The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis (IMHOA)

Sint Maartenskliniek

Status and phase: Enrolling; Phase 3

Conditions: Hand Osteoarthritis

Treatments: Drug: 40mg methylprednisolone acetate; Drug: Placebo; Drug: 120mg methylprednisolone acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT07371572

2025.03

2024-518344-20-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment: 212 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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 disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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212 participants in 3 patient groups, including a placebo group

120mg

Experimental group

Description:

120mg methylprednisolone acetate (3ml)

Treatment:

Drug: 120mg methylprednisolone acetate

40mg

Experimental group

Description:

40mg methylprednisolone acetate (1ml + 2 ml NaCl 0.9%)

Treatment:

Drug: 40mg methylprednisolone acetate

Placebo

Placebo Comparator group

Description:

Placebo (3ml NaCl 0.9%)

Treatment:

Drug: Placebo