Overview
Sponsor-declared trial summary
Dupuytren's contracture
To determine, which treatment strategy 1) primary PNF followed by surgical LF in patients who do not respond to PNF, 2) primary CCH followed by surgical LF in patients who do not respond to CCH or 3) LF as the primary (and secondary) treatment modality is the most efficacious and cost-effective in treating DC in 5-year…
Key facts
- Sponsor
- Pirkanmaan hyvinvointialue
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Musculoskeletal Diseases [C05]
- Trial duration
- 15 Sep 2017 → ongoing
- Decision date (initial)
- 2024-09-03
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-515110-40-00
- EudraCT number
- 2016-005215-41
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To determine, which treatment strategy 1) primary PNF followed by surgical LF in patients who do not respond to PNF, 2) primary CCH followed by surgical LF in patients who do not respond to CCH or 3) LF as the primary (and secondary) treatment modality is the most efficacious and cost-effective in treating DC in 5-year follow-up.
Secondary objectives 1
- To compare the clinical outcomes of the three treatment strategies (main objective) in DC at 3 months, 2 years, 5 years and 10 years
Conditions and MedDRA coding
Dupuytren's contracture
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1) patients with at least 20° combined extension deficit in metacarpophalangeal joint (MP) and/or proximal interphalangeal joint (PIP) in finger/fingers II-V 2) age > 18 years 3) palpable cord 4) provision of informed consent 5) ability to fill the Finnish versions of questionnaires
Exclusion criteria 1
- 1) recurrent contracture in the finger to be treated 2) neurologic condition causing the loss of function of the finger to be treated 3) contraindication for collagenase clostridium histolyticym (Xiapex/Xiaflex ®) 4) pregnant or breast feeding 5) TPED > 135° (Tubiana stage 472) in finger to be treated 6) rheumatoid arthritis 7) previous fracture in finger to be treated, which affects range of motion of MP or PIP joint 8) age > 80 years
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Success at five years
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB13443MIG · Substance
- Active substance
- Collagenase
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 0.9 mg milligram(s)
- Max total dose
- 2.7 mg milligram(s)
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Pirkanmaan hyvinvointialue
- Sponsor organisation
- Pirkanmaan hyvinvointialue
- Address
- Elamanaukio 2
- City
- Tampere
- Postcode
- 33520
- Country
- Finland
Scientific contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Olli Leppänen
Public contact point
- Organisation
- Pirkanmaan hyvinvointialue
- Contact name
- Olli Leppänen
Locations
1 EU/EEA country · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Ongoing, recruitment ended | 50 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Finland | 2017-09-15 | 2017-09-15 | 2024-09-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT 2024-515110-40-00 07Jul2025 CLEAN | 6.3 |
| Recruitment arrangements (for publication) | Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | Liite tiedotteeseen_GDPR_2020-03-24 | 1 |
| Subject information and informed consent form (for publication) | Potilastiedote ja suostumus_09-12-2019 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC_Xiapex | 1 |
| Synopsis of the protocol (for publication) | Tutkimussuunnitelma_DK_lyhennelma | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-19 | Finland | Acceptable with conditions 2024-08-30
|
2024-09-03 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-07-07 | Finland | Acceptable 2025-08-18
|
2025-08-18 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-04-16 | Finland | Acceptable | 2026-05-18 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-20 | Finland | Acceptable 2025-08-18
|
2026-05-20 |