Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ended
Participants planned
30
Countries
1
Sites
1
Dupuytren Disease
To investigate whether the use of an anti-TNF can improve clinical results of needle fasciotomy for Dupuytren disease
Key facts
- Sponsor
- UZ Leuven
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 16 Oct 2023 → 19 Jan 2026
- Decision date (initial)
- 2023-07-05
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Safety, Efficacy
To investigate whether the use of an anti-TNF can improve clinical results of needle fasciotomy for Dupuytren disease
Secondary objectives 1
- To investigate whether the use of an anti-TNF can reduce the recurrence rate after fasciotomy.
Conditions and MedDRA coding
Dupuytren Disease
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- Patients of 18 years old or older, diagnosed with Dupuytren disease
- Patients eligible for fasciotomy
- Patients with compound MCP/PIP joint contractures (not fixed)
- Patients with a diathesis score of at least 4
Exclusion criteria 21
- Participant has a history of surgery on the same finger (recurrence)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate, highly effective contraceptive. This will be checked by anamnesis. (But most patients are male and older than 50)
- Participation in an interventional Trial with an investigational medicinal product (IMP) or device
- Patients under the age of 18
- Patients with fixed MCP/PIP joint contractures
- Patients with cognitive impairments, severe rheumatic disease and neurological disorders leading to flexion deformities of the fingers
- Being treated with concomitant biologic DMARDS
- Known allergy to tetracaine, lidocaine or prilocaine
- Contra-indication for treatment with Adalimumab or known allergy to this product
- Patients with active or chronic, systemic or localised infections
- Patients with impaired lung functions (including chronic obstructive pulmonary disease (COPD), pneumonia, fibrosis
- Patients with active tuberculosis or other severe infections such as sepsis and opportunistic infections (including pneumonia, pyelonephritis, septic arthritis and septicaemia)
- Patients who have been exposed to tuberculosis* or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis
- Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class III/IV)
- Known history of, or active Hepatitis B infection
- Presence of preexisting or recent-onset central or peripheral nervous system demyelinating disorders (including Multiple Sclerosis, optic neurotos and Guillain-Barré Syndrome)
- Prior or active malignancies
- Patients with ulcerative colitis
- Patients with pancytopenia including aplastic anaemia
- Active or prior documented autoimmune diseases
- Administration of any live vaccine within 5 months prior to planned start of study treatment and within 5 months after study treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Obtain a minimum increase of 10° correction of the finger extension lack in the treatment group versus the placebo.
Secondary endpoints 4
- Recurrence Rate
- QuickDASH
- Pain score: Visual Analogue Scale
- Patient satisfaction: Visual Analogue Scale
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB20016 · Substance
- Active substance
- Adalimumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
SUB20722 · Substance
- Active substance
- Saline
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 1000 ml millilitre(s)
- Max total dose
- 1000 ml millilitre(s)
- Max treatment duration
- 365 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
UZ Leuven
- Sponsor organisation
- UZ Leuven
- Address
- Herestraat 49
- City
- Leuven
- Postcode
- 3000
- Country
- Belgium
Scientific contact point
- Organisation
- UZ Leuven
- Contact name
- Ilse Degreef
Public contact point
- Organisation
- UZ Leuven
- Contact name
- Ilse Degreef
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ended | 30 | 1 |
| 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 |
|---|---|---|---|---|---|
| Belgium | 2023-10-16 | 2026-01-19 | 2023-11-06 | 2025-01-14 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-03-17 | Belgium | Acceptable with conditions 2023-07-05
|
2023-07-05 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-08-02 | Belgium | Acceptable 2023-09-08
|
2023-09-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2023-10-27 | Belgium | Acceptable 2023-12-13
|
2023-12-15 |