AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
26 octobre 2017 mis à jour par: Endo Pharmaceuticals
A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Study AUX-CC-858 was an open-label continuation of the double-blind Study AUX-CC-857 (NCT00528606). Subjects who complete the Day 90 visit after their initial injection in Study AUX-CC-857 (NCT00528606) entered into Study AUX-CC-858. Subjects who required further treatment in Study AUX-CC-858, either because their treated metacarpophalangeal and/or proximal interphalangeal (PIP) joints did not have a reduction in contracture to 5° or less, the cord affecting that joint received less than three injections of AA4500, or they had other eligible cords that received no treatment in AUX-CC-857 (NCT00528606), had the option to receive up to five injections of AA4500 in this extension study. Subjects requiring further treatment were followed for efficacy and safety on Days 1, 7, and 30 after each injection, with injections separated by four weeks. Follow-up visits for the determination of efficacy and safety were conducted on Day 90, Month 6, and Month 9.
This study was designed to be part of the larger clinical program, for adult patients with Dupuytren's contracture with a palpable cord, where the data from 2 pivotal Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7 non-pivotal studies were evaluated.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
286
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Los Angeles, California, États-Unis, 90095
- 100 UCLA Medical Plaza, Suite 305
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Palo Alto, California, États-Unis, 94304
- Hand Surgery Clinic
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Colorado
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Denver, Colorado, États-Unis, 80210
- Hand Surgery Associates, PC
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Georgia
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Atlanta, Georgia, États-Unis, 30342
- The Hand and Upper Extremity Center of Georgia, P.C.
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Illinois
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Rockford, Illinois, États-Unis, 61107
- Rockford Orthopedic Associates, Ltd.
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Indiana
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Indianapolis, Indiana, États-Unis, 46260
- The Indiana Hand Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Brigham and Women's Hospital, Department of Orthopedic Surgery
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Newton, Massachusetts, États-Unis, 02462
- Newton-Wellesley Hospital
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55431
- TRIA Orthopaedic Center
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New York
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New York, New York, États-Unis, 10021
- Hospital for Special Surgery
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Stony Brook, New York, États-Unis, 11794
- SUNY Stony Brook - Department of Orthopedics
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Oklahoma
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Oklahoma City, Oklahoma, États-Unis, 73109
- Health Research Institute
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Pennsylvania
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Erie, Pennsylvania, États-Unis, 16550
- Hand Microsurgery & Reconstructive Orthopaedics
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State College, Pennsylvania, États-Unis, 16801
- University Orthopedics Center
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Rhode Island
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Providence, Rhode Island, États-Unis, 02905
- Department of Orthopaedics, Brown University, Rhode Island Hospital
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
- Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
- Were naïve to AA4500 treatment or had received only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
- Were judged to be in good health.
- Must have participated in protocol AUX-CC-857 (NCT00528606).
Exclusion Criteria:
- Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
- Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
- Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: AA4500 0,58 mg
|
Subjects may have received up to five injections of AA4500 0.58 mg into the cords of the affected hand, with each injection separated by at least 30 days.
Individual cords may have received up to a maximum of three AA4500 injections.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Reduction in Contracture to 5° or Less
Délai: Within 30 days after last injection
|
Successfully treated or clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
|
Within 30 days after last injection
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Clinical Improvement After the Last Injection
Délai: Baseline, within 30 days after last injection
|
Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
|
Baseline, within 30 days after last injection
|
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Percent Reduction From Baseline Contracture After the Last Injection
Délai: Baseline, Day 30 after last injection
|
Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
|
Baseline, Day 30 after last injection
|
|
Change From Baseline Range of Motion After the Last Injection
Délai: Baseline, Day 30 after last injection
|
Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
|
Baseline, Day 30 after last injection
|
|
Time to Reach Clinical Success
Délai: Within 30 days after last injection
|
Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection, displayed in post injection time point categories
|
Within 30 days after last injection
|
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Clinical Success After the First Injection
Délai: Within 30 days after first injection
|
Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
|
Within 30 days after first injection
|
|
Clinical Improvement After the First Injection
Délai: Baseline, within 30 days after first injection
|
Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
|
Baseline, within 30 days after first injection
|
|
Percent Reduction From Baseline Contracture After the First Injection
Délai: Baseline, Day 30 after first injection
|
Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
|
Baseline, Day 30 after first injection
|
|
Change From Baseline Range of Motion After the First Injection
Délai: Baseline, Day 30 after first injection
|
Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
|
Baseline, Day 30 after first injection
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Directeur d'études: Veronica Urdaneta, MD, Endo Pharmaceuticals
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Liens utiles
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 décembre 2007
Achèvement primaire (Réel)
1 novembre 2008
Achèvement de l'étude (Réel)
1 novembre 2008
Dates d'inscription aux études
Première soumission
11 septembre 2007
Première soumission répondant aux critères de contrôle qualité
11 septembre 2007
Première publication (Estimation)
12 septembre 2007
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
2 décembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
26 octobre 2017
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AUX-CC-858
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .