CORRECT: COmmunity RegistRy Study Evaluating Dupuytren's Contracture Treatment

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01715467
First received: October 25, 2012
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

This observational study will prospectively collect data on treatment options, patient/investigator satisfaction, requirement for retreatment or additional treatment, and long-term outcomes of 3 treatment modalities(XIAFLEX, fasciectomy, or fasciotomy/needle aponeurotomy) in patients with Dupuytren's contracture. In addition, this study will provide additional health economics and utilization data.


Condition
Dupuytren's Contracture

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Community Registry Study Evaluating Dupuytren's Contracture Treatment. A Prospective, Observational, Longitudinal, Multicenter Study of the Treatment Patterns and Outcomes in Patients With Dupuytren's Contracture.

Further study details as provided by Auxilium Pharmaceuticals:

Primary Outcome Measures:
  • The primary objective is to collect real-world data regarding patient reported outcomes of the 3 primary treatment modalities in patients with Dupuytren's contracture. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Examine safety, effectiveness and association between treatments and selected healthcare utilization and patient report outcomes. [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

    The secondary objectives are as follows:

    • Examine the safety trends of various treatment options in patients with Dupuytren's contracture
    • Examine the effectiveness trends of various treatment options, specifically evaluating long term contracture recurrence
    • Examine the association between various treatment regimens and healthcare resource utilization
    • Examine the association between various treatments and patient-reported outcomes (PROs) such as disease burden, ADLs, hand functionality, work performance, time to return to work, treatment satisfaction, and patient preference


Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Detailed Description:

This is a prospective, multi-center, observational study. Patients will be recruited based on the usual care presentation at each investigative site, as regular practice would dictate. Consecutive patients deemed eligible for the study by their physician will be invited to participate during their usual care visit. Enrolled patients will receive evaluations and treatment for Dupuytren's contracture according to the standard of care and clinical practice at each study site. No study-specific visits will be required as part of the study. Treatment and Follow-up Visits will be determined by the treating physician. Treatments received for Dupuytren's contracture will be recorded (ie, XIAFLEX, fasciectomy, or fasciotomy/needle aponeurotomy), including initial treatment and any subsequent therapy. The full prescribing information and medication guide for XIAFLEX is provided in this protocol as reference (Appendix B). Patient data (including treatment outcomes, joint contracture measured by the treating physician, and evidence of recurrence) and health care resource utilization data will be drawn from the patients' medical records, examination, and patient interviews. These data will be recorded via a web-based electronic data collection (EDC) system.

PROs will be collected by self-completed questionnaires given to each patient via web-based data collection or telephone interviews. The site will follow up with the patient according to usual practice. Information from the patient's visit may include goniometry and the physician's assessment of treatment outcome and healthcare utilization. Patients will be considered enrolled in the study for a maximum of 4 years post-enrollment or until death, withdrawal of consent, loss to follow-up, or study closure.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community based sample

Criteria

Inclusion Criteria:

  • Women or men 18 years of age or older
  • Patients with a Dupuytren's contracture of at least a single joint and a desire for correction
  • Patients who are able to read and understand English
  • Patients who are capable of understanding and cooperating with the requirements of the study
  • Patients who are willing and able to respond to the posttreatment assessments via telephone or internet
  • Patients must provide written informed consent, indicating that they understand the purpose of and requirements of the study and are willing to participate in the study.

Exclusion Criteria:

  • Patients who decide not to pursue correction of the Dupuytren's contracture.
  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: NCT01715467

  Show 27 Study Locations
Sponsors and Collaborators
Auxilium Pharmaceuticals
Investigators
Study Director: James Tursi, MD Auxilium Pharmaceuticals, Inc
  More Information

No publications provided

Responsible Party: Auxilium Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01715467     History of Changes
Other Study ID Numbers: AUX-CC-901
Study First Received: October 25, 2012
Last Updated: July 16, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Auxilium Pharmaceuticals:
Dupuytren
Contracture
Auxilium
XIAFLEX

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

ClinicalTrials.gov processed this record on October 23, 2014