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Tests treatment safety and results for Hand Osteoarthritis
Official title The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis
ClinicalTrials.gov ID: NCT07371572
What this study is testing
What is 120mg methylprednisolone acetate?
120mg methylprednisolone acetate is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for hand osteoarthritis.
Also referred to as Depo-medrol, Medrol Acetate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Patients with interphalangeal hand OA (according to the EULAR classification criteria 2023) based on patient report (age, morning stiffness) and...
- 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...
You likely can't join if
- Comorbidity
- Chronic inflammatory (rheumatic) diseases
- Infectious diseases
- Known Osteoporosis
- Known Diabetes
- Previous diagnosis of fibromyalgia
See the full eligibility 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...
- 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)
- 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...
- 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 disorder
The study team makes the final eligibility decision.
Where it's taking place
- Ubbergen, Gelderland, Netherlands
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, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ubbergen, Gelderland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.