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This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one finger, other than the thumb, that was at least 20° as measured by finger goniometry and was suitable for evaluation and injection were enrolled.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AA4500 0.58 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| collagenase clostridium histolyticum | Biological | Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Contracture to 5° or Less | The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection | Within 30 days after the last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Improvement After the Last Injection | Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection. | Baseline; within 30 days after last injection |
| Percent Reduction From Baseline Contracture After the Last Injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Urdaneta, MD | Endo USA Inc., a Keenova Therapeutics Company | 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 |
|---|---|
| XIAFLEX Prescribing Information | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AA4500 0.58 mg | collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture) |
| Baseline, within 30 days after last injection |
| Change From Baseline Range of Motion After the Last Injection | Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion. | Baseline, 30 days after last injection |
| Time to Reach Clinical Success | Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories. | First evaluation visit on which clinical success is achieved through the Day 30 evaluation |
| Clinical Success After the First Injection | Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection. | Within 30 days after first injection |
| Clinical Improvement After the First Injection | Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection | Baseline; within 30 days after first injection |
| Percent Reduction From Baseline Contracture After the First Injection | Percent change in degree of contracture is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture. | Baseline; within 30 days after first injection |
| Change From Baseline Range of Motion After the First Injection | Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion. | Baseline; within 30 days after first injection |
| Tucson |
| Arizona |
| 85172 |
| United States |
| Providence Clinical Research | Burbank | California | 91505 | 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 |
| Pri Via | Wichita | Kansas | 67214 | United States |
| St. Alexius Medical Center | Bismarck | North Dakota | 58501 | United States |
| David R. Mandel, Inc. | Mayfield | Ohio | 44143 | United States |
| St. Vincent Medical Center | Portland | Oregon | 97225 | United States |
| Hamot Center for Clinical Research | Erie | Pennsylvania | 16550 | United States |
| Alpha Clinical Research | Clarksville | Tennessee | 37043 | United States |
| The Rheumatic Disease Clinic of Houston | Houston | Texas | 77004 | United States |
| Accurate Clincal Research | Houston | Texas | 77034 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | AA4500 0.58 mg | collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (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 |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| 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 | The Primary Outcome Measure is the percentage of joints that were successfully treated where "successfully treated" was defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection | Intent to treat population (ITT) defined as all subjects who received at least one injection. | Posted | Number | percentage of joints | Within 30 days after the last injection | joints | joints |
|
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| ||||||||||||||||||||||||||
| Secondary | Clinical Improvement After the Last Injection | Clinical Improvement is defined as >=50% percent reduction from baseline in degree of contracture within 30 days after injection. | Intent to treat population (ITT) defined as all subjects who received at least one injection. | Posted | Number | percent of joints | Baseline; within 30 days after last injection | Number of joints | Number of joints |
|
| |||||||||||||||||||||||||||
| Secondary | Percent Reduction From Baseline Contracture After the Last Injection | Percent change in degree of contracture measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture) | Intent to treat population (ITT) defined as all subjects who received at least one injection. | Posted | Mean | Standard Deviation | percentage of joints | Baseline, within 30 days after last injection | joints | joints |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline Range of Motion After the Last Injection | Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion. | Intent to treat population (ITT) defined as all subjects who received at least one injection. | Posted | Mean | Standard Deviation | degrees | Baseline, 30 days after last injection | Number of Joints | Number of Joints |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Reach Clinical Success | Clinical success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection, displayed in post-injection timepoint categories. | Intent to treat population (ITT) defined as all subjects who received at least one injection. | Posted | Number | percentage of joints | First evaluation visit on which clinical success is achieved through the Day 30 evaluation | joints | joints |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Success After the First Injection | Clinical Success is defined as reduction in contracture to within 0-5 degrees of normal within 30 days of injection. | Intent to treat population (ITT) defined as all subjects who received at least one injection. | Posted | Number | percentage of joints | Within 30 days after first injection | joints | joints |
|
| |||||||||||||||||||||||||||
| Secondary | Clinical Improvement After the First Injection | Clinical Improvement is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first injection | Intent to treat population (ITT) defined as all subjects who received at least one injection. | 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 is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture. | Intent to treat population (ITT) defined as all subjects who received at least one injection. | Posted | Mean | Standard Deviation | percentage of change | Baseline; within 30 days after first injection | joints | joints |
|
| ||||||||||||||||||||||||||
| Secondary | Change From Baseline Range of Motion After the First Injection | Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion. | Intent to treat population (ITT) defined as all subjects who received at least one injection. | Posted | Mean | Standard Deviation | degrees | Baseline; within 30 days after first injection | Joints | Joints |
|
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Non-serious adverse events (non-SAEs) were collected from time of study drug administration, serious adverse events (SAEs) were collected from time subject signed ICF. Non-SAEs & SAEs were collected until 30 days after completion or discharge from study.
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 and AUX-CC-859) and 7 non-pivotal studies were evaluated.
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| 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 | 11 | 201 | 197 | 201 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Finger amputation | Surgical and medical procedures | MedDRA (8.0) | Non-systematic Assessment |
| |
| Intervertebral discitis | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Rocky mountain spotted fever | Infections and infestations | MedDRA (8.0) | Non-systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Small intestinal perforation | Gastrointestinal disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Thyroid gland cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Blood blister | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Injection site haemorrhage | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Injection site pain | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Injection site pruritus | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Injection site swelling | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Non-systematic Assessment |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (8.0) | Non-systematic Assessment |
| |
| Swelling | General disorders | MedDRA (8.0) | Non-systematic Assessment |
| |
| Tenderness | General disorders | MedDRA (8.0) | Non-systematic Assessment |
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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 preceed 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 |
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