Retreatment of Recurrent Dupuytren's Contractures



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:10/7/2017
Start Date:March 2012
End Date:October 2013

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Retreatment of Recurrent Contractures in Joints Effectively Treated With AA4500 (Collagenase Clostridium Histolyticum [XIAFLEX®/XIAPEX®]) in an Auxilium-sponsored Phase 3 Study in the United States, Australia, and Europe

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.

Inclusion Criteria:

1. Provide written informed consent

2. Be currently participating in the AUX-CC-860 follow-up study

3. Have at least one joint with all of the following:

- The joint was effectively treated (had a correction to 5 degrees or less at the
Day 30 evaluation after the last injection of AA4500) in a previous Auxilium
Phase 3 study

- The effectively treated joint has an increase in contracture of at least 20
degrees compared with the Day 30 value after the last injection of AA4500 in a
previous Auxilium Phase 3 study

- A palpable cord is present in the joint to be treated

4. Be able to comply with the study visit schedule as specified in the protocol

Exclusion Criteria:

1. Is a pregnant or lactating female or female intending to become pregnant during the
study

2. Has hypersensitivity to AA4500 or any of the AA4500 excipients

3. Is currently receiving or plans to receive anticoagulant medication or has received
anticoagulant medication (except for equal to or less than 150 mg aspirin daily and
over-the-counter nonsteroidal antiinflammatory drugs [NSAIDs]) within 7 days before
injection of AA4500
We found this trial at
8
sites
Indianapolis, Indiana 46260
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Indianapolis, IN
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Erie, PA
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Kippa Ring, Queensland 4021
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Kippa Ring,
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Marquette, Michigan 49855
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Marquette, MI
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523 East 72nd Street
New York, New York 10021
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New York, NY
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3555 Northwest 58th Street
Oklahoma City, Oklahoma 73109
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from
Oklahoma City, OK
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Phoenix, Arizona 85050
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Phoenix, AZ
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Rockford, Illinois 61107
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from
Rockford, IL
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