Pilot study RCT anti-TNF Adalimumab versus placebo in fasciotomy Dupuytren contracture

Phase 1

Recruiting

• Conditions: Dupuytren Disease; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: CTIS2023-503701-11-00
• Lead Sponsor: Z Leuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-17
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion 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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether the use of an anti-TNF can improve clinical results of needle fasciotomy for Dupuytren disease;Secondary Objective: To investigate whether the use of an anti-TNF can reduce the recurrence rate after fasciotomy.;Primary end point(s): Obtain a minimum increase of 10° correction of the finger extension lack in the treatment group versus the placebo.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Recurrence Rate;Secondary end point(s):QuickDASH;Secondary end point(s):Pain score: Visual Analogue Scale;Secondary end point(s):Patient satisfaction: Visual Analogue Scale