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

Official title

The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis - the IMHOA Trial

Overview

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.

Interventions

• Drug 120mg methylprednisolone acetate
  One single intramuscular injection with 120mg methylprednisolone will be administered at baseline to each participant in the first phase. During the second phase, 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.
• Drug 40mg methylprednisolone acetate
  One single intramuscular injection with 40mg methylprednisolone will be administered at baseline to each participant in the first phase.
• Drug Placebo
  One single intramuscular injection of placebo (NaCl 0.9%) will be administered at baseline to each participant in this phase.

Primary outcome measures

• 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 [Time frame: From baseline to week 4]

Secondary outcome measures (12)

• Non-inferiority of 40mg compared to 120mg MP of the efficacy of intramuscular methylprednisolone acetate in reducing hand pain assessed by the digital 0-100 mm Visual Analogue Scale [Time frame: From baseline to week 4]
• Change in hand pain at week 4, and thereafter every 4 weeks [Time frame: From week 8 to week 48]
• Percentage of participants with a reduction in hand pain larger than the MCID [Time frame: From baseline to week 4]
• Hand function, change in functional index [Time frame: From baseline to week 48]
• OMERACT-OARSI responder criteria based on pain measured with Visual Analogue Scale [Time frame: From baseline to week 48]
• OMERACT-OARSI responder criteria based on Visual Analogue Scale hand function [Time frame: From baseline to week 48]
• OMERACT-OARSI responder criteria based on patient global assessment measured with Visual Analogue Scale [Time frame: From baseline to week 48]
• Quality of life, measured with EuroQuol-5D-5L [Time frame: From baseline to week 48]
• Patient experience of steroid use with the Steroid PRO [Time frame: From baseline to week 48]
• Changes in local inflammation of hand joints, determined with ultrasound [Time frame: From baseline to week 4]
• Structural changes based on X-ray of the hands [Time frame: From baseline to week 48]
• Effect on joints based on swollen joint count and tender joint count [Time frame: From baseline to week 48]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Netherlands · 1 center

• Sint Maartenskliniek — Ubbergen

Identifiers

NCT: NCT07371572 · 2025.03 · 2024-518344-20-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗