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A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis

PrimaryThe primary objective is to compare both ixekizumab regimens (80 mg every 2 weeks [Q2W] or 80 mg every 4 weeks [Q4W]) versus placebo in patients with active radiographic axial spondyloarthritis (rad-axSpA) at Week 16.SecondaryThe major…

Wrist repair in severe trauma (WRIST) study

The objective of this study is to investigate whether reconstruction of the radiocarpal joint by implantation of a tailor-made and patient specific 3D printed interpositional arthroplasty made out of Bionate® II 80A PCU (DSM®) is feasible as a…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects with Moderately to Severely Active Rheumatoid Arthritis with Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 30 mg (QD) and 15 mg QD versus placebo on a background of csDMARD(s) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-…

A multi center, multi national, open label, extension study to evaluate the long-term efficacy and safety of BMN 044 (PRO044) in subjects with Duchenne muscular dystrophy

The aim of this study is to provide continuing access to BMN 044 treatment for subjects previously treated with the study drug. The information gained from this study is expected to further characterize the efficacy and safety of BMN 044 over a…

A Phase 3, Randomized, Double-Blind Study Comparing ABT-494 Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Period 1: The first objective, of period 1, is to compare the safety and efficacy of ABT-494 15 mg QD monotherapy, and 30 mg QD monotherapy versus weekly methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis…

An open-label extension study of the long-term safety, tolerability and efficacy of drisapersen in subjects with Duchenne Muscular Dystrophy.

The purpose of this study is to assess the safety, tolerability and efficacy of long term drisapersen in subjects with DMD.

A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

The primary objective in the glucocorticoid-continuing subpopulation of men and women treated with chronic glucocorticoid therapy (>= 7.5 mg daily prednisone or its equivalent for >= 3 months and are planning to continue treatment for…

Sports-related Long-term outcomes of Overuse of the Wrist

The aim of this study is to evaluate the long-term imaging and functional outcomes of overuse injuries of the wrist in (former) athletes.

Gait retraining by real-time feedback in patients with knee osteoarthritis
(KneeMo Feedback Study )

A) To evaluate the use of real-time visual and audio feedback on the knee adduction moment and on kinematic patterns during gait in patients with knee osteoarthritis to decrease the biomechanical load on the knee via implicit learning and explicit…

An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity, and Systemic Exposure of ATYR1940 in Adult Patients with Facioscapulohumeral Muscular Dystrophy (FSHD)

The objectives of this study are to:• Evaluate the safety, tolerability, and immunogenicity of long-term treatment with intravenous (IV) ATYR1940 in adult patients with facioscapulohumeral muscular dystrophy (FSHD) previously enrolled in clinical…

A phase IIb, open-label study to assess the efficacy, safety, pharmacodynamics and pharmacokinetics of multiple subcutaneous doses of BMN 045 (previously known as PRO045) in subjects with Duchenne muscular dystrophy

Primary objective:To assess the efficacy of BMN 045 after 48 weeks treatment in ambulant subjects with Duchenne muscular dystrophy.Secondary objectives:To assess the safety and tolerability of BMN 045 after 48 weeks of treatment in all study…

Cervical radicular pain: A randomised controlled trial comparing percutaneous plasma discectomy and anterior cervical discectomy.

The aim of this study is to compare the effects of anterior cervical discectomy versus percutaneous plasma discectomy on pain, on global perceived effect, functional status and health-related quality of life in a group of patients with cervical…

Volar Internal Plate Fixation versus Plaster in Extra-articular distal Radial fractures (VIPER)

To compare the functional outcome of ORIF with a volar locking plate to closed reduction and plaster immobilisation in patients with dislocated extra-articular distal radius fractures.

Ammendment of protocol: Intravenous iron treatment in iron deficient patients with idiopathic pulmonary arterial hypertension. Title amendment: Skeletal muscle strength in healthy persons and patients with pulmonary hypertension

To evaluate the effects of intravenous iron suppletion in iron deficient PAH patients.Amendment: to compare exercise capacity and isolated muscle strength in IPAH patients and healthy controls

PRevention of knee Osteoarthritis in Overweight Females (PROOF); long-term follow-up

The aim of the current project is to evaluate the long-term effects of a) a pragmatic lifestyle intervention aimed at weight loss and b) a 30-month placebo-controlled intervention with glucosamine sulphate on the development of knee osteoarthritis…

Undercarboxylated osteocalcin, the hypothalamic-pituitary-gonadal axis and glucose metabolism in male patients with osteoporosis.

The objective of the study is to study the effect of Teripratide (rhPTH 1-34) on undercarboxylated osteocalcin levels, testosterone concentrations, glucose tolerance and insulin sensitivity in male subjects with primary osteoporosis.

Treatment of the Medial Meniscus with the NUsurface® Meniscus Implant.
A Prospective, Multi-Center, Open Label, Non-randomized Study of the NUsurface® Meniscus Implant

To evaluate the safety, device-related complications, and performance of the NUsurface® meniscus implant as a device for the treatment of patients with degenerative and/or tears of the medial meniscus. .

Prospective evaluation of bone strength, physical activity, falls, subsequent fractures and mortality in patients presenting with a recent clinical fracture.

The primary objective is to assess bone structure parameters and bone strength by high resolution peripheral quantitative CT evaluation (HRpQCT) and physical activity in relation with subsequent falls, fractures and mortality in patients with a…

Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy in older Patients. A Randomized Controlled Trial.

The objective of this study is to evaluate the effectiveness and cost-effectiveness of surgical and conservative treatment of non-obstructive meniscal injuries in older patientsHypothesis: We assume equal improvement of physical function in both…

A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52 weeks on physical function, muscle strength, and mobility and additional long-term safety up to 2 years in patients with sporadic inclusion body myositis (CBYM338B2203)

Primary: to demonstrate that at least one dose regimen of BYM338 in sporadic inclusion body myositis patients will increase the distance traveled as measured by change from baseline at Week 52 of the 6 minute walking distance test relative to…