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Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease (JOINT-I)

Primary Purpose

Advanced Dupuytren's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
collagenase clostridium histolyticum
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 one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-855.
  • Were judged to be in good health.

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

  • Hope Research Institute
  • Tucson Orthopedic Institute, P.C.
  • Providence Clinical Research
  • Southern Illinois Hand Center, S.C.
  • Rockford Orthopedic Associates, Ltd.
  • The Indiana Hand Center
  • Pri Via
  • St. Alexius Medical Center
  • David R. Mandel, Inc.
  • St. Vincent Medical Center
  • Hamot Center for Clinical Research
  • Alpha Clinical Research
  • The Rheumatic Disease Clinic of Houston
  • Accurate Clincal Research

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
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

Secondary Outcome Measures

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.
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)
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.
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.
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.
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
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.
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.

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
NCT00528840
Brief Title
Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Acronym
JOINT-I
Official Title
A Phase 3, Open-Label 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
October 2007 (Actual)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 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
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.

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
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AA4500 0.58 mg
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
collagenase clostridium histolyticum
Other Intervention Name(s)
XIAFLEX®, AA4500
Intervention Description
Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.
Primary Outcome Measure Information:
Title
Reduction in Contracture to 5° or Less
Description
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
Time Frame
Within 30 days after the last injection
Secondary Outcome Measure Information:
Title
Clinical Improvement After the Last Injection
Description
Clinical Improvement is defined as >=50% percent reduction from baseline in 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 measured as 100*(baseline contracture -last available post-injection contracture)/baseline contracture)
Time Frame
Baseline, within 30 days after last injection
Title
Change From Baseline Range of Motion After the Last Injection
Description
Change in degree of range of motion measured as last available post-injection range of motion - baseline range of motion.
Time Frame
Baseline, 30 days after last injection
Title
Time to Reach Clinical Success
Description
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.
Time Frame
First evaluation visit on which clinical success is achieved through the Day 30 evaluation
Title
Clinical Success After the First Injection
Description
Clinical Success is defined as reduction in contracture to within 0-5 degrees 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 is defined as >=50% reduction from baseline in the degree of contracture within 30 days after the first 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 is measured as 100* (baseline contracture- last available post-injection contracture)/baseline contracture.
Time Frame
Baseline; within 30 days after first injection
Title
Change From Baseline Range of Motion After the First Injection
Description
Change in degree of range of motion measured as last available post-injection range of motion-baseline range of motion.
Time Frame
Baseline; within 30 days 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 one or two injections of AA4500 for the treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853, or AUX-CC-855. Were judged to be in good health. 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
Hope Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85050
Country
United States
Facility Name
Tucson Orthopedic Institute, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85172
Country
United States
Facility Name
Providence Clinical Research
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Southern Illinois Hand Center, S.C.
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
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
Pri Via
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
St. Alexius Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
David R. Mandel, Inc.
City
Mayfield
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
Facility Name
St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Hamot Center for Clinical Research
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Facility Name
Alpha Clinical Research
City
Clarksville
State/Province
Tennessee
ZIP/Postal Code
37043
Country
United States
Facility Name
The Rheumatic Disease Clinic of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Accurate Clincal Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
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

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

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