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The purpose of study AUX-CC-860 is to assess the durability of response of the AA4500 treatment regimen. This study will also evaluate long-term safety and progression of disease in joints.
Phase 3 non-treatment study in which Year 2 to Year 5 year follow-up of subjects who received AA4500 in the 9-month open-label studies (AUX-CC-854 and AUX-CC-856) or the 12-month double-blind with open-label extension studies (AUX-CC-857/AUX-CC-858 and AUX-CC-859). After completion of one of the above mentioned studies, subjects are enrolled and followed once a calendar year for 4 consecutive years with at least 6 months between consecutive visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follow-up | Subjects Previously Treated with AA4500 |
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| Measure | Description | Time Frame |
|---|---|---|
| Contracture Measurements | yearly |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity, concomitant medications, medical history, and adverse events | yearly |
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Inclusion Criteria:
To be eligible for this study a subject had to:
Exclusion Criteria:
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Subjects with Advanced Dupuytren's Disease Previously Treated with AA4500 in Studies AUX-CC-854, AUX-CC-856, AUX-CC-857/AUX-CC-858, and AUX-CC-859
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Urdaneta, MD | Endo Health Solutions | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Research Institute | Phoenix | Arizona | 85050 | United States | ||
| Tucson Orthopedic Institute, P.C. |
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| Label | URL |
|---|---|
| Collagenase | View source |
| Dupuytren Society | View source |
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serum
| Tucson |
| Arizona |
| 85172 |
| United States |
| Providence Clinical Research | Burbank | California | 91505 | United States |
| 100 UCLA Medical Plaza, Suite 305 | Los Angeles | California | 90024 | United States |
| Hand Surgery Clinic | Palo Alto | California | 94304 | United States |
| The Hand and Upper Extremity Center of Georgia, P.C. | Atlanta | Georgia | 30342 | United States |
| Southern Illinois Hand Center, S.C. | Effingham | Illinois | 62401 | United States |
| Rockford Orthopedic Associates, Ltd. | Rockford | Illinois | 61107 | United States |
| The Indiana Hand Center | Indianapolis | Indiana | 46260 | United States |
| Via Christi Research | Wichita | Kansas | 67214 | United States |
| Brigham and Women's Hospital, Department of Orthopedic Surgery | Boston | Massachusetts | 02115 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | United States |
| Marquette General Health System | Marquette | Michigan | 49855 | United States |
| TRIA Orthopaedic Center | Minneapolis | Minnesota | 55431 | United States |
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| SUNY Stony Brook - Department of Orthopedics | Stony Brook | New York | 11794 | United States |
| The Bone and Joint Center | Bismarck | North Dakota | 58502 | United States |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | United States |
| Hand Microsurgery & Reconstructive Orthopedics | Erie | Pennsylvania | 16507 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| University Orthopedics, Inc. | Providence | Rhode Island | 02905 | United States |
| Alpha Clinical Research | Clarksville | Tennessee | 37043 | United States |
| Accurate Clincal Research | Houston | Texas | 77034 | United States |
| Royal North Shore Hospital | St Leonards | New South Wales | NSW 2065 | Australia |
| Rivercity Hospital | Auchenflower | Queensland | QLD4067 | Australia |
| Caboolture Clinical Research Centre | Caboolture | Queensland | QLD4510 | Australia |
| Peninsula Clinical Research | Kippa-Ring | Queensland | QLD 4021 | Australia |
| Menzies Research Institute | Hobart | Tasmania | TAS7000 | Australia |
| Emeritus Research | Malvern | Victoria | VIC 3144 | Australia |
| Gentofte Hospital | Hellerup | Copenhagen | DK-2900 | Denmark |
| Hospital of Aalborg | Aalborg | 9100 | Denmark |
| Rigshospitalet | Copenhagen | DK-2100 | Denmark |
| Dextra | Helsinki | 00305 | Finland |
| Koskiklinikka | Tampere | 33100 | Finland |
| Department of Hand Surgery | Malmö | S-205 02 | Sweden |
| Department of Hand Surgery, Akademiska University Hospital | Uppsala | S-751 85 | Sweden |
| Pulvertaft Hand Clinic | Derby | Derbyshire | DE22 3NE | United Kingdom |
| Newcastle Biomedicine Clinical Research Facility | Newcastle | Newcastle Upon Tyne | NE1 4LP | United Kingdom |
| Welsh Centre for Plastic Surgery Morriston Hospital | Swansea | Wales | SA6 6NL | United Kingdom |
| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003286 | Contracture |
| D017437 | Skin and Connective Tissue Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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