Phase 3
N=715
Safety and Efficacy of Two Concurrent Injections of AA4500 in Adult Subjects With Multiple Dupuytren's Contractures
Dupuytren's Contracture
Bottom Line
View on ClinicalTrials.gov: NCT01674634 ↗Enrolled (actual)
715
Serious AEs
2.1%
Results posted
Feb 2015
Primary outcome: Primary: Percent Change From Baseline in Total Fixed Flexion — 74.41 percentage of contracture change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- XIAFLEX / XIAPEX (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Endo Pharmaceuticals
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Total Fixed Flexion |
74.41 | — |
| PRIMARY Change From Baseline in Total Range of Motion |
66.6 | — |
| SECONDARY Clinical Success |
317; 394; 579; 158 | — |
| SECONDARY Clinical Improvement |
96; 157; 800; 395 | — |
| SECONDARY Subject Assessment of Satisfaction With Treatment at Day 31 |
461; 198; 38; 9; 6; 12 | — |
| SECONDARY Subject Assessment of Satisfaction With Treatment at Day 61 |
496; 167; 38; 11; 8; 4 | — |
| SECONDARY Investigator Assessment of Improvement With Treatment at Day 31 |
375; 271; 51; 4; 3; 0 | — |
| SECONDARY Investigator Assessment of Improvement With Treatment at Day 61 |
382; 263; 62; 7; 2; 0 | — |
| SECONDARY Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 31 |
-11.3 | — |
| SECONDARY Change From Baseline for Unité Rhumatologique Des Affections de la Main Scale at Day 61 |
-12.3 | — |
Summary
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.
The secondary objective is to evaluate the efficacy of two concurrent injections of AA4500.
Eligibility Criteria
Inclusion Criteria
- Provide a signed and dated informed consent
- Be a man or woman ≥ 18 years of age
- 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
- Have a positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top
- Have a negative urine pregnancy test at screening and before injection of study drug and be using a highly effective (ie, < 1% failure rate) contraception method as judged by the investigator (eg, abstinence, intrauterine device [IUD], hormonal [estrogen/progestin] contraceptives, or barrier control) for at least one menstrual cycle prior to study enrollment and for the duration of the study or be surgically sterile (if female of childbearing potential); or be a postmenopausal female (no menses for at least 1 year or hysterectomy).
- Be able to comply with the study visit schedule as specified in the protocol
Exclusion Criteria
A subject will be excluded from study participation if he/she:
- 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
- Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands
- Has a known systemic allergy to collagenase or any other excipient of AA4500
- 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
- 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
- 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
- Received an investigational drug within 30 days before injection of study drug
- Is pregnant or intends on becoming pregnant during the study or is breastfeeding a child
- 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
- Has jewelry on the hand to be treated that cannot be removed
Data sourced from ClinicalTrials.gov (NCT01674634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.