Actively Recruiting

Phase 3
Age: 16Years +
All Genders
NCT07371572

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

Led by Sint Maartenskliniek · Updated on 2026-01-28

212

Participants Needed

1

Research Sites

157 weeks

Total Duration

On this page

Sponsors

S

Sint Maartenskliniek

Lead Sponsor

Z

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with interphalangeal hand osteoarthritis based on EULAR criteria and radiographs less than 6 months old
  • Age 16 years or older
  • Hand pain greater than 40mm on a 100mm visual analogue scale
  • Previous failure of at least one conventional pain medication (excluding paracetamol)
Not Eligible

You will not qualify if you...

  • Chronic inflammatory rheumatic diseases
  • Infectious diseases
  • Known osteoporosis
  • Known diabetes
  • Previous diagnosis of fibromyalgia
  • Known myasthenia gravis
  • Previous surgical interventions on the hand
  • Contraindications for methylprednisolone including current gastric or duodenal ulcers, current infections, liver cirrhosis, pregnancy or breastfeeding, known non-response or intolerance
  • Use of interacting medications as per Dutch Medication Surveillance System
  • Unable to read or write Dutch
  • Neurological diagnoses including epilepsy or risk of psychiatric disorder

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sint Maartenskliniek

Ubbergen, Gelderland, Netherlands, 6574 NA

Actively Recruiting

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Research Team

C

Calin Popa, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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