A Phase 3 interventional study of 120mg methylprednisolone acetate and 40mg methylprednisolone acetate in Hand Osteoarthritis, sponsored by Sint Maartenskliniek. Recruiting at 1 site in Netherlands. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Sint Maartenskliniek · Phase 3, Interventional, and Treatment
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:
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.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 212 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Sint Maartenskliniek is the lead sponsor of 29 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Comorbidity
Patients with a for MP
Neurological diagnosis
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
120mg methylprednisolone acetate (3ml)
Drug: 120mg methylprednisolone acetate
40mg methylprednisolone acetate (1ml + 2 ml NaCl 0.9%)
Drug: 40mg methylprednisolone acetate
Placebo (3ml NaCl 0.9%)
Drug: Placebo
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
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
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%
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
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
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
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
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
OMERACT-OARSI responder criteria based on pain measured with Visual Analogue Scale
Compare the three treatment arms based on OMERACT-OARSI responder criteria based on pain measured on a digital Visual Analogue Scale ranging from 1-100 mm. The higher the score, the worse the outcome. Proportion participants fulfilling responder criteria every 4 weeks compared to baseline.
Time frame: From baseline to week 48
OMERACT-OARSI responder criteria based on Visual Analogue Scale hand function
Compare the three treatment arms based on OMERACT-OARSI responder criteria based on hand function measured on a digital Visual Analogue Scale ranging from 1-100 mm. The higher the score, the worse the outcome. Proportion participants fulfilling responder criteria every 4 weeks compared to baseline.
Time frame: From baseline to week 48
OMERACT-OARSI responder criteria based on patient global assessment measured with Visual Analogue Scale
Compare the three treatment arms based on OMERACT-OARSI responder criteria based on patient global assessment measured on a digital Visual Analogue Scale ranging from 1-100 mm. The higher the score, the worse the outcome. Proportion participants fulfilling responder criteria every 4 weeks compared to baseline.
Time frame: From baseline to week 48
Quality of life, measured with EuroQuol-5D-5L
Compare the three treatment arms based on Quality of Life, measured with EuroQuol-5D-5L questionnaire at week 16, 32 and 48. The EuroQol EQ-5D-5L has two measurement systems: the health state index score and the EQ Visual Analogue Scale (EQ VAS). The health state index score ranges from below zero to 1, with 1 being full health and values below zero indicating a state worse than death, depending on the specific country's value set. The EQ VAS, which measures current overall health, ranges from 0 to 100, where 100 is the best imaginable health
Time frame: From baseline to week 48
Patient experience of steroid use with the Steroid PRO
Compare the three treatment arms based on patient experience of steroid use with the Steroid PRO questionnaire every 4 weeks. Answers can be ranged from 1 to 5. Where the higher the score, the worse the outcome.
Time frame: From baseline to week 48
Changes in local inflammation of hand joints, determined with ultrasound
Compare the three treatment arms based on 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 power doppler and Greyscale score. Scores of effusion, proliferation, osteophytes and power doppler are scored between 0 to 3, where the higher the score, the worse the outcome.
Time frame: From baseline to week 4
Structural changes based on X-ray of the hands
Compare the three treatment arms based on 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.
Time frame: From baseline to week 48
Effect on joints based on swollen joint count and tender joint count
Compare the three treatment arms based on effect on affected joints based on swollen joint count (SJC) and tender joint count (TJC) at baseline, week 4 and week 48.
Time frame: From baseline to week 48
Changes of systemic inflammation
Compare the three treatment arms based on changes of systemic inflammation assessed by C-reactive protein (CRP) at week 4, 16, and 48 compared to baseline. This is scored as: normal levels being less than 10 mg/L or less than 1 mg/dL. Mild elevations (10-40 mg/L) often indicate mild infection or chronic conditions, while high levels (\>40 mg/L) suggest more significant inflammation, acute bacterial infection, or autoimmune disease.
Time frame: From baseline to week 48
Changes of systemic inflammation
Compare the three treatment arms based on changes of systemic inflammation assessed by Erythrocyte Sedimentation Rate (ESR) at week 4, 16, and 48 compared to baseline. ESR can be measured in range from 0 to high levels (above 100) mm/hour. The higher the value, the worse the outcome.
Time frame: From baseline to week 48
Medication use, health care costs by using the iMTA Productivity Cost Questionnaire
Compare the three treatment arms based on medication use, health care use and costs by using the iMTA Productivity Cost Questionnaire (iPCQ). It measures health-related productivity losses in the form of monetary values rather than standard units of measurement. It collects data on absenteeism and presenteeism in paid work and productivity loss in unpaid work, which is then used to calculate productivity costs in a currency.
Time frame: From baseline to week 48
Medication use, health care costs by using the iMTA Medical Consumption Questionnaire
Compare the three treatment arms based on medication use, health care use and costs by using the iMTA Medical Consumption Questionnaire (iMCQ). The iMCQ is an instrument for measuring medical consumption. The iMCQ includes questions related to frequently occurring contacts with health care providers.
Time frame: From baseline to week 48
Explore correlation of baseline values within treatment reponse and develop prediction model
Correlation between baseline clinical and imaging measures - pain severity (VAS, 0-100 mm), hand function (VAS score, 0-100 mm), grip strength (kg, dynamometer), and synovitis (ultrasound, 0-3 scale) - and treatment response, defined by the OMERACT-OARSI responder criteria (% of patients classified as responders). Statistical analysis: correlation/regression and development of a multivariable prediction model.
Time frame: From baseline to week 48
Explore subgroups according to structural changes on X-ray of the hand based on erosive or non-erosive, DIP osteophytes or PIP osteophytes, DIP joint space narrowing or PIP joint space narrowing at baseline.
Explore subgroups according to structural changes on X-ray of the hand based on erosive or non-erosive, DIP osteophytes or PIP osteophytes, DIP joint space narrowing or PIP joint space narrowing at baseline.
Time frame: From baseline to week 48
Assess safety of methylprednisolone 120mg or 40mg compared to placebo by assessing incidence density and cumulative incidence of AEs and SAEs
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.
Time frame: From baseline to week 48
Evaluate efficacy and safety of methylprednisolone on endpoints mentioned under 2 and 3, comparing participants based on the cumlative dose of MP
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.
Time frame: From baseline to week 48
Explore subgroup differences categorized by demographic factors
Explore subgroup differences categorized by demographic factors
Time frame: From baseline to week 48
Explore subgroup differences categorized by X-ray
Explore subgroup differences categorized by X-ray measured by joint space narrowing, osteophytes and symptom structure concordance
Time frame: From baseline to week 48
Explore subgroup differences categorized by ultrasound
Explore subgroup differences categorized by ultrasound measured by osteophytes, effusion and proliferation in DIP and PIP joints
Time frame: From baseline to week 4
Explore subgroup differences categorized by biomarkers in blood
Explore subgroup differences categorized by biomarkers in blood. Biomarkers are still unknown, and will be established during experiments.
Time frame: From baseline to week 48
Identification of circulating biomarkers associated with response to MP
Identification of circulating biomarkers associated with response to MP. Circulating biomarkers are still unknown and will be evaluated during experiments.
Time frame: From baseline to week 48
Started Oct 2025 (actual). Primary completion is estimated for Apr 2028, 30 months after the start.
Of 84 phase 3 interventional studies under Osteoarthritis, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 27. This study's planned 30 months is above that.
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Studies of the drug tested here: Methylprednisolone Acetate
Sint Maartenskliniek