Treatment Of Dupuytren's Contracture With Collagenase Clostridium Histolyticum Injection (Xiapex)

NCT01229436 | Completed Phase 3 Results

• 1 other identifier: B1531002
• Study Type: interventional
• Target: 254
• Locations: 8 countries
• Sites: 28

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).

Conditions

Dupuytren's Contracture

Keywords

Dupuytren's; treatment; injection; recovery; health care resources

Outcome Measures

Primary Outcomes (18)

• Total Passive Extension Deficit (TPED) at Baseline for First Injection

  TPED was defined as the sum of passive extension deficits (PED) in the MP, PIP and distal interphalangeal (DIP) joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for first injection was the TPED value taken closest and prior to the administration of first injection. Baseline value after first injection was also considered as baseline for follow-up on Day 90, 180 after last injection (follow-up baseline). 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Baseline for first injection

• Total Passive Extension Deficit (TPED) at Baseline for Second Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for second injection was the TPED value taken closest and prior to the administration of second injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Baseline for second injection

• Total Passive Extension Deficit (TPED) at Baseline for Third Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for third injection was the TPED value taken closest and prior to the administration of third injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Baseline for third injection

• Total Passive Extension Deficit (TPED) at Baseline for Fourth Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. Baseline value for fourth injection was the TPED value taken closest and prior to the administration of fourth injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Baseline for fourth injection

• Total Passive Extension Deficit (TPED) at Day 1 After First Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 1 after first injection

• Total Passive Extension Deficit (TPED) at Day 7 After First Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 7 after first injection

• Total Passive Extension Deficit (TPED) at Day 30 After First Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after first injection for fingers that received 1 injection. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 30 after first injection

• Total Passive Extension Deficit (TPED) at Day 1 After Second Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 1 after second injection

• Total Passive Extension Deficit (TPED) at Day 7 After Second Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 7 after second injection

• Total Passive Extension Deficit (TPED) at Day 30 After Second Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after second injection for fingers that received 2 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 30 after second injection

• Total Passive Extension Deficit (TPED) at Day 1 After Third Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 1 after third injection

• Total Passive Extension Deficit (TPED) at Day 7 After Third Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 7 after third injection

• Total Passive Extension Deficit (TPED) at Day 30 After Third Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after third injection for fingers that received 3 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 30 after third injection

• Total Passive Extension Deficit (TPED) at Day 1 After Fourth Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 1 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 1 after fourth injection

• Total Passive Extension Deficit (TPED) at Day 7 After Fourth Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 7 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 7 after fourth injection

• Total Passive Extension Deficit (TPED) at Day 30 After Fourth Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 30 after fourth injection for fingers that received 4 injections. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 30 after fourth injection

• Total Passive Extension Deficit (TPED) at Day 90 After Last Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 90 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 90 after last injection

• Total Passive Extension Deficit (TPED) at Day 180 After Last Injection

  TPED was defined as the sum of PED in the MP, PIP and DIP joints. PED was measured using finger goniometry. Passive extension=angle of the joint (MP or PIP or DIP) when the finger was passively extended as far possible toward the normal extension. PED=angle of deficit from normal extension. TPED was reported at Day 180 after the last injection, where last injection was a maximum up to fourth injection for a finger. 'Number of fingers/joints analyzed' signifies total number of fingers/joints that were evaluable for this outcome measure.

  Day 180 after last injection

Secondary Outcomes (14)

• Passive Extension Deficit (PED) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints

  Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up: Day 90, 180 after last injection

• 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

  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

• 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

  Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection

• Range of Motion (ROM) for Metacarpophalangeal (MP) and Proximal Interphalangeal (PIP) Joints

  Baseline for first, second, third injection; Day 1, 7, 30 after first, second, third injection; Follow-up Day 90, 180 after last injection

• Participant Global Assessment of Treatment Satisfaction and Disease Severity

  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

Other Outcomes (3)

• Number of Participants With Clinically Significant Change From Baseline in Vital Signs

  Screening up to Day 180 after last injection

• Number of Participants With Laboratory Abnormalities

  Screening up to Day 180 after last injection

• Number of Participants With Anti-Drug Antibody (ADA)

  Screening, Follow-up Day 180 after last injection

Study Arms (1)

Xiapex Injection

EXPERIMENTAL

Drug: Xiapex

Interventions

Xiapex DRUG

Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol

Xiapex Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (28)

Pfizer Investigational Site

Copenhagen, 1402 K, Denmark

Location

Pfizer Investigational Site

Silkeborg, 8600, Denmark

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Pfizer Investigational Site

Montpellier, 34295, France

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Pfizer Investigational Site

Nice, 06000, France

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Pfizer Investigational Site

Paris, 75016, France

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Pfizer Investigational Site

Paris, Cedex 15 75908, France

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Pfizer Investigational Site

Bad Neustadt an der Saale, 97616, Germany

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Pfizer Investigational Site

Berlin, 10627, Germany

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Pfizer Investigational Site

Bonn, 53123, Germany

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Pfizer Investigational Site

Münster, 48149, Germany

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Pfizer Investigational Site

Nuremberg, 90471, Germany

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Pfizer Investigational Site

Tübingen, 72076, Germany

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Pfizer Investigational Site

Miskolc, 3526, Hungary

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Pfizer Investigational Site

Sesto San Giovanni, Milano, 20099, Italy

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Pfizer Investigational Site

Modena, 41124, Italy

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Pfizer Investigational Site

Savona, 17100, Italy

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Pfizer Investigational Site

Elche, Alicante, 03203, Spain

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Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona/ Spain, 08907, Spain

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Pfizer Investigational Site

Barcelona, Barcelona, 08036, Spain

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Pfizer Investigational Site

Málaga, Málaga, 29010, Spain

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Pfizer Investigational Site

Barcelona, 08022, Spain

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Pfizer Investigational Site

Malmo, SE-205 02, Sweden

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Pfizer Investigational Site

Stockholm, SE 118 83, Sweden

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Pfizer Investigational Site

Uppsala, 751 85, Sweden

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Pfizer Investigational Site

Derby, DE22 3NE, United Kingdom

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Pfizer Investigational Site

Glasgow, G4 0SF, United Kingdom

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Pfizer Investigational Site

Norwich, NR4 7UY, United Kingdom

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Pfizer Investigational Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24470559 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Dupuytren Contracture

Interventions

xiapex

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Contracture; Muscular Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Results were not reported for fifth injection as no finger received 5 injections.Results are reported for 'number of days of concomitant pain medication' as 'amount of pain medication' was interpreted as total number of days with pain medication use.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: October 26, 2010
• First Posted: October 27, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: March 17, 2014
• Results First Posted: March 17, 2014

Record last verified: 2014-01

Locations

HU (1); SE (3); ES (5); IT (3); FR (4); GB (4); DE (6); DK (2)