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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.

Game Ready continuous-flow cryo- and cyclic compression therapy after fracture treament of the hip: a prospective multicenter, open-label, multicenter, randomized, controlled, clinical trial on postoperative effects on pain.

The goal of the study is whether to establish if application of combined cyrocompression therapy directly postoperative after hip fracture surgery results in a significant reduction in painperception en whether this reduces the morfine consumption.…

A multi-center, uncontrolled extension study evaluating efficacy and safety of SAR153191 on top of DMARDs in patients with active Rheumatoid Arthritis (RA)

To document the long term safety and efficacy of sarilumab added to DMARDs.

An extension study to evaluate the sustainability of clinical benefits, safety and tolerability of secukinumab in patients with active Ankylosing Spondylitis (CAIN457F2305E1)

Primary: To evaluate the sustainability of subject benefits as quantified by the ASAS20 during long-term treatment.Secondary: ASAS40, safety and tolerability.

Effectiveness of ultrasound imaging in general practice: optimising the management of patients with non-chronic shoulder complaints.

To optimize the management of non-chronic shoulder pain in primary care by the introduction of ultrasound as a diagnostic triage tool. The following research questions will be addressed:1. What are the effects of diagnostic ultrasound and its…

Safety and Efficacy of BI 695500 in patients with moderately to severely active rheumatoid arthritis: an open-label extension trial

Primary objective:To evaluate the long-term safety of BI 695500 in adult patients with moderate tosevere active rheumatoid arthritis (RA) who have successfully completed treatment inTrial 1301.1.Secondary objective:* To assess the long-term efficacy…

Joint distraction (KJD) in treatment of knee osteoarthritis: cartilage changes in a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

1. To compare cartilage changes after KJD and after HTO, based on MRI, radiographs and biomarkers, evaluated 2 years post treatment. 2. To compare clinical efficacy after KJD and after HTO during 2 year follow-up by a questionnaire (KOOS; for pain,…

A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures

To determine the efficacy and the safety of PREOB®, a proprietary population of autologous bone-forming cells, in the treatment of non-infected hypotrophic non-union fractures of long bones.

A Clinical Study to Evaluate the Safety and Effectiveness of NOVOCART® 3D plus Compared to Microfracture in the Treatment of Articular Cartilage Defects of the Knee

Primary ObjectiveTo demonstrate that the effectiveness of the NOVOCART® 3D plus autologouschondrocyte transplantation system is superior to microfracture for the treatment ofarticular cartilage defects of the knee by demonstrating superiority of the…

An Extension Protocol for Participants of Genzyme-Sponsored;Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study of Matrix-Induced Autologous Chondrocyte Implantation (MACI® implant) for the Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle Including the Trochlea

The objective of this study is to examine the 5-year efficacy and safety of Matrix-Induced Autologous Chondrocyte Implantation (MACI® Implant), compared with arthroscopic microfracture, in patients who received study treatment in Genzyme-sponsored…

An open-label study assessing the addition of subcutaneous golimumab (GLM) to conventional disease-modifying antirheumatic drug (DMARD) therapy in biologic-naïve subjects with rheumatoid arthritis (Part 1), followed by a randomized study assessing the value of combined intravenous and subcutaneous GLM administration aimed at inducing and maintaining remission (Part 2).

Part 1: To assess the safety and effectiveness of subcutaneous golimumab 50 mg (SC-GLM50), administered by autoinjection once monthly during 6 months, when combined with different DMARD regimens used in daily rheumatology. Part 2: In subjects who…

Joint distraction in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: total knee prosthesis

Primary:- To test the hypothesis that the clinical effect of KJD (determined by WOMAC) is not (clinically relevant) different from TKP at 2 years post treatment (equivalence hypothesis). Secondary:- To describe and compare the clinical efficacy over…

A Randomized Open-Label Study to Evaluate the Safety and Efficacy of Denosumab and Monthly Actonel® Therapies in Postmenopausal Women Transitioned from Weekly or Daily Alendronate Therapy

The primary objective of the study is to evaluate the effect of denosumab 60mg every 6 months (Q6M) compared with Actonel 150mg monthly (QM) on total hip Bone Mineral Density (BMD) at 12 months in postmenopausal women transitioning from previous…

AN OPEN LABEL EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF ETANERCEPT IN CHILDREN AND ADOLESCENTS WITH EXTENDED OLIGOARTICULAR JUVENILE IDIOPATHIC ARTHRITIS, ENTHESITIS RELATED ARTHRITIS, OR PSORIATIC ARTHRITIS WHO WERE PREVIOUSLY ENROLLED IN PROTOCOL 0881A1 3338 WW(B1801014)

Primary* To monitor the occurrence of malignancy in pediatric subjects with extended oligoarticular JIA, ERA, or PsA.Secondary* To assess the long-term safety profile of etanercept.

Abduction brace versus sling after arthroscopic cuff repair

Primary Objective: Is there reduction in pain using an abduction brace in patients undergoing arthroscopic cuff repair? Secondary Objectives: - Are there differences in function and recovery of the cuff, determined using questionnaires and echo?- Is…

A Prospective, Randomized, Open-Label, Parallel-Group, Multicenter Study
to Demonstrate the Superiority of Matrix-induced Autologous Chondrocyte Implantation (MACI® Implant) versus Arthroscopic Microfracture for the
Treatment of Symptomatic Articular Cartilage Defects of the Femoral Condyle including the Trochlea.

The objective of this study is to demonstrate superior efficacy and evaluate the safety of MACI Implant compared with arthroscopic microfracture in the treatment of patients (aged 18 to 55 years old) with symptomatic articular cartilage defects of…

A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures.

To determine the efficacy and the safety of PREOB, a proprietary population of autologous bone-forming cells, in the treatment of non-infected hypotrophic non-union fractures of long bones.

MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS

To evaluate the safety and tolerability of SC TCZ monotherapy and/or in combination with MTX or other non-biologic DMARDs comprising AEs, physical examination, vital signs, and clinical laboratory assessments, including immunogenicity, in patients…

An open-label extension study of CACZ885H2357E1 on the treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective

Primary: Long term safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.

Joint distraction (KJD) in treatment of knee osteoarthritis: a comparison with a presently applied surgical alternative: high tibial osteotomy (HTO)

1. To compare cartilage repair between KJD and HTO, evaluated 2 years post treatment. The hypothesis is that KJD results in (more) cartilage repair compared to HTO. 2. To compare cartilage tissue repair over 2 year follow-up compared to baseline and…