The efficacy and safety of Intramuscular Methylprednisolone in patients with Hand OsteoArthritis: the IMHOA trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sint Maartenskliniek Stichting

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

28 Oct 2025 → ongoing

Decision date (initial)

2025-09-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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 100mm Visual Analogue Scale (VAS).

Secondary objectives 8

1. Investigate non-inferiority of 40mg MP compared to 120mg MP (in case superiority to placebo of both interventions is proven in the primary analysis).
2. Compare the three treatment arms based on: • Change in hand pain at week 8, and thereafter every 4 weeks until week 48 (VAS, 0-100mm) • Percentage of participants with a reduction in hand pain larger than the minimal clinically important difference in pain (MCID) = 10 mm • 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 (MHQ). • Grip strength, measured with a dynamometer at week 4, 16, 48. • OMERACT-OARSI responder criteria based on VAS pain, VAS hand function and Patient Global Assessment (PGA). Proportion participants fulfilling responder criteria every 4 weeks compared to baseline. • Quality of Life, measured with EuroQuol-5D-5L questionnaire at week 16, 32 and 48. • Patient experience of steroid use with the Steroid Pro questionnaire every 4 weeks. • Patient experience of steroid use and hand function with the MD-HAQ questionnaire every 4 weeks. • Changes in local inflammation of the hand joints, determined with Ultrasound (US). US of hands to assess change in DIP/PIP joints at week 4 compared to baseline with change in PD and Greyscale score. • Structural changes based on X-ray of the hands to determine joint space narrowing, erosive or non-erosive, DIP/PIP joints and osteophytes between baseline and 48 weeks follow-up. • Effect on affected joints based on swollen joint count (SJC) and tender joint count (TJC) at baseline, week 4 and week 48. • Changes of systemic inflammation assessed by CRP and ESR at week 4, 16, and 48 compared to baseline. • Medication use, health care use and costs by using iPCQ and iMCQ.
3. Explore association of baseline values with treatment response (OMERACT-OARSI response criteria) and develop a prediction model.
4. Explore subgroups according to structural changes on X-ray of the hand based on erosive or non-erosive, osteophytes, DIP/PIP joints, joint space narrowing at baseline.
5. Assess the safety of methylprednisolone 120mg or 40mg compared to placebo by assessing incidence density and cumulative incidence of all AEs and SAEs and (S)AEs related to glucocorticoid use for each phase, using the Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) and using the Glucocorticoid Toxicity Index (GTI) light.
6. Evaluate efficacy and safety of methylprednisolone on endpoints mentioned under 2 and 3, comparing participants based on the cumulative dose of MP received during the study period.
7. Explore subgroup differences categorized by demographic factors, X-ray, ultrasound and biomarkers in blood.
8. Identification of circulating biomarkers associated with response to MP.

Conditions and MedDRA coding

Hand osteoarthritis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patients with interphalangeal hand OA (according to the classification criteria 2023 (1), see Figure 2 Protocol) 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)).
2. Age ≥ 45 years
3. Have hand pain >40mm on a 100mm visual analogue scale (VAS)
4. 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 parace-tamol)

Exclusion criteria 6

1. Comorbidity o Chronic inflammatory (rheumatic) diseases o Infectious diseases o Known Osteoporosis o Known Diabetes o Previous diagnosis of fibromyalgia o Known myasthenia gravis
2. Previous surgical interventions on the hand (e.g. carpal tunnel syndrome, etc.)
3. Use of other Medication: o Use of immune-modulating medication (including any form of glucocorticoids admin-istered in the previous 16 weeks before inclusion) o Vaccines, alive or attenuated live, inactivated bacterial vaccines (2 weeks before or after inclusion) o Anticoagulants o Enzyme inducing medication such as carbamazepine, phenobarbital, phenytoin and rifampicin o Cyclophosphamide and tacrolimus o (Fos)aprepitant o Ciclosporin
4. Patients with a contraindication for MP o Current Gastric and duodenal ulcers o Current infections o Liver cirrhosis o Pregnant or breastfeeding o Known non-response or intolerance for MP
5. Not able to read or write the Dutch language
6. Neurological diagnosis o Epilepsy o Risk of psychiatric disorder

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 100mm Visual Analogue Scale (VAS).

Secondary endpoints 5

1. Evaluate the non-inferiority of 40mg MP compared to 120mg MP, provided both doses demonstrate superiority over placebo.
2. Compare the three treatment arms based on hand pain reduction, functional improvement, grip strength, quality of life, and systemic/local inflammation changes over 48 weeks.
3. Assessments based on patient-reported outcomes, structural joint changes via imaging, and inflammatory biomarkers.
4. The exploration of predictors of treatment response, subgroup variations based on radiographic findings, and safety outcomes using standardized criteria.
5. The efficacy and safety of MP will be analysed concerning cumulative dose and circulating biomarkers.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sint Maartenskliniek Stichting

Sponsor organisation

Sint Maartenskliniek Stichting

Address

Hengstdal 3

City

Ubbergen

Postcode

6574 NA

Country

Netherlands

Scientific contact point

Organisation

Sint Maartenskliniek Stichting

Contact name

Nienke Ponsteen

Public contact point

Organisation

Sint Maartenskliniek Stichting

Contact name

Nienke Ponsteen

Locations

1 EU/EEA country · 3 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications