The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis
Key facts
- Where
- Apeldoorn, Leiden, and Ubbergen, NetherlandsSee the 3 sites
- Phase
- Phase 3
Where in Netherlands
- Gelre HospitalsApeldoorn, NetherlandsTaking people
- Leids Universitair Medisch Centrum (LUMC)Leiden, NetherlandsTaking people
- Sint Maartenskliniek StichtingUbbergen, NetherlandsTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Sint Maartenskliniek
- Trial code
- NCT07371572EU 2024-518344-20-00
- Record updated
- 28 January 2026
- Original description
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.Read full original descriptionShow less
The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis - the IMHOA Trial
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.
Inclusion: Patients with interphalangeal hand OA (according to the EULAR classification criteria 2023) 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)); Age ≥ 16 years; Have hand pain >40mm on a 100mm visual analogue scale (VAS); 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 paracetamol).
Exclusion: Comorbidity; Chronic inflammatory (rheumatic) diseases; Infectious diseases; Known Osteoporosis; Known Diabetes; Previous diagnosis of fibromyalgia; Known myasthenia gravis; Previous surgical interventions on the hand (e.g. carpal tunnel syndrome, etc.); Use of other Medication: In order to maximize the generalizability of the study interactions between methylprednisolone and co-medication is only prohibited when the Dutch Medication Surveillance System (Z-index) gives a signal for this interaction; Patients with a contraindication for MP; Current Gastric and duodenal ulcers; Current infections; Liver cirrhosis; Pregnant or breastfeeding; Known non-response or intolerance for MP; Neurological diagnosis; Epilepsy; Risk of psychiatric disorder; Not able to read or write the Dutch language.