Dupuytren's contracture MedDRA version: 20.0 Level: PT Classification code 10013872 Term: Dupuytren's contracture System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Xiapex
Product Code: AA4500
Pharmaceutical Form: Powder and solvent for solution for injection
Current Sponsor code: AA4500
Sponsors
Auxilium UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible for inclusion into this study, subjects must: 1. Provide a signed and dated informed consent 2. Be a man or woman = 18 years of age 3. Have a diagnosis of Dupuytren’s disease and have at least 2 fixed-flexion contractures on the same hand that are = 20º in PIP and/or MP joints in fingers, other than the thumbs, which are caused by palpable cord(s) suitable for treatment 4. Have a positive “table top test” defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top 5. Have a negative urine pregnancy test at screening and before injection of study drug and be using a highly effective (ie, =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: A subjects will be excluded from study participation if he/she: 1. Received surgery (fasciectomy or surgical fasciotomy) and/or needle aponeurotomy/fasciotomy on the selected joints to be treated within 6 months before administration of study drug 2. Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands 3. Has a known systemic allergy to collagenase or any other excipient of AA4500 4. Has received any collagenase treatments (eg, Santyl® ointment and/or XIAFLEX®/XIAPEX®) within 30 days before injection of study drug in the hand selected for treatment 5. Is currently receiving or plans to receive anticoagulant medication or has received anticoagulant medication (except for = 150 mg aspirin daily) within 7 days before injection of study drug 6. Has a known recent history of stroke, bleeding, or other medical condition, which in the investigator’s opinion would make the subject unsuitable for enrollment in the study 7. Received an investigational drug within 30 days before injection of study drug 8. Is pregnant or intends on becoming pregnant during the study or is breastfeeding a child 9. Has any clinically significant medical history or condition(s), including conditions that affect the hands, that would, in the opinion of the investigator, substantially increase the risk associated with the subject’s participation in the protocol or compromise the scientific objectives of the study 10. Has jewelry on the hand to be treated that cannot be removed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and effectiveness of two concurrent injections of AA4500 administered into two cords in the same hand of a patient with multiple Dupuytren's contractrues: The following variables are safety endpoints: 1. Adverse events including targeted SAEs of tendon rupture/ligament injury and anaphylaxis: Mapped to preferred term using the Medical Dictionary for Regulatory Activities (MedDRA) 2. Vital signs 3. Clinical laboratory tests The primary efficacy variables will be the percent change in total fixed flexion contracture, defined as the sum the fixed flexion measurements of the two simultaneously treated joints, and change from baseline in total range of motion, defined as the sum of the range of motion measurements of the two simultaneously treated joints. Immunogenicity variables include anti-AUX-I/anti-AUX-II antibody levels to AUX-I and AUX-II. ;Secondary Objective: Clinical success of treatment (FFC of = 5° as measured 30 days after the injection to a treated joint); Change from baseline and percent change from baseline in FFC for each treated joint and change from baseline in ROM for each treated joint. The total URAM (validated hand functionality questionnaire) score (sum of all items on URAM scale).; Primary end point(s): The primary objective of this study is to assess the safety of two concurrent injections of AA4500 into the same hand in subjects with multiple Dupuytren’s contractures with palpable cords followed 24 to 72 hours later by a finger extension procedure and compare the rate of occurrence of targeted serious adverse events (tendon rupture/ligament injury and anaphylaxis) to historical rates of the same in clinical studies and post-marketing commercial use. ;Timepoint(s) of evaluation of this end point: 24 to 72 hours after injection, and on Days 15, 31, and 61. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500. ; Timepoint(s) of evaluation of this end point: The actual change and the percent change in the total fixed flexion of the two treated joints will be summarized at Day 31 (overall and by finger extension day). The actual change in total range of motion of the two treated joints will be summarized at Day 31 (overall and by finger extension day). Clinical success, change from baseline and percent change from baseline in FFC, and change from baseline in ROM will be summarized at the visit 30 days after the injection by joint type (MP /PIP). Subject satisfaction with treatment and investigator assessment of improvement with treatment will be summarized at the Day 61 visit. Change from baseline in hand functionality as measured by the total URAM score will be summarized at Day 61 (overall and by hand dominance). | — |
Countries
Australia, Denmark, New Zealand, Sweden, United Kingdom, United States
Contacts
Public ContactVP, Global Clinical Operations
Auxilium UK Limited
Outcome results
None listed