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The objectives of this study are to assess the safety and efficacy of AA4500 in the retreatment of recurrent contractures in joints that were effectively treated with AA4500 in a previous Auxilium-sponsored Phase 3 study.
Open-label, Phase 4 study in subjects who are currently participating in the long-term follow-up study (ie, AUX-CC-860) in the United States, Australia, or Europe and who have recurrence of contracture (ie, joint contracture increases by at least 20 degrees compared with the Day 30 value after the last injection in a Phase 3 Auxilium-sponsored study and a palpable cord present) in a joint that was effectively treated (ie, reduction in contracture to 5 degrees or less 30 days after the last injection) with AA4500 in a Phase 3 Auxilium-sponsored study.
Subjects who experience recurrence of contracture in one or more effectively treated joints may be enrolled in this retreatment study after the investigator determines subject eligibility and after informed consent has been obtained. The investigator will treat the cord affecting the recurrent joint with up to three injections. Only one recurrent joint will be treated in this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XIAFLEX/XIAPEX MP Joint | Experimental | Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord |
|
| XIAFLEX/XIAPEX PIP Joint | Experimental | Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collagenase clostridium histolyticum | Biological | up to three 0.58 mg injections |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Success | Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500 | 30 days after last injection |
| Percent Change From Baseline in Degree of Contracture | Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees | Baseline and 30 days after last injection |
| Change in Range of Motion | Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees | Baseline and 30 days after last injection |
| Measure | Description | Time Frame |
|---|---|---|
| Physician Global Assessment of Improvement | Physician global assessment of change (improvement) in subject's Dupuytren's contracture | 30 days after last injection |
| Subject Global Assessment of Satisfaction |
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Inclusion Criteria:
Provide written informed consent
Be currently participating in the AUX-CC-860 follow-up study
Have at least one joint with all of the following:
Be able to comply with the study visit schedule as specified in the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Veronica Urdaneta, MD, MPPH | Endo USA Inc., a Keenova Therapeutics Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HOPE Research Institute | Phoenix | Arizona | 85050 | United States | ||
| Rockford Orthopedic Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | XIAFLEX/XIAPEX | XIAFLEX/XIAPEX: up to three 0.58 mg injections |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Subject global assessment of overall treatment satisfaction
| 30 days after last injection |
| Recurrence of Contracture | Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points. | Day 365 |
| Rockford |
| Illinois |
| 61107 |
| United States |
| The Indiana Hand to Shoulder Center | Indianapolis | Indiana | 46260 | United States |
| Marquette General Health System | Marquette | Michigan | 49855 | United States |
| East River Professional Building | New York | New York | 10021 | United States |
| Health Reserarch Institute | Oklahoma City | Oklahoma | 73109 | United States |
| Hand Microsurgery and Reconstructive Orthopaedics | Erie | Pennsylvania | 16507 | United States |
| Peninsula Private Hospital | Kippa-Ring | Queensland | 4021 | Australia |
| AusTrials Sherwood | Sherwood | Queensland | 4075 | Australia |
| Emeritus Research | Malvern East | Victoria | 3145 | Australia |
| Uppsala Akademiska University Hospital | Uppsala | SE | SE-751 | Sweden |
| Pulvertaft Hand Center | Derby | GB | DE22 3NE | United Kingdom |
| Newcastle Upon Tyne Hospitals | Newcastle | GB | NE1 4LP | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | XIAFLEX/XIAPEX | XIAFLEX/XIAPEX: up to three 0.58 mg injections |
| 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 |
| |||||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | 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 | Clinical Success | Clinical success defined as reduction in fixed-flexion contracture to less than or equal to 5 degrees 30 days after the last injection of AA4500 | Efficacy assessment based on modified intent-to-treat (mITT) population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure | Posted | Number | 95% Confidence Interval | percentage of particpants | 30 days after last injection |
|
|
| ||||||||||||||||||||||||||||
| Primary | Percent Change From Baseline in Degree of Contracture | Change in fixed-flection contracture measured in degrees where a decrease of 100% would correspond to a reduction in contracture to 0 degrees | Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure | Posted | Mean | Standard Deviation | percentage of contracture change | Baseline and 30 days after last injection |
|
| |||||||||||||||||||||||||||||
| Primary | Change in Range of Motion | Range of motion defined as difference between full flexion angle and full extension angle expressed in degrees | Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure | Posted | Mean | Standard Deviation | degrees | Baseline and 30 days after last injection |
|
| |||||||||||||||||||||||||||||
| Secondary | Physician Global Assessment of Improvement | Physician global assessment of change (improvement) in subject's Dupuytren's contracture | Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure | Posted | Number | participants | 30 days after last injection |
|
| ||||||||||||||||||||||||||||||
| Secondary | Subject Global Assessment of Satisfaction | Subject global assessment of overall treatment satisfaction | Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure | Posted | Number | participants | 30 days after last injection |
|
| ||||||||||||||||||||||||||||||
| Secondary | Recurrence of Contracture | Recurrence of contracture in the joint at day 365 that was successfully treated 30 days after last injection assessed. Recurrence was defined as 20 degree or greater increase of contracture of the treated joint at day 365 or medication intervention of the treated joint between the 2 time points. | Efficacy assessment based on mITT population which includes all enrolled subjects who received at least 1 AA4500 injection to the treated joint and had at least 1 post-injection efficacy measure; only joints that were successfully treated (reduction in contracture to 5 degrees or less) 30 days after last injection were assessed | Posted | Number | joints | Day 365 | Joints | Joints |
|
|
1 year
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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 | XIAFLEX/XIAPEX | XIAFLEX/XIAPEX: up to three 0.58 mg injections | 4 | 52 | 44 | 52 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerebellar infarction | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment | Resulted in death |
|
| Acute coronary syndrome | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Dupuytren's contracture | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oedema peripheral | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Injection site haematoma | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
| |
| Injection site pruritus | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA (11.1) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (11.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals, Inc. | clinicalsite.inquiries@endo.com |
| ID | Term |
|---|---|
| D004387 | Dupuytren Contracture |
| D003286 | Contracture |
| 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 |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007592 | Joint Diseases |
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| ID | Term |
|---|---|
| D003012 | Microbial Collagenase |
| C570746 | xiapex |
| 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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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United Kingdom |
|
| Sweden |
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| Joints |
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