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AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

Primary Purpose

Advanced Dupuytren's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AA4500
Sponsored by
Endo Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Dupuytren's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord.
  • Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.
  • Were naïve to AA4500 treatment or had received only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606).
  • Were judged to be in good health.
  • Must have participated in protocol AUX-CC-857 (NCT00528606).

Exclusion Criteria:

  • Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands.
  • Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon.
  • Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.

Sites / Locations

  • 100 UCLA Medical Plaza, Suite 305
  • Hand Surgery Clinic
  • Hand Surgery Associates, PC
  • The Hand and Upper Extremity Center of Georgia, P.C.
  • Rockford Orthopedic Associates, Ltd.
  • The Indiana Hand Center
  • Brigham and Women's Hospital, Department of Orthopedic Surgery
  • Newton-Wellesley Hospital
  • TRIA Orthopaedic Center
  • Hospital for Special Surgery
  • SUNY Stony Brook - Department of Orthopedics
  • Health Research Institute
  • Hand Microsurgery & Reconstructive Orthopaedics
  • University Orthopedics Center
  • Department of Orthopaedics, Brown University, Rhode Island Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AA4500 0.58 mg

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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
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
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.
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
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.
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

Full Information

First Posted
September 11, 2007
Last Updated
October 26, 2017
Sponsor
Endo Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00528424
Brief Title
AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Official Title
A Phase 3, Open-Label Extension Study of the Safety and Efficacy of AA4500 in the Treatment of Subjects With Advanced Dupuytren's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 2007 (Actual)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endo Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Dupuytren's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
286 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AA4500 0.58 mg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
AA4500
Other Intervention Name(s)
XIAFLEX®
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reduction in Contracture to 5° or Less
Description
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.
Time Frame
Within 30 days after last injection
Secondary Outcome Measure Information:
Title
Clinical Improvement After the Last Injection
Description
Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Time Frame
Baseline, within 30 days after last injection
Title
Percent Reduction From Baseline Contracture After the Last Injection
Description
Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
Time Frame
Baseline, Day 30 after last injection
Title
Change From Baseline Range of Motion After the Last Injection
Description
Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
Time Frame
Baseline, Day 30 after last injection
Title
Time to Reach Clinical Success
Description
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
Time Frame
Within 30 days after last injection
Title
Clinical Success After the First Injection
Description
Clinical success in non-primary joints defined as reduction in contracture to within 0-5° of normal within 30 days of injection.
Time Frame
Within 30 days after first injection
Title
Clinical Improvement After the First Injection
Description
Clinical improvement in non-primary joints defined as ≥50% reduction from baseline in the degree of contracture within 30 days after injection
Time Frame
Baseline, within 30 days after first injection
Title
Percent Reduction From Baseline Contracture After the First Injection
Description
Percent change in degree of contracture in non-primary joints measured as 100 * (baseline contracture - last available post-injection contracture)/baseline contracture.
Time Frame
Baseline, Day 30 after first injection
Title
Change From Baseline Range of Motion After the First Injection
Description
Change in degree of range of motion in non-primary joints measured as last available post-injection range of motion - baseline range of motion
Time Frame
Baseline, Day 30 after first injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion deformity of at least one finger, other than the thumb, that had a contracture at least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable cord. Had a positive "table top test," defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top. Were naïve to AA4500 treatment or had received only one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in AUX-CC-857 ((NCT00528606). Were judged to be in good health. Must have participated in protocol AUX-CC-857 (NCT00528606). Exclusion Criteria: Had a chronic muscular, neurological, or neuromuscular disorder that affected the hands. Had received treatment for advanced Dupuytren's disease within 90 days of enrollment on the joint selected for the initial injection of AA4500, including surgery (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of verapamil and/or interferon. Had a known recent history of stroke, bleeding, a disease process that affected the hands, or other medical condition, which in the investigator's opinion, would make the subject unsuitable for enrollment in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veronica Urdaneta, MD
Organizational Affiliation
Endo Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
100 UCLA Medical Plaza, Suite 305
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Hand Surgery Clinic
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Hand Surgery Associates, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
The Hand and Upper Extremity Center of Georgia, P.C.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Rockford Orthopedic Associates, Ltd.
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
The Indiana Hand Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Brigham and Women's Hospital, Department of Orthopedic Surgery
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
TRIA Orthopaedic Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
SUNY Stony Brook - Department of Orthopedics
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Health Research Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Hand Microsurgery & Reconstructive Orthopaedics
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
Department of Orthopaedics, Brown University, Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125338lbl.pdf
Description
XIAFLEX Prescribing Information

Learn more about this trial

AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease

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