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Pilot study RCT anti-TNF Adalimumab versus placebo in fasciotomy Dupuytren contracture
EU CTIS ID: 2023-503701-11-00
What this study is testing
To investigate whether the use of an anti-TNF can improve clinical results of needle fasciotomy for Dupuytren disease
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- Participant has a history of surgery on the same finger (recurrence)
- 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)
See the full eligibility criteria
- 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
- Participant has a history of surgery on the same finger (recurrence)
- 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
- 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)
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.