AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
26. oktober 2017 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
286
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Los Angeles, California, Forente stater, 90095
- 100 UCLA Medical Plaza, Suite 305
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Palo Alto, California, Forente stater, 94304
- Hand Surgery Clinic
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Colorado
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Denver, Colorado, Forente stater, 80210
- Hand Surgery Associates, PC
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Georgia
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Atlanta, Georgia, Forente stater, 30342
- The Hand and Upper Extremity Center of Georgia, P.C.
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Illinois
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Rockford, Illinois, Forente stater, 61107
- Rockford Orthopedic Associates, Ltd.
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Indiana
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Indianapolis, Indiana, Forente stater, 46260
- The Indiana Hand Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital, Department of Orthopedic Surgery
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Newton, Massachusetts, Forente stater, 02462
- Newton-Wellesley Hospital
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55431
- TRIA Orthopaedic Center
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New York
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New York, New York, Forente stater, 10021
- Hospital for Special Surgery
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Stony Brook, New York, Forente stater, 11794
- SUNY Stony Brook - Department of Orthopedics
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73109
- Health Research Institute
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Pennsylvania
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Erie, Pennsylvania, Forente stater, 16550
- Hand Microsurgery & Reconstructive Orthopaedics
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State College, Pennsylvania, Forente stater, 16801
- University Orthopedics Center
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Rhode Island
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Providence, Rhode Island, Forente stater, 02905
- Department of Orthopaedics, Brown University, Rhode Island Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Reduction in Contracture to 5° or Less
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Clinical Improvement After the Last Injection
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline, Day 30 after first 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 first injection
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Veronica Urdaneta, MD, Endo Pharmaceuticals
Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. desember 2007
Primær fullføring (Faktiske)
1. november 2008
Studiet fullført (Faktiske)
1. november 2008
Datoer for studieregistrering
Først innsendt
11. september 2007
Først innsendt som oppfylte QC-kriteriene
11. september 2007
Først lagt ut (Anslag)
12. september 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
2. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
26. oktober 2017
Sist bekreftet
1. oktober 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AUX-CC-858
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