MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

This study has been completed.
Sponsor:
Collaborator:
Auxilium Pharmaceuticals, Inc
Information provided by (Responsible Party):
Scott Wolfe, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01450397
First received: October 10, 2011
Last updated: May 19, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine the effects of XIAFLEX on your finger through MRI.


Condition Intervention Phase
Dupuytren's Disease
Biological: XIAFLEX
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MRI Results in Dupuytren's Contracture Before and After Injection With Xiaflex

Resource links provided by NLM:


Further study details as provided by Hospital for Special Surgery, New York:

Primary Outcome Measures:
  • The Measured Change in Volume of the Cord by MRI Before and After XIAFLEX Injection and Manual Manipulation. [ Time Frame: Baseline and 30 days ] [ Designated as safety issue: No ]
    Change in Volume (millimeter cubed) of the Cord by MRI between Baseline and 30 days after XIAFLEX injection and manual manipulation.


Enrollment: 5
Study Start Date: March 2011
Study Completion Date: February 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
XIAFLEX
XIAFlEX
Biological: XIAFLEX
One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
Other Name: Collagenase

Detailed Description:

Collagenase injections for the treatment of Dupuytren's Contracture is a newly approved protocol which has shown early efficacy. There are very few studies which examine the MRI appearance of Dupuytren's disease. There are no studies that evaluate the condition of the cord after collagenase injection.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has a diagnosis of Dupuytren's Disease affecting only the metacarpophalangeal joint of the 4th or 5th finger.
  • Subject has only one finger affected by the disease.
  • Patients will be 35 years of age of older.
  • Patients will be able to read, speak, and understand English or have available adequate translation assistance and be able to provide voluntary written consent to participate.

Exclusion Criteria:

  • Female patients who are nursing or pregnant, or plan to become pregnant during the treatment phase.
  • Patient has a chronic muscular, neurological or neuromuscular disorder that affects the hands.
  • Patient has known allergy to collagenase or any other excipient of Xiaflex.
  • Patient has received any collagenase treatments before the first dose of Xiaflex.
  • Patient with abnormal coagulation, including patients who have received anticoagulant medications other than low-dose aspirin within 7 days of the injection.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01450397

Locations
United States, New York
Hosptial for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Scott Wolfe
Auxilium Pharmaceuticals, Inc
Investigators
Principal Investigator: Scott W Wolfe, MD Hospital for Special Surgery, New York
  More Information

No publications provided

Responsible Party: Scott Wolfe, Prinicpal Investigator, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01450397     History of Changes
Other Study ID Numbers: 11052
Study First Received: October 10, 2011
Results First Received: October 29, 2013
Last Updated: May 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Hospital for Special Surgery, New York:
Dupuytren's Contracture

Additional relevant MeSH terms:
Contracture
Dupuytren Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 21, 2014