Kusajili – Centralise les essais cliniques mondiaux

Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis To assess the efficacy of two different treatment regimens of etanercept in psoriasis subjects with psoriatic arthritis with respect to both the skin and joint manifestations.

• Pays Argentina, Australia, Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Saudi Arabia, Serbia, Spain, Sweden, Switzerland, Taiwan, Province of China, Turkey, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.

• Pays Austria, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain,
• Organes Aucun
• Spécialités Aucun

Study Evaluating Etanercept for the Treatment of Active, Severe, and Advanced Axial Ankylosing Spondylitis Evaluation of the efficacy and safety of etanercept (Enbrel) in patients with active, severe and advanced ankylosing spondylitis.

• Pays France, Germany, Hungary, Netherlands,
• Organes Aucun
• Spécialités Aucun

Study Evaluating the Effect of Lecozotan SR on the QTc Interval This is a randomized, double-blind, placebo- and moxifloxacin (open-label)-controlled, 4-period crossover study.

• Pays France,
• Organes Aucun
• Spécialités Aucun

Study Evaluating the Safety of Lecozotan SR in Healthy Young and Elderly Subjects To assess the safety, tolerability and pharmacokinetics of single and multiple ascending oral doses of lecozotan SR in healthy young and elderly subjects.

• Pays France,
• Organes Aucun
• Spécialités Aucun

Study Evaluating rhBMP-2/CPM in Closed Distal Radius Fractures To evaluate the safety of rhBMP-2/CPM administered to subjects presenting with closed distal radius fractures. The key safety variables comprising this assessment are: 1) incidence of delayed union; 2) median time to fracture union (assessed by the investigators); 3) incidence of local neurovascular events (those involving the region under study [RUS]); and 4) rate of fracture displacement. The primary objective will be met if these outcomes in the active and placebo treatment groups are at least comparable to those of the SOC control group.

• Pays Finland, France,
• Organes Aucun
• Spécialités Aucun

Study Evaluating InductOs in Diaphyseal Tibia Fractures Demonstrate a larger proportion of subjects with healed fractures among subjects treated with InductOs and reamed, locked intramedullary nailing compared to subjects treated with reamed, locked intramedullary nailing alone.

• Pays Belgium, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Romania, South Africa, Spain, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine pediatric vaccines in France.

• Pays France,
• Organes Aucun
• Spécialités Aucun

Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

• Pays Belgium, Croatia, Czech Republic, Finland, France, Hungary, Mexico, Netherlands, Poland, Romania, South Africa, Spain, Sweden, Ukraine, United Kingdom,
• Organes Aucun
• Spécialités Aucun

Prospective Registry of European Hemophilia B Patients Receiving BeneFIX® for Usual Use This is an open-label multi-center Registry in patients with hemophilia B receiving BeneFIX. All patients who begin treatment with BeneFIX in European Union countries, will be eligible for participation. Patient demographics will be collected at baseline for all patients. A baseline FIX activity and Bethesda assay for inhibitor based on historical data should be recorded if available. Adverse events as defined in the protocol will also be reported on the appropriate forms. Data will be collected from patients on an ongoing basis to ensure that information is being captured for each patient being treated with BeneFIX.

• Pays Austria, Belgium, France, Germany, Italy, Netherlands, Portugal, Spain, Sweden, United Kingdom,
• Organes Aucun
• Spécialités Aucun