RecruitingPhase 3NCT07371572

The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis

The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis - the IMHOA Trial


Sponsor

Sint Maartenskliniek

Enrollment

212 participants

Start Date

Oct 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to determine the efficacy and safety of intramuscular methylprednisolone in patients with hand osteoarthritis. The main question it aims to answer is what the difference is in hand pain 4 weeks after the first injection with methylplrednisolone. This main goal will be assessed in the first 16 weeks, the RCT phase. Researchers will compare 120mg methylprednisolone with 40mg methylprednisolone and placebo to see if there is a difference in hand pain after 4 weeks. Participants will be asked to visit the hospital for: * injection of the study material * ultrasound assessment * physical examination like joint assessments and grip strenght * examination of blood * x-ray of the hand In phase 2, from week 16 to 48, an open label phase focusing on treatment strategy and safety. In this phase all participants may receive intramuscular methylprednisolone on demand at the dosage of 120mg only if they fulfil the following conditions: hand pain \> 30mm on a VAS (0-100mm) and a minimum of 16 weeks interval between two consecutive injections. Therefore, a maximum of two injections could be received during this period. Irrespective of that, all participants will be followed-up until week 48 when the end-of-study visit will take place.


Eligibility

Min Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 120mg methylprednisolone acetate, a drug called 40mg methylprednisolone acetate, and others for people with hand osteoarthritis. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG120mg methylprednisolone acetate

One single intramuscular injection with 120mg methylprednisolone will be administered at baseline to each participant in the first phase. During the second phase, participants may receive intramuscular methylprednisolone on demand at the dosage of 120mg only if they fulfil the following conditions: hand pain \>30mm on a VAS (0-100mm) and a minimum of 16 weeks interval between two consecutive injections.

DRUG40mg methylprednisolone acetate

One single intramuscular injection with 40mg methylprednisolone will be administered at baseline to each participant in the first phase.

DRUGPlacebo

One single intramuscular injection of placebo (NaCl 0.9%) will be administered at baseline to each participant in this phase.


Locations(1)

Sint Maartenskliniek

Ubbergen, Gelderland, Netherlands

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NCT07371572


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