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

NCT07371572 | Recruiting Phase 3 DMC

• 2 other identifiers: 2025.032024-518344-20-00
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

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

Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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

  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 Visual Analogue Scale ranging from 1-100 mm. The higher the score, the worse the outcome.

  From baseline to week 4

Secondary Outcomes (25)

• 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

  From baseline to week 4

• Change in hand pain at week 4, and thereafter every 4 weeks

  From week 8 to week 48

• Percentage of participants with a reduction in hand pain larger than the MCID

  From baseline to week 4

• Hand function, change in functional index

  From baseline to week 48

• OMERACT-OARSI responder criteria based on pain measured with Visual Analogue Scale

  From baseline to week 48

Study Arms (3)

120mg

EXPERIMENTAL

120mg methylprednisolone acetate (3ml)

Drug: 120mg methylprednisolone acetate

40mg

EXPERIMENTAL

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

Drug: 40mg methylprednisolone acetate

Placebo

PLACEBO COMPARATOR

Placebo (3ml NaCl 0.9%)

Drug: Placebo

Interventions

Placebo DRUG

One single intramuscular injection of placebo (NaCl 0.9%) will be administered at baseline to each participant in this phase.

Also known as: 0.9% NaCl, sodium chloride 0.9%

Placebo

120mg methylprednisolone acetate DRUG

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.

Also known as: Depo-medrol, Medrol Acetate, Depo-Medrone

120mg

40mg methylprednisolone acetate DRUG

One single intramuscular injection with 40mg methylprednisolone will be administered at baseline to each participant in the first phase.

Also known as: Medrol Acetate, Depo-Medron, Depo-Medrol

40mg

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sint Maartenskliniek: lead
• ZonMw: The Netherlands Organisation for Health Research and Development: collaborator

Study Sites (1)

Sint Maartenskliniek

Ubbergen, Gelderland, 6574 NA, Netherlands

RECRUITING

MeSH Terms

Interventions

Methylprednisolone Acetate; Methylprednisolone; Saline Solution; Sodium Chloride

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Calin Popa, Dr.

CONTACT

0243659276; c.popa@maartenskliniek.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first phase of the trial will include a parallel interventional study model. In the second phase, all participants will receive the same intervention (120mg methylprednisolone) on demand, which will explain as the single group model.

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: January 28, 2026
• Study Start: October 28, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 28, 2026

Record last verified: 2025-09

Locations

NL (1)