AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
26 oktober 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
286
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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California
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Los Angeles, California, Förenta staterna, 90095
- 100 UCLA Medical Plaza, Suite 305
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Palo Alto, California, Förenta staterna, 94304
- Hand Surgery Clinic
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Colorado
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Denver, Colorado, Förenta staterna, 80210
- Hand Surgery Associates, PC
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Georgia
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Atlanta, Georgia, Förenta staterna, 30342
- The Hand and Upper Extremity Center of Georgia, P.C.
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Illinois
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Rockford, Illinois, Förenta staterna, 61107
- Rockford Orthopedic Associates, Ltd.
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46260
- The Indiana Hand Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02115
- Brigham and Women's Hospital, Department of Orthopedic Surgery
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Newton, Massachusetts, Förenta staterna, 02462
- Newton-Wellesley Hospital
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55431
- TRIA Orthopaedic Center
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-
New York
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New York, New York, Förenta staterna, 10021
- Hospital for Special Surgery
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Stony Brook, New York, Förenta staterna, 11794
- SUNY Stony Brook - Department of Orthopedics
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Oklahoma
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Oklahoma City, Oklahoma, Förenta staterna, 73109
- Health Research Institute
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Pennsylvania
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Erie, Pennsylvania, Förenta staterna, 16550
- Hand Microsurgery & Reconstructive Orthopaedics
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State College, Pennsylvania, Förenta staterna, 16801
- University Orthopedics Center
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Rhode Island
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Providence, Rhode Island, Förenta staterna, 02905
- Department of Orthopaedics, Brown University, Rhode Island Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Reduction in Contracture to 5° or Less
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Clinical Improvement After the Last Injection
Tidsram: 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
|
|
Percent Reduction From Baseline Contracture After the Last Injection
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
|
Clinical Success After the First Injection
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Studierektor: Veronica Urdaneta, MD, Endo Pharmaceuticals
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 december 2007
Primärt slutförande (Faktisk)
1 november 2008
Avslutad studie (Faktisk)
1 november 2008
Studieregistreringsdatum
Först inskickad
11 september 2007
Först inskickad som uppfyllde QC-kriterierna
11 september 2007
Första postat (Uppskatta)
12 september 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
2 december 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
26 oktober 2017
Senast verifierad
1 oktober 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AUX-CC-858
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .