Topical Clobetasol Propionate for Inflammatory Hand osteoarthritis: A randomized trial versus placebo.(PROCLAME)

INTERVENTION: Product Name: Placebo de formule développée spécifiquement pour la recherche par la PUI (cf IMPD‐Q), Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A , Product Name: CLOBETASOL PROPIONATE, Product Code:SUB01346MIG, Pharmaceutical Form: CREAM, Other descriptive name: , Strength: CONDITION: Adult patients with symptomatic and inflammatory Hand osteoarthritis HOA. ; MedDRA version: 21.1Level: LLTClassification code: 10019115Term: Hand osteoarthritis Class: 10028395 ; MedDRA version: 20.0Level: SOCClassification code: 10028395Term: Musculoskeletal and connective tissue disorders Class: 17 Therapeutic area: Diseases [C] ‐ Musculoskeletal Diseases [C05] PRIMARY OUTCOME: Main Objective: To compare the efficacy on pain intensity between topical clobetasol propionate 0.05% with a tapering regimen (twice daily for 2 weeks followed by once daily for 2 weeks) versus placebo in patients with inflammatory hand osteoarthritis Primary end point(s): The primary endpoint is the change in pain intensity between W0 and W4 (W4‐W0). Self‐reported hand pain in the previous 48h measured on a 100 mm VAS at W0 and W4. The measurement will be done with the standard question recommended by Osteoarthritis Research Society International (OARSI): “how much pain in your hands did you experience during the last 48h?”. Secondary Objective: To compare topical clobetasol proprionate 0.05% twice a day versus placebo for: Efficacy objectives 1.Hand pain improvement at W4 2.Hand function and stiffness improvement at W4 3.Treatment response at W4 4.Quality of life improvement at W4, To compare topical clobetasol proprionate 0.05% twice a day versus placebo for: Safety and compliance SECONDARY OUTCOME: Secondary end point(s):1.Hand Pain improvement: ‐Change in pain intensity between W0 and W4 (W4‐W0) of AUSCAN pain subscore 2.Hand function and stiffness improvement Change between W0 and W4 (W4‐W0) in the following endpoints 3. Treatment response at W4 ‐Proportion of patients’ responders according to the Patient global impression of change (PGIC) 4.Quality of life improvement ‐Change between W0 and W4 (W4‐W0) in: EQ‐5D‐5L inde Xscore, EQ‐5D‐5L Global health status INCLUSION CRITERIA: •Age = 45 years, •Symptomatic HOA according to the American College of Rheumatology criteria [10], EVA = 40/100 in the last 48 hours, •Presence of hand pain for at least 15 days in the last 30 days, •At least =2 symptomatic IP joint with clinical palpable synovitis at inclusion, •At least =2 IP joint with presence of moderate or major inflammation grey‐scale synovitis (score 2 or 3) and/or Power Doppler signal (score =1) on ultrasound, •Informed written consent, •Patient affiliated to a social security scheme, Prior treatment failure (inadequate response or intolerance to at least 1 recommended treatment among paracetamol, topical or oral NSAIDs, or short course of corticosteroids)