AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
26 oktober 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
286
Fase
- Fase 3
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90095
- 100 UCLA Medical Plaza, Suite 305
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Palo Alto, California, Verenigde Staten, 94304
- Hand Surgery Clinic
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Colorado
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Denver, Colorado, Verenigde Staten, 80210
- Hand Surgery Associates, PC
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Georgia
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Atlanta, Georgia, Verenigde Staten, 30342
- The Hand and Upper Extremity Center of Georgia, P.C.
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Illinois
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Rockford, Illinois, Verenigde Staten, 61107
- Rockford Orthopedic Associates, Ltd.
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46260
- The Indiana Hand Center
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Massachusetts
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Boston, Massachusetts, Verenigde Staten, 02115
- Brigham and Women's Hospital, Department of Orthopedic Surgery
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Newton, Massachusetts, Verenigde Staten, 02462
- Newton-Wellesley Hospital
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55431
- TRIA Orthopaedic Center
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New York
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New York, New York, Verenigde Staten, 10021
- Hospital for Special Surgery
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Stony Brook, New York, Verenigde Staten, 11794
- SUNY Stony Brook - Department of Orthopedics
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Oklahoma
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Oklahoma City, Oklahoma, Verenigde Staten, 73109
- Health Research Institute
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Pennsylvania
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Erie, Pennsylvania, Verenigde Staten, 16550
- Hand Microsurgery & Reconstructive Orthopaedics
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State College, Pennsylvania, Verenigde Staten, 16801
- University Orthopedics Center
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Rhode Island
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Providence, Rhode Island, Verenigde Staten, 02905
- Department of Orthopaedics, Brown University, Rhode Island Hospital
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: AA4500 0,58 mg
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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.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Reduction in Contracture to 5° or Less
Tijdsspanne: Within 30 days after last injection
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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.
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Within 30 days after last injection
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Clinical Improvement After the Last Injection
Tijdsspanne: Baseline, within 30 days after last injection
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Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
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Baseline, within 30 days after last injection
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Percent Reduction From Baseline Contracture After the Last Injection
Tijdsspanne: Baseline, Day 30 after last injection
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Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
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Baseline, Day 30 after last injection
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Change From Baseline Range of Motion After the Last Injection
Tijdsspanne: Baseline, Day 30 after last injection
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Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
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Baseline, Day 30 after last injection
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Time to Reach Clinical Success
Tijdsspanne: Within 30 days after last injection
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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
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Within 30 days after last injection
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Clinical Success After the First Injection
Tijdsspanne: Within 30 days after first injection
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Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
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Within 30 days after first injection
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Clinical Improvement After the First Injection
Tijdsspanne: Baseline, within 30 days after first injection
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Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
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Baseline, within 30 days after first injection
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Percent Reduction From Baseline Contracture After the First Injection
Tijdsspanne: Baseline, Day 30 after first injection
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Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
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Baseline, Day 30 after first injection
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Change From Baseline Range of Motion After the First Injection
Tijdsspanne: 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
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Veronica Urdaneta, MD, Endo Pharmaceuticals
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 december 2007
Primaire voltooiing (Werkelijk)
1 november 2008
Studie voltooiing (Werkelijk)
1 november 2008
Studieregistratiedata
Eerst ingediend
11 september 2007
Eerst ingediend dat voldeed aan de QC-criteria
11 september 2007
Eerst geplaatst (Schatting)
12 september 2007
Updates van studierecords
Laatste update geplaatst (Werkelijk)
2 december 2017
Laatste update ingediend die voldeed aan QC-criteria
26 oktober 2017
Laatst geverifieerd
1 oktober 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AUX-CC-858
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