The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis (NCT07371572) | Clinical Trial Compass
RecruitingPhase 3
The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis
Netherlands212 participantsStarted 2025-10-28
Plain-language 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.
Who can participate
Age range
16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* Not able to read or write the Dutch language
* Neurological diagnosis
* Epilepsy
* Risk of psychiatric d…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy of intramuscular methylprednisolone acetate in reducing hand pain between baseline and week 4, compared to placebo measured on a 0-100 mm Visual Analogue Scale