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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.

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.

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…

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…

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.

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.

A Phase III Open-Label, Single-Group, Extension Study to
Obtain Long-Term Safety and Tolerability Data of
Idebenone in the Treatment of Friedreich*s Ataxia Patients

- To gather long-term data on the safety and tolerability of idebenone inFriedreich*s Ataxia- To explore the effect of idebenone after longer term administration onneurological symptoms and signs as assessed by the InternationalCooperative Ataxia…

An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety and Sustained Efficacy of Denosumab (AMG162) in the Treatment of Postmenopausal Osteoporosis

To describe the safety and tolerability of up to 5 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab.

A Phase III Open Label Extension Study to Assess the Long-Term Safety
and Efficacy of Idebenone in Patients with Duchenne Muscular Dystrophy
(DMD) who completed the SIDEROS study

Primary:* To assess the long-term safety of idebenone in DMD patients who completed the SIDEROS study.Secondary:* To describe the long-term evolution of respiratory function in idebenone-treated DMD patients who completed the SIDEROS study,…

A Phase 3, Multi-center, Open-label Extension Study to Assess the Safety and Efficacy of Viltolarsen in Ambulant Boys with Duchenne Muscular Dystrophy (DMD)

This study has been transitioned to CTIS with ID 2023-507146-91-00 check the CTIS register for the current data. Primary Objective:• To evaluate the safety and tolerability of viltolarsen administered intravenously (IV) at weekly doses of 80 mg/kg…

A Multicenter, Double-blind, Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Subjects with Rheumatoid Arthritis

The primary objective of this study is:* To evaluate the long-term safety and tolerability of filgotinib in subjects who have completed one of the parent studies of filgotinib in RA.The secondary objectives of this study are:* To evaluate the long-…

Tamoxifen in Duchenne muscular dystrophy - TAMDMD:
A multicentre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy 48-week trial
The study will be extended to an open label study with the following title (OLE: Open Label Extension):
Tamoxifen in Duchenne muscular dystrophy - TAMDMD:
A 48 week open label extension of a multi centre, randomised, double-blind, placebo-controlled, phase 3 safety and efficacy trial

To test if tamoxifen treatment, compared to placebo, reduces the progression of the disease in 6.5-12 years old ambulant DMD patients by at least 50% (using the MFM D1 subscore as primary clinical endpoint in group A patients).To test if tamoxifen…

A LONG-TERM, OPEN-LABEL FOLLOW-UP STUDY OF TOFACITINIB FOR TREATMENT OF JUVENILE IDIOPATHIC ARTHRITIS (JIA)

Primary* The primary objective of this study is to determine the long term safety and tolerability of tofacitinib for treatment of the signs and symptoms of JIA.Secondary* The secondary objective of this study is to evaluate the persistence of…

Results of the Anser Clavicle Pin for treatment of Midshaft Clavicle Fractures

The goals of this study are to evaluate the union rate, patient satisfaction and functional results of the Anser Clavicle Pin in a larger cohort then approved in the study, Anser; A novel intramedullary device for fixation of midshaft clavicle…

Open label, long-term safety, tolerability, and efficacy study of GIVINOSTAT in all DMD patients who have been previously treated in one of the GIVINOSTAT studies.

This study has been transitioned to CTIS with ID 2023-504520-26-00 check the CTIS register for the current data. Primary objective:To assess the long term safety and tolerability of GIVINOSTAT in patients with DMD following core protocols program…

Induction of Cure in Early Arthritis. A single blind randomized clinical trial.

Primary Objectives: * to establish - which is the best treatment, MTX or baricitinib, to ensure rapid symptom relief of recent onset UA, based on clinical and patient reported outcomes from baseline to 3 months. Secondary Objective: * to establish…

A Multicenter, Randomized, Dose-Blind, Phase 3 Long-Term Extension
Study to Evaluate Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adult Participants with Active Systemic Lupus Erythematosus.

This study has been transitioned to CTIS with ID 2023-505635-13-00 check the CTIS register for the current data. The Primary Objective of this Clinical Trial is to evaluate the long-term safety and tolerability of litifilimab in participants with…