Clinical trial • Phase III • Musculoskeletal|Dermatology

COLLAGENASE for Dupuytren's contracture

Phase III trial of COLLAGENASE for Dupuytren's contracture.

Overview

Trial Therapeutic Area
Musculoskeletal|Dermatology
Trial Disease
Dupuytren's contracture
Trial Stage
Phase III
Drug Modality
Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
19-08-2024
First CTIS Authorization Date
03-09-2024

Trial design

Randomised, open-label, three-arm parallel randomized comparison: collagenase clostridium histolyticum (collagenase) injection versus percutaneous needle fasciotomy (pnf) versus limited fasciectomy (lf). (dosing/schedule not specified in ctis record; product metadata lists max daily dose 0.9 mg and max total 2.7 mg for collagenase.)-controlled Phase III trial across 6 sites in Finland.

Randomised
Yes
Open Label
Yes
Comparator
Three-arm parallel randomized comparison: collagenase clostridium histolyticum (COLLAGENASE) injection versus percutaneous needle fasciotomy (PNF) versus limited fasciectomy (LF). (Dosing/schedule not specified in CTIS record; product metadata lists max daily dose 0.9 mg and max total 2.7 mg for COLLAGENASE.)
Target Sample Size
50
Trial Duration For Participant
1825

Eligibility

Recruits 50 No vulnerable population selected. Participants must provide informed consent (inclusion criterion: 'provision of informed consent') and be able to complete Finnish versions of questionnaires; no assent or parental consent procedures for minors are described (age > 18 years required)..

Pregnancy Exclusion
4) pregnant or breast feeding
Vulnerable Population
No vulnerable population selected. Participants must provide informed consent (inclusion criterion: 'provision of informed consent') and be able to complete Finnish versions of questionnaires; no assent or parental consent procedures for minors are described (age > 18 years required).

Inclusion criteria

  • {"criterion_text":"- 1) patients with at least 20° combined extension deficit in metacarpophalangeal joint (MP) and/or proximal interphalangeal joint (PIP) in finger/fingers II-V\n- 2) age > 18 years\n- 3) palpable cord\n- 4) provision of informed consent\n- 5) ability to fill the Finnish versions of questionnaires"}

Exclusion criteria

  • {"criterion_text":"- 1) recurrent contracture in the finger to be treated\n- 2) neurologic condition causing the loss of function of the finger to be treated\n- 3) contraindication for collagenase clostridium histolyticym (Xiapex/Xiaflex ®)\n- 4) pregnant or breast feeding\n- 5) TPED > 135° (Tubiana stage 472) in finger to be treated\n- 6) rheumatoid arthritis\n- 7) previous fracture in finger to be treated, which affects range of motion of MP or PIP joint\n- 8) age > 80 years"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Success at five years","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
50
Recruitment Window Months
183
Consent Approach
Participants must provide informed consent ('provision of informed consent'). Subject information and informed consent form documents are present (including Finnish-language material, e.g. 'Potilastiedote ja suostumus_09-12-2019'); participants must be able to complete Finnish versions of questionnaires. No assent/parental consent procedures are described (study requires age > 18 years).

Geography

Total Number Of Sites
6
Total Number Of Participants
50

Finland

Earliest CTIS Part Ii Submission Date
13-06-2024
Latest Decision Or Authorization Date
03-09-2024
Processing Time Days
82
Number Of Sites
6
Number Of Participants
50

Sites

Site Name
Central Finland Hospital District Central Finland Hospital Nova
Department Name
Department of Hand Surgery
Contact Person Name
Teemu Karjalainen
Contact Person Email
teemu.karjalainen@hyvaks.fi
Site Name
HUS-Yhtymae
Department Name
Department of Hand Surgery
Contact Person Name
Susanna Stjernberg-Salmela
Site Name
Turku University Hospital
Department Name
Department of Hand Surgery
Contact Person Name
Markus Pääkkönen
Contact Person Email
markus.paakkonen@varha.fi
Site Name
Oulu University Hospital
Department Name
Department of Hand Surgery
Contact Person Name
Janne Soikkeli
Contact Person Email
janne.soikkeli@varha.fi
Site Name
Tampere University Hospital
Department Name
Department of Hand Surgery
Contact Person Name
Olli Leppänen
Contact Person Email
olli.leppanen@pirha.fi
Site Name
Kuopio University Hospital
Department Name
Department of Hand Surgery
Contact Person Name
Matti Juntunen

Sponsor

Primary sponsor

Full Name
Pirkanmaan hyvinvointialue
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Finland

Investigational products

Investigational Product Name
COLLAGENASE
Active Substance
COLLAGENASE
Modality
Peptide/protein/enzyme
Routes Of Administration
INJECTION
Route
INJECTION
Authorisation Status
Authorised
Maximum Dose
Max daily 0.9 mg; max total 2.7 mg

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