The efficacy and safety of Intramuscular Methylprednisolone in patients with Hand OsteoArthritis: the IMHOA trial

Conditions

Hand osteoarthritis

Brief summary

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).

Detailed description

Evaluate the non-inferiority of 40mg MP compared to 120mg MP, provided both doses demonstrate superiority over placebo., 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., Assessments based on patient-reported outcomes, structural joint changes via imaging, and inflammatory biomarkers., The exploration of predictors of treatment response, subgroup variations based on radiographic findings, and safety outcomes using standardized criteria., The efficacy and safety of MP will be analysed concerning cumulative dose and circulating biomarkers.

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Interventions

DRUGDepo-Medrol 40 mg/ml

DRUGsuspensie voor injectie

DRUGNatriumchloride 0

DRUG9% oplossing voor injectie

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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).	—

Secondary

Measure	Time frame
Evaluate the non-inferiority of 40mg MP compared to 120mg MP, provided both doses demonstrate superiority over placebo., 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., Assessments based on patient-reported outcomes, structural joint changes via imaging, and inflammatory biomarkers., The exploration of predictors of treatment response, subgroup variations based on radiographic findings, and safety outcomes using standardized criteria., The efficacy and safety of MP will be analysed concerning cumulative dose and circulating biomarkers.	—

Measure

Time frame

Evaluate the non-inferiority of 40mg MP compared to 120mg MP, provided both doses demonstrate superiority over placebo., 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., Assessments based on patient-reported outcomes, structural joint changes via imaging, and inflammatory biomarkers., The exploration of predictors of treatment response, subgroup variations based on radiographic findings, and safety outcomes using standardized criteria., The efficacy and safety of MP will be analysed concerning cumulative dose and circulating biomarkers.

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Countries

Netherlands

Outcome results

None listed