Tableau I.
Liste des essais industriels et académiques en cours à la plateforme I-Motion Adultes. Abréviations : AFM : Association Française contre les myopathies, AIM : Association Institut de Myologie, APHP : Assistance Publique Hôpitaux de Paris, APHM : Assistance Publique Hôpitaux de Marseille, DMB : Becker Muscular Dystrophy, CMT : Charcot-Marie-Tooth, DMD : Duchenne Muscular Dystrophy, DM : Dermatomyositis, LGMD : Limb-Girdle Muscular Dystrophy, MG : myasthenia gravis, RIPH : Recherche impliquant la personne humaine, SMA : Spinal Muscular Atrophy.
| Acronyme | Titre | Promoteur | Maladie | Nb de patients inclus | Inclusions en cours | RIPH |
|---|---|---|---|---|---|---|
| Essais industriels | ||||||
| GNT-015-FKRP | Prospective longitudinal study of the natural history and functional status of patients with LGMD 2I | Généthon | LGMD 2I | 15 | Oui | RIPH2 |
| IgPro20 | A Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 (Subcutaneous Ig) in Dermatomyositis | CSL Behring | DM | 0 | Oui | RIPH1 |
| UBC MG0003 | A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of Rozanolixizumab in adult patients with generalized myasthenia gravis. | UCB Pharma | MG | 6 | Non | RIPH1 |
| UBC MG0004 | A randomized, open-label extension study to investigate the long term safety, tollerability and efficacy of Rozanolixizumab in adult patients with generalized myasthenia gravis. | UCB Pharma | MG | 5 | Non | RIPH1 |
| UBC MG0007 | A Phase 3, open-label extension (OLE) study to evaluate 6-week treatment cycles of Rozanolixizumab in study participants with gMG. | UCB Pharma | MG | 5 | Non | RIPH1 |
| CLN-PXT3003-06 (PREMIER) | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Assess the Efficacy, Safety, and Tolerability of PXT3003 in Charcot-Marie-Tooth type 1A (CMT1A) | Pharnext | CMT 1A | 3 | Oui | RIPH1 |
| Essais académiques | ||||||
| JAIN_COS_2 | An International Clinical Outcome Study of dysferlinopathy | AIM | LGMD 2B | 7 | Oui | RIPH2 |
| Registre Français SMA | French Register of Patients With Spinal Muscular Atrophy (SMA) | APHP | SMA | 35 | Oui | RIPH3 |
| SMAPAR | Consequences of a progressive genetic disease, spinal muscular atrophy, on the representations of parenthood and parental overload | AIM | SMA | 60 | Oui | RIPH2 |
| Registre Français des Dystrophinopathies | Registre Français des Dystrophinopathies | AFM-Téléthon | DMD et DMB | 3 | Oui | RIPH3 |
| SMOB | Natural History Of Spinal Muscular Atrophy type III and IV: Outcome measures and Biomarkers | APHM | SMA type III et IV | 1 | Oui | RIPH2 |
| STRONG | Mesure de l’expression de la protéine GDF5 dans des biopsies musculaires et le sérum de sujets sains jeunes et âgés | AIM | Sarcopénie | 0 | Oui | RIPH2 |
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