NCT07371572

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 212 (estimated)
• Sponsor: Sint Maartenskliniek · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hand Osteoarthritis

Interventions

Type	Name	Description
DRUG	120mg 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.
DRUG	40mg methylprednisolone acetate	One single intramuscular injection with 40mg methylprednisolone will be administered at baseline to each participant in the first phase.
DRUG	Placebo	One single intramuscular injection of placebo (NaCl 0.9%) will be administered at baseline to each participant in this phase.

Timeline

• Start date: 2025-10-28
• Primary completion: 2028-04-01
• Completion: 2028-11-01
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: Netherlands