-led Self-management Education Intervention in Promoting Safety Knowledge and Skills of Patients With Arthritis Treated Par Biologics

Background : Inflammatory arthritis (rheumatoid arthritis (RA) or spondyloarthritis (SpA) are painful chronic diseases which impair quality of life and work capacity. Biologics are very effective and widely used therapies. However, they are known to entail risks, particularly of infections. The risk of severe infections is of 5%/patient-year with a maximum during the first six month after the initiation of the first biologic therapy. Patient education (PE) is recommended for t...

Post-marketing Use of Inflectra (Infliximab) for Standard of Care Treatment of Rheumatoid Disease Who Are Naïve to Biologics or Switched From Remicade™

To assess persistence of Inflectra in patients with Rheumatoid Disease (Rheumatoid arthritis [RA], ankylosing spondylitis [AS], and psoriatic arthritis [PsA]) who are naive to biologics or are switching over from stable Remicade to Inflectra. The main objectives of the study are: - To evaluate real-life drug persistence in RA, AS, and PsA patients who are either initiated with Inflectra™ as their first biologic, or who are switched from stable Remicade™ ...

Clinical Trial Evaluating Methotrexate + Biologic Versus Methotrexate, Salazopyrine and Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate

Approximately, 40 to 50% of patients with rheumatoid arthritis (RA), the most frequent inflammatory arthritide, are non responders to the consensual 1st line of treatment : methotrexate. In these patients, it is well demonstrated that the addition of other immunomodulatory drug(s) often results in a significant improvement. However, the best option regarding the drug(s) to add remains unclear. Rheumatologists are currently used to adding a targeted biologic therapy, such as ant...

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Positron Emission Tomography in Rheumatoid Arthritis With Adalimumab (PETRA)

Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha). Identification of RA patients who respond to biologics is a challenging goal to avoid unnecessarily, costly and potentially harmful treatment. The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of the clinical response in RA with TNF-alpha blocking agent. Eight pa...

User Performance Evaluation of Contour® Plus One, Accu-Chek® Performa Connect, FreeStyle Optium Neo and OneTouch® Select Plus Blood Glucose Monitoring Systems Following ISO 15197:2013; EN ISO 15197:2015

The user performance evaluation shows whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system. In this study, user performance evaluation will be performed for Contour Plus One (Ascensia Diabetes Care GmbH), Accu-Chek Performa Connect (Roche Diabetes Care GmbH), FreeStyle Optium Neo (Abbott Diabetes Care Inc.), OneTouch Select Plus (LifeScan Europe) based on ISO 15197:2013; EN ISO 15197:2015, clause 8. For each ...

Biomarkers in Chronic Arthritis

Use of genotyping for the optimization of treatment with biologics in chronic arthritis by looking for an association between certain alleles and response to treatment.

Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders

Rheumatoid arthritis (RA) is the most common inflammatory rheumatoid disease in France, affecting 0.3% of the general population. Without effective treatment, the persistent inflammation causes invalidating pain and joint destruction, leading to major functional disability. Biological agents have been proposed for patients with RA who have the most severe form of the disease and that are inadequate responder patients to conventional synthetic Disease-modifying antirheuma...

Telemedical Examination of a Three-Component Oculomotor Testing Battery

The study investigates the feasibility and safety of the telemedical implementation of three diagnostic oculomotor tests using a video-oculography device and an extended teleconferencing system. The testing battery comprises Halmagyi's head impulse test, test for nystagmus and test of skew (vertical misalignment) known as the HINTS protocol. Previously published data have shown high sensitivity and specificity of the protocol for the discrimination of central and peripheral cau...

Compliance After Orthodontic Treatment Using Thermoplastic or Hawley Retainers

This study aims to assess adolescent's compliance after the end of orthodontic treatment using either thermoplastic or Hawley retainers in the upper arch, with the aid of TheraMon microsensor (MC Technology GmbH).

A Study to Observe the Safety and Efficacy of Vedolizumab in Biologically Naive Participants Wtih Ulcerative Colitis (UC) or Crohn´s Disease (CD)

The purpose of this non-interventional study (NIS) study is to assess further knowledge on the routine use of Entyvio in inflammatory bowel disease therapy, particularly the use in participants with CD and UC naive to biologics.

Influence of Non-invasive Neurostimulation (Transcutaneous Vagus Nerve Stimulation) on 1. the Noradrenergic Release in the Brain and 2. a Neuropsychological Memory Task

The goal of this study is to investigate the influence of transcutaneous vagus nerve stimulation 1. on the noradrenergic system in the brain and 2. on memory, in healthy volunteers. Preclinical and clinical studies indicate that noradrenaline plays a role in the working mechanism of vagus nerve stimulation. This study will investigate if the effects of invasive vagus nerve stimulation can be replicated with transcutaneous vagus nerve stimulation. The release of noradren...

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