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

NCT07371572 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2026-01-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • ZonMw: The Netherlands Organisation for Health Research and Development

    collaborator OTHER

  • Sint Maartenskliniek

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2028-04-30
Completion
2028-11-30

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07371572 on ClinicalTrials.gov