Protocol for the MERINO study: A randomized placebo-controlled trial assessing the efficacy, safety, and cost-effectiveness of methotrexate in people with erosive hand osteoarthritis
Bibliographic record
Abstract
Objective: Previous studies on the efficacy of methotrexate in people with hand osteoarthritis (OA) have shown conflicting results. The MERINO trial aims to investigate the efficacy and safety of methotrexate in people with painful inflammatory erosive hand OA. Design: In total 163 participants with erosive hand OA, synovitis by ultrasound, and finger joint pain of 40-80 mm on a visual analogue scale (VAS) will be recruited from a rheumatology outpatient clinic. Participants are randomized 1:1 to receive either encapsulated oral methotrexate 20 mg/week or placebo for 12 months in a double-blind manner. The primary endpoint is VAS finger joint pain at 6 months. Key secondary outcomes are hand function by the Australian/Canadian hand index (AUSCAN) at 6 months and radiographic progression by the Verbruggen-Veys anatomical phase scoring system at 12 months. Other secondary endpoints include hand stiffness, disease activity, health-related quality of life, grip strength, clinical joint counts, synovitis by ultrasound and MRI, bone marrow lesions by MRI, cost-effectiveness, and symptoms in knees and hips. Adverse events will be recorded. The primary analysis will be performed on full analysis set. Conclusions: The findings of this trial will be clinically relevant for patients with erosive hand OA and may influence future treatment recommendations. Clinical trial registration: EU CT number: 2023-510523-30-00, NCT04579848.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.025 | 0.025 |
| Meta-epidemiology (narrow) | 0.007 | 0.003 |
| Meta-epidemiology (broad) | 0.010 | 0.004 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.004 | 0.004 |
| Scholarly communication | 0.004 | 0.005 |
| Open science | 0.003 | 0.002 |
| Research integrity | 0.009 | 0.011 |
| Insufficient payload (model declined to judge) | 0.116 | 0.029 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".