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

ConditionHand Osteoarthritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age16+
SponsorSint Maartenskliniek

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Comorbidity

Chronic inflammatory (rheumatic) diseases

Infectious diseases

Known Osteoporosis

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 40mg methylprednisolone acetate

    Drug

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

  • Placebo

    Drug

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

Treatment groups

212 Participants
are divided into 3 treatment groups
Group A: 120mgExperimental treatment 1 intervention
Group B: 40mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
From baseline to week 4

Secondary outcomes

1

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

Investigate non-inferiority of 40mg MP compared to 120mg MP (in case superiority to placebo of both interventions is proven in the primary analysis) of the efficacy of intramuscular methylprednisolone acetate in reducing hand pain measured on a digital Visual Analogue Scale ranging from 1-100 mm. The higher the score, the worse the outcome.

Time frame
From baseline to week 4
2

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

Compare the three treatment arms based on change in hand pain at week 8, and therafter every 4 weeks until week 48 measured on a digital Visual Analogue Scale ranging from 1-100 mm. The higher the score, the worse the outcome.

Time frame
From week 8 to week 48
3

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

Compare the three treatment arms based on percentage of participants with a reduction in hand pain larger than the minimal clinically important difference in pain (MCID) = 10 mm

Time frame
From baseline to week 4
4

Hand function, change in functional index

Compare the three treatment arms based on hand function. Change in functional index for hand OA at week 4, 16, 32 and 48, compared to baseline measured with Michigan Hand outcomes Questionnaire ranging from 0-100. The higher the score, the better the hand function.

Time frame
From baseline to week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sint Maartenskliniek

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Collaborator

Source ClinicalTrials.gov
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