Methylprednisolone acetate for Hand osteoarthritis

Inclusion criteria

• {"criterion_text":"- Patients with interphalangeal hand OA (according to the classification criteria 2023 (1), see Figure 2 Protocol) based on patient report (age, morning stiffness) and radiographs of ≤6 months old (osteophytes, JSN (joint space narrowing) and symptom-structure concordance (present if majority (≥50%) of the symptomatic joints demonstrate radiographic findings))."}
• {"criterion_text":"- Age ≥ 45 years"}
• {"criterion_text":"- Have hand pain >40mm on a 100mm visual analogue scale (VAS)"}
• {"criterion_text":"- Have previously experienced failure of at least one conventional type of pain medication, (self-reported of insufficient effect from topical or oral NSAID, etc. with exclusion of parace-tamol)"}

Exclusion criteria

• {"criterion_text":"- Comorbidity o Chronic inflammatory (rheumatic) diseases o Infectious diseases o Known Osteoporosis o Known Diabetes o Previous diagnosis of fibromyalgia o Known myasthenia gravis"}
• {"criterion_text":"- Previous surgical interventions on the hand (e.g. carpal tunnel syndrome, etc.)"}
• {"criterion_text":"- Use of other Medication: o Use of immune-modulating medication (including any form of glucocorticoids admin-istered in the previous 16 weeks before inclusion) o Vaccines, alive or attenuated live, inactivated bacterial vaccines (2 weeks before or after inclusion) o Anticoagulants o Enzyme inducing medication such as carbamazepine, phenobarbital, phenytoin and rifampicin o Cyclophosphamide and tacrolimus o (Fos)aprepitant o Ciclosporin"}
• {"criterion_text":"- Patients with a contraindication for MP o Current Gastric and duodenal ulcers o Current infections o Liver cirrhosis o Pregnant or breastfeeding o Known non-response or intolerance for MP"}
• {"criterion_text":"- Not able to read or write the Dutch language"}
• {"criterion_text":"- Neurological diagnosis o Epilepsy o Risk of psychiatric disorder"}

Primary endpoints

• {"endpoint_text":"- The primary objective of this study is to assess the efficacy of intramuscular methylprednisolone acetate (120mg or 40mg) in reducing hand pain between baseline and week 4, compared to placebo measured on a digital 100mm Visual Analogue Scale (VAS).","definition_or_measurement_approach":"Measured as change in hand pain between baseline and week 4 on a digital 100 mm Visual Analogue Scale (VAS)."}

Secondary endpoints

• {"endpoint_text":"- Evaluate the non-inferiority of 40mg MP compared to 120mg MP, provided both doses demonstrate superiority over placebo.","definition_or_measurement_approach":"Non-inferiority comparison between 40 mg and 120 mg methylprednisolone if both doses show superiority to placebo in primary analysis."}
• {"endpoint_text":"- Compare the three treatment arms based on hand pain reduction, functional improvement, grip strength, quality of life, and systemic/local inflammation changes over 48 weeks.","definition_or_measurement_approach":"Multiple measures over 48 weeks including VAS pain at specified weeks, Michigan Hand Outcomes Questionnaire for function, dynamometer for grip strength, EQ-5D-5L for QoL, CRP/ESR and ultrasound/X-ray for inflammation/structure."}
• {"endpoint_text":"- Assessments based on patient-reported outcomes, structural joint changes via imaging, and inflammatory biomarkers.","definition_or_measurement_approach":"Patient-reported questionnaires, imaging (US, X-ray) assessments, and blood biomarkers (e.g., CRP, ESR, circulating biomarkers)."}
• {"endpoint_text":"- The exploration of predictors of treatment response, subgroup variations based on radiographic findings, and safety outcomes using standardized criteria.","definition_or_measurement_approach":"Exploratory analyses including OMERACT-OARSI responder criteria, subgroup analyses by radiographic features, and safety assessed with CTCAEv5 and GTI light."}
• {"endpoint_text":"- The efficacy and safety of MP will be analysed concerning cumulative dose and circulating biomarkers.","definition_or_measurement_approach":"Analysis of efficacy/safety by cumulative MP dose and association with circulating biomarkers."}

Netherlands

Earliest CTIS Part Ii Submission Date

18-08-2025

Latest Decision Or Authorization Date

04-09-2025

Processing Time Days

17

Number Of Sites

1

Number Of Participants

212

Primary sponsor

Full Name

Sint Maartenskliniek Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands