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

NCT00528840 | Completed Phase 3 Results

• 1 other identifier: AUX-CC-856
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 14

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.

Conditions

Advanced Dupuytren's Disease

Outcome Measures

Primary Outcomes (1)

• 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

  Within 30 days after the last injection

Secondary Outcomes (8)

• Clinical Improvement After the Last Injection

  Baseline; within 30 days after last injection

• Percent Reduction From Baseline Contracture After the Last Injection

  Baseline, within 30 days after last injection

• Change From Baseline Range of Motion After the Last Injection

  Baseline, 30 days after last injection

• Time to Reach Clinical Success

  First evaluation visit on which clinical success is achieved through the Day 30 evaluation

• Clinical Success After the First Injection

  Within 30 days after first injection

Study Arms (1)

AA4500 0.58 mg

EXPERIMENTAL

Biological: collagenase clostridium histolyticum

Interventions

collagenase clostridium histolyticum BIOLOGICAL

Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.

Also known as: XIAFLEX®, AA4500

AA4500 0.58 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Endo Pharmaceuticals: lead

Study Sites (14)

Hope Research Institute

Phoenix, Arizona, 85050, United States

Location

Tucson Orthopedic Institute, P.C.

Tucson, Arizona, 85172, United States

Location

Providence Clinical Research

Burbank, California, 91505, United States

Location

Southern Illinois Hand Center, S.C.

Effingham, Illinois, 62401, United States

Location

Rockford Orthopedic Associates, Ltd.

Rockford, Illinois, 61107, United States

Location

The Indiana Hand Center

Indianapolis, Indiana, 46260, United States

Location

Pri Via

Wichita, Kansas, 67214, United States

Location

St. Alexius Medical Center

Bismarck, North Dakota, 58501, United States

Location

David R. Mandel, Inc.

Mayfield, Ohio, 44143, United States

Location

St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Hamot Center for Clinical Research

Erie, Pennsylvania, 16550, United States

Location

Alpha Clinical Research

Clarksville, Tennessee, 37043, United States

Location

The Rheumatic Disease Clinic of Houston

Houston, Texas, 77004, United States

Location

Accurate Clincal Research

Houston, Texas, 77034, United States

Location

Related Links

• XIAFLEX Prescribing Information

MeSH Terms

Interventions

Microbial Collagenase

Intervention Hierarchy (Ancestors)

Collagenases; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Results Point of Contact

• Title: Clinical Trial Coordinator
• Organization: Endo Pharmaceuticals, Inc.

clinicalsite.inquiries@endo.com

Study Officials

• Veronica Urdaneta, MD

  Endo Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2007
• First Posted: September 12, 2007
• Study Start: October 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 2, 2017
• Results First Posted: October 22, 2010

Record last verified: 2017-10

Locations

US (14)