Topical Clobetasol Propionate for Inflammatory Hand Osteoarthritis

Ki vehet részt

• To be eligible for enrollment, an individual must meet all of the following 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
• Informed written consent
• Prior treatment failure (inadequate response or intolerance to at least 1 recommended treatment among paracetamol, topical or oral NSAIDs, or short course of corticosteroids)
• Patient affiliated to a social security scheme

Ki nem vehet részt

• Use of oral, intramuscular or intra-articular or intravenous steroids, other anti-synovial agents (e.g. slow-acting anti-rheumatic drugs such as methotrexate, sulfasalazine), intra-articular hyaluronic acid to the hand joints within the 1 month prior to the inclusion visit (W0)
• Any topical treatment (corticosteroids included) on treated extremities for any indication, other than cosmetic use of creams and lotions, within the 2 weeks prior to the inclusion visit (W0)
• Any new hand OA treatment within the 2 months prior to the inclusion visit (W0), including physiotherapy and provision of new hand splint
• Use of opioids within the 4 weeks (or the equivalent of 5 half-lives) prior to the inclusion visit (W0)
• Planned hand surgery in the next 6 weeks
• Use of any investigational (unlicensed) drug within the 3 months prior to the inclusion visit (W0)
• Presence of a serious, uncontrolled concomitant cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, neurological (including epilepsy) condition which, according to the investigator, makes the patient ineligible for the study
• Patient is unable to apply the study drug on hands
• Participation in another interventional study or being in the exclusion period at the end of a previous study
• Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
• Current skin abnormality, irritation, or lesions of the hands (e.g., eczema, urticarial lesion, skin infection) contraindicating topical application
• Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
• History of glaucoma contraindicating the use of corticosteroids
• Systemic progressive infection
• Patients will be excluded from participating in the study if they meet or are expected to meet any of the following criteria
• Isolated or predominant painful thumb-base OA (i.e., rhizarthrosis)
• Contraindication to propionate clobetasol
• Fibromyalgia
• Use of oral NSAIDs or paracetamol less than 48h before the inclusion visit (W0)
• Pregnant or breastfeeding woman
• Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
• Patient on AME (state medical aid)