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Trial · NCT07371572

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

NCT07371572, Phase 3, Recruiting, Sint Maartenskliniek

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis. Trials, record NCT07371572. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07371572

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
The Efficacy and Safety of Intramuscular Methylprednisolone in Patients With Hand OsteoArthritis
NCT number
NCT07371572
Status
Recruiting
Phases
Phase 3
Enrollment
212 participants, estimated
Lead sponsor
Sint Maartenskliniek
Conditions
Hand Osteoarthritis
Interventions
120mg methylprednisolone acetate, 40mg methylprednisolone acetate, Placebo
First posted
2026-01-28
Last updated
2026-01-28

Source ClinicalTrials.gov

Registered outcomes26

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryEfficacy of intramuscular methylprednisolone acetate in reducing hand pain between baseline and week 4, compared to placebo measured on a 0-100 mm Visual Analogue ScaleFrom baseline to week 4
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.
SecondaryNon-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 ScaleFrom baseline to week 4
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.
SecondaryChange in hand pain at week 4, and thereafter every 4 weeksFrom week 8 to week 48
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.
SecondaryPercentage of participants with a reduction in hand pain larger than the MCIDFrom baseline to week 4Compare 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
SecondaryHand function, change in functional indexFrom baseline to week 48
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.
SecondaryOMERACT-OARSI responder criteria based on pain measured with Visual Analogue ScaleFrom baseline to week 48
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.
SecondaryOMERACT-OARSI responder criteria based on Visual Analogue Scale hand functionFrom baseline to week 48
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.
SecondaryOMERACT-OARSI responder criteria based on patient global assessment measured with Visual Analogue ScaleFrom baseline to week 48
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.
SecondaryQuality of life, measured with EuroQuol-5D-5LFrom baseline to week 48
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
SecondaryPatient experience of steroid use with the Steroid PROFrom baseline to week 48
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.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07371572

GET https://conductscience.org/api/trials/v1/NCT07371572/registered?page=2