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The efficacy and safety of Intramuscular Methylprednisolone in patients with Hand OsteoArthritis: the IMHOA trial
EU CTIS ID: 2024-518344-20-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with interphalangeal hand OA (according to the classification criteria 2023 (1), see Figure 2 Protocol) 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 ≥ 45 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 parace-tamol)
You likely can't join if
- Comorbidity o Chronic inflammatory (rheumatic) diseases o Infectious diseases o Known Osteoporosis o Known Diabetes o Previous diagnosis of fibromyalgia o Known myasthenia gravis
- Previous surgical interventions on the hand (e.g. carpal tunnel syndrome, etc.)
- Use of other Medication: o Use of immune-modulating medication (including any form of glucocorticoids admin-istered in the previous 16 weeks before inclusion) o Vaccines, alive or attenuated live, inactivated bacterial vaccines (2 weeks before or after inclusion) o Anticoagulants o Enzyme inducing medication such as carbamazepine, phenobarbital, phenytoin and rifampicin o Cyclophosphamide and tacrolimus o (Fos)aprepitant o Ciclosporin
- Patients with a contraindication for MP o Current Gastric and duodenal ulcers o Current infections o Liver cirrhosis o Pregnant or breastfeeding o Known non-response or intolerance for MP
- Not able to read or write the Dutch language
- Neurological diagnosis o Epilepsy o Risk of psychiatric disorder
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.