2025-520678-20-00招募中3 期
Topical Clobetasol Propionate for Inflammatory Hand osteoarthritis: A randomized trial versus placebo.(PROCLAME)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 187
- 试验地点
- 15
- 主要终点
- 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?”.
研究概览
简要总结
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
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Isolated or predominant painful thumb-base OA (i.e., rhizarthrosis)
- •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).
- •History of glaucoma contraindicating the use of corticosteroids.
- •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.
- •Systemic progressive infection
- •Pregnant or breastfeeding woman
- •Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom
- •Patient is unable to apply the study drug on hands
- •Other inflammatory joint disease (e.g. gout, reactive arthritis, rheumatoid arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease)
- •Participation in another interventional study or being in the exclusion period at the end of a previous study.
- •Patient on AME (state medical aid)
- •Current skin abnormality, irritation, or lesions of the hands (e.g., eczema, urticarial lesion, skin infection) contraindicating topical application
- •Contraindication to propionate clobetasol
- •Existence of a pain syndrome of the upper limbs, which would interfere with the monitoring of pain
- •Fibromyalgia
- •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)
- •Use of oral NSAIDs or paracetamol less than 48h before 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).
研究组 & 干预措施
Placebo de formule développée spécifiquement pour la recherche par la PUI (cf IMPD-Q)
Placebo
干预措施: Placebo de formule développée spécifiquement pour la recherche par la PUI (cf IMPD-Q) (Drug)
CLOBETASOL PROPIONATE
Test
干预措施: CLOBETASOL PROPIONATE (Drug)
结局指标
主要结局
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?”.
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?”.
次要结局
- 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 index score, EQ-5D-5L Global health status
研究者
Dr Alice COURTIES
Scientific
Assistance Publique Hopitaux De Paris
研究点 (15)
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