Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AA4500 0.58 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AA4500 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Contracture to 5° or Less | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement After the 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Veronica Urdaneta, MD | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 100 UCLA Medical Plaza, Suite 305 | Los Angeles | California | 90095 | United States | ||
| Hand Surgery Clinic |
Not provided
| Label | URL |
|---|---|
| XIAFLEX Prescribing Information | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 | 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 | 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 | 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 | 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 | 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 | 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 |
| Palo Alto |
| California |
| 94304 |
| United States |
| Hand Surgery Associates, PC | Denver | Colorado | 80210 | United States |
| The Hand and Upper Extremity Center of Georgia, P.C. | Atlanta | Georgia | 30342 | United States |
| Rockford Orthopedic Associates, Ltd. | Rockford | Illinois | 61107 | United States |
| The Indiana Hand Center | Indianapolis | Indiana | 46260 | United States |
| Brigham and Women's Hospital, Department of Orthopedic Surgery | Boston | Massachusetts | 02115 | United States |
| Newton-Wellesley Hospital | Newton | Massachusetts | 02462 | 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 |
| Health Research Institute | Oklahoma City | Oklahoma | 73109 | United States |
| Hand Microsurgery & Reconstructive Orthopaedics | Erie | Pennsylvania | 16550 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| Department of Orthopaedics, Brown University, Rhode Island Hospital | Providence | Rhode Island | 02905 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AA4500 0.58 mg | Collagenase clostridium histolyticum 0.58 mg injected into MP and/or PIP joints |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Contracture to 5° or Less | 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. | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Number | Percentage of joints | Within 30 days after last injection | Joints | Joints |
|
|
| ||||||||||||||||||||||||||
| Secondary | Clinical Improvement After the Last Injection | Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Number | Percentage of joints | Baseline, within 30 days after last injection | Joints | Joints |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Reduction From Baseline Contracture After the Last Injection | Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture. | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Mean | Standard Deviation | Percentage of change | Baseline, Day 30 after last injection | Joints | Joints |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline Range of Motion After the 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 | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Mean | Standard Deviation | Degrees | Baseline, Day 30 after last injection | Joints | Joints |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Reach Clinical Success | 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 | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Number | Percentage of Joints | Within 30 days after last injection | Joints | Joints |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Success After the First Injection | Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection. | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Number | Percentage of Joints | Within 30 days after first injection | Joints | Joints |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Improvement After the First Injection | Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Number | Percentage of Joints | Baseline, within 30 days after first injection | Joints | Joints |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Reduction From Baseline Contracture After the First Injection | Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture. | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Mean | Standard Deviation | Percentage of change | Baseline, Day 30 after first injection | Joints | Joints |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline Range of Motion After the 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 | Evaluable non-primary joints treated with AA4500 with baseline fixed flexion contracture >5° and at least 1 post-injection contracture measurement. For the purpose of analysis, 13 subjects with non-primary joints treated with AA4500 in double-blind study AUX-CC-857 are included in overall number of participants. | Posted | Mean | Standard Deviation | Degrees | Baseline, Day 30 after first injection | Joints | Joints |
|
|
From the time of study drug administration until 30 days after completion of or discharge from the study
This study was designed to be part of the larger clinical program. For information regarding XIAFLEX-associated Serious and Non-serious Adverse events please refer to the XIAFLEX Medication Guide & XIAFLEX Prescribing Information (see links above)
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AA4500 0.58 mg | collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints | 9 | 286 | 171 | 286 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Chronic myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Finger deformity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Meningioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (8.0) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Tenderness | General disorders | MedDRA (8.0) | Non-systematic Assessment |
|
Auxilium Pharmaceuticals, Inc. agreements may vary with individual investigators but will not prohibit any investigator from publishing. Auxilium supports the publication of results from all centers of a multicenter trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals Inc. | clinicalsite.inquiries@endo.com |
| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| ID | Term |
|---|---|
| D017364 | Collagenases |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
Not provided
Not provided
| Joints |
|
|
| Joints |
|
|
| Joints |
|
|
| Joints |
|
|
| Joints |
|
|
| Joints |
|
|
| Joints |
|
|
| Joints |
|
|