Clinical trial NCT01229436: Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)
Official title: Prospective Open-Label Investigation Of The Non-surgical Treatment With Collagenase Clostridium Histolyticum (Xiapex)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dupuytren's Contracture
Keywords: Dupuytren's
treatment
injection
recovery
health care resources
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-10-27
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).


Eligibility criteria: Inclusion Criteria:

* Presenting with a Dupuytren's contracture of at least 20 degrees caused by a palpable cord in at least one finger other than the thumb.
* Positive "table top test" defined as the inability to simultaneously place the affected finger(s) and palm flat against a table top.

Exclusion Criteria:

* Received a treatment on the selected joint, within 90 days of enrollment in the study, for Dupuytren's contracture including needle aponeurotomy or any surgical procedure
* On anticoagulant medication or has received anticoagulant medication (except aspirin less than 150 mg daily) within 7 days before the first injection
* Has a chronic muscular, neurological, or neuromuscular disorder that affects the hands

Primary outcomes:
measure: Total Passive Extension Deficit (TPED) at Baseline for First Injection
timeFrame: Baseline for first injection
measure: Total Passive Extension Deficit (TPED) at Baseline for Second Injection
timeFrame: Baseline for second injection
measure: Total Passive Extension Deficit (TPED) at Baseline for Third Injection
timeFrame: Baseline for third injection
measure: Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection
timeFrame: Baseline for fourth injection
measure: Total Passive Extension Deficit (TPED) at Day 1 After First Injection
timeFrame: Day 1 after first injection
measure: Total Passive Extension Deficit (TPED) at Day 7 After First Injection
timeFrame: Day 7 after first injection
measure: Total Passive Extension Deficit (TPED) at Day 30 After First Injection
timeFrame: Day 30 after first injection
measure: Total Passive Extension Deficit (TPED) at Day 1 After Second Injection
timeFrame: Day 1 after second injection
measure: Total Passive Extension Deficit (TPED) at Day 7 After Second Injection
timeFrame: Day 7 after second injection
measure: Total Passive Extension Deficit (TPED) at Day 30 After Second Injection
timeFrame: Day 30 after second injection
measure: Total Passive Extension Deficit (TPED) at Day 1 After Third Injection
timeFrame: Day 1 after third injection
measure: Total Passive Extension Deficit (TPED) at Day 7 After Third Injection
timeFrame: Day 7 after third injection
measure: Total Passive Extension Deficit (TPED) at Day 30 After Third Injection
timeFrame: Day 30 after third injection
measure: Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection
timeFrame: Day 1 after fourth injection
measure: Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection
timeFrame: Day 7 after fourth injection
measure: Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection
timeFrame: Day 30 after fourth injection
measure: Total Passive Extension Deficit (TPED) at Day 90 After Last Injection
timeFrame: Day 90 after last injection
measure: Total Passive Extension Deficit (TPED) at Day 180 After Last Injection
timeFrame: Day 180 after last injection
Secondary outcomes:
measure: Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
timeFrame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection
measure: Change From Baseline in Total Passive Extension Deficit (TPED) at Day 1, 7 and 30 After First, Second, Third and Fourth Injection, Day 90 and 180 After Last Injection
timeFrame: Baseline for first, second, third, fourth injection; Day 1, 7, 30 after first, second, third, fourth injection; Follow-up Day 90, 180 after last injection
measure: Change From Baseline in Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints at Day 1, 7 and 30 After First, Second and Third Injection, Day 90 and 180 After Last Injection
timeFrame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
measure: Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints
timeFrame: Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection
measure: Participant Global Assessment of Treatment Satisfaction and Disease Severity
timeFrame: Baseline for cycle 1, 2, 3, 4, 5; Cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
measure: Physician Global Assessment of Treatment Satisfaction and Disease Severity
timeFrame: Baseline for cycle 1, 2, 3, 4, 5; cycle 1 Day 30 (C1D30), C2D30, C3D30, C4D30, C5D30; Follow-up (FU) Day 90, 180 after last injection
measure: Number of Participants With Type of Concomitant Pain Medication Used
timeFrame: Screening up to Day 180 after last injection
measure: Number of Days of Concomitant Pain Medication Usage
timeFrame: Screening up to Day 180 after last injection
measure: Number of Days Assessed on Dupuytren's Treatment Assessment Daily Diary Questionnaire
timeFrame: C1D1 to C1D30, C2D1 to C2D30, C3D1 to C3D30, C4D1 to C4D30, C5D1 to C5D30
measure: Time to Recovery
timeFrame: Up to Day 30 after first, second and third injection
measure: Hand Functionality: Unite Rhumatologique Des Affections de la Main (URAM) Scale Total Score
timeFrame: Baseline for cycle 1, 2, 3, 4, 5; C1D30, C2D30, C3D30, C4D30, C5D30; Follow-up Day 90, 180 after last injection
measure: Number of Participants With Response Assessed on Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
timeFrame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
measure: Number of Events Including Visits, Surgeries, Tests or Devices as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
timeFrame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
measure: Number of Days as Assessed Using Dupuytren's Healthcare Resource Utilization (HCRU) Questionnaire
timeFrame: Baseline for cycle 1, 2, 3, 4, 5; C1D7, C1D30, C2D7, C2D30, C3D7, C3D30, C4D7, C4D30, C5D7, C5D30; Follow-up Day 90, 180 after last injection
Other outcomes:
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: Screening up to Day 180 after last injection
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Screening up to Day 180 after last injection
measure: Number of Participants With Anti-Drug Antibody (ADA)
timeFrame: Screening, Follow-up Day 180 after last injection
Locations:
city: Copenhagen
country: Denmark
facility: Pfizer Investigational Site
city: Silkeborg
country: Denmark
facility: Pfizer Investigational Site
city: Montpellier cedex 5
country: France
facility: Pfizer Investigational Site
city: Nice
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Paris
country: France
facility: Pfizer Investigational Site
city: Bad Neustadt
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bonn
country: Germany
facility: Pfizer Investigational Site
city: Muenster
country: Germany
facility: Pfizer Investigational Site
city: Nurnberg
country: Germany
facility: Pfizer Investigational Site
city: Tubingen
country: Germany
facility: Pfizer Investigational Site
city: Miskolc
country: Hungary
facility: Pfizer Investigational Site
city: Sesto San Giovanni
country: Italy
facility: Pfizer Investigational Site
state: Milano
city: Modena
country: Italy
facility: Pfizer Investigational Site
city: Savona
country: Italy
facility: Pfizer Investigational Site
city: Elche
country: Spain
facility: Pfizer Investigational Site
state: Alicante
city: Hospitalet De Llobregat
country: Spain
facility: Pfizer Investigational Site
state: Barcelona/ Spain
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Málaga
country: Spain
facility: Pfizer Investigational Site
city: Malmö
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
city: Derby
country: United Kingdom
facility: Pfizer Investigational Site
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
city: Norwich
country: United Kingdom
facility: Pfizer Investigational Site
city: Southampton
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Warwick D, Arner M, Pajardi G, Reichert B, Szabo Z, Masmejean EH, Fores J, Chapman DS, Gerber RA, Huard F, Seghouani A, Szczypa PP; POINT X Investigators. Collagenase clostridium histolyticum in patients with Dupuytren's contracture: results from POINT X, an open-label study of clinical and patient-reported outcomes. J Hand Surg Eur Vol. 2015 Feb;40(2):124-32. doi: 10.1177/1753193413519926. Epub 2014 Jan 26.