ong term follow up of subjects treated with AA4500 in a previous qualifying Auxilium study

• Conditions: MedDRA version: 14.1Level: PTClassification code 10013872Term: Dupuytren's contractureSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]; Dupuytren's contracture

• Registration Number: EUCTR2008-007872-99-GB
• Lead Sponsor: Auxilium UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 850

Inclusion Criteria

This study is intended to recruit study participants who:

Have received at least one injection of AA4500 in one of the previously conducted phase III studies (AUX-CC-854, AUX-CC-856, AUX-CC-857/858 and AUX-CC-859)

Are able and willing to comply with the yearly assessments as outlined in the protocol

Voluntarily sign and date an informed consent agreement approved by the appropriate Institutional Review Board/Independent Ethics Committee.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

There are no specific exclusion criteria for this study provided that the subject meets all of the inclusion criteria.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified