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Validity of early MRI structural damage end points and potential impact on clinical trial design in rheumatoid
Joshua F Baker1, Philip G Conaghan2, Paul Emery2
1Philadelphia Veterans' Affairs Medical Center, Philadelphia, Pennsylvania, USA University of Pennsylvania, School of Medicine, Philadelphia, Pennsylvania, USA Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Objective:
To evaluate the construct validity of the rheumatoid arthritis MRI score (RAMRIS) erosion evaluation as structural damage end point and to assess the potential impact of incorporation in clinical trials.
Methods:
In a randomised trial of early methotrexate-naïve RA (GO-BEFORE), RAMRIS scores were determined from MRIs and van der Heijde-Sharp (vdHS) scores from radiographs, at baseline, week 12, week 24 and week 52. Progression in damage scores was defined as change >0.5. Associations of X-ray and MRI outcomes with clinical features were evaluated for convergent validity. Iterative Wilcoxon rank sum tests and tests of proportion estimated the sample size required to detect differences between combination therapy (methotrexate+golimumab) and methotrexate-monotherapy arms in (A) change in damage score and (B) proportion of patients progressing.
Results:
Patients with early MRI progression had higher DAS28, C reactive protein (CRP) and vdHS at baseline, and higher 2-year HAQ. Associations were similar to those with 1-year vdHS progression. Differences in change in structural damage between treatment arms achieved significance with fewer subjects when 12-week or 24-week MRI erosion score was the outcome (150 patients; 100 among an enriched sample with baseline-synovitis >5) compared with the 52-week vdHS (275 patients). Differences in the proportion progressing could be detected in 234 total subjects with 12-week MRI in an enriched sample whereas 1-year X-ray required between 468 and 1160 subjects.
Conclusions:
Early MRI erosion progression is a valid measure of structural damage that could substantially decrease sample size and study duration if used as structural damage end point in RA clinical trials.
Insights
Rheumatoid arthritis MRI erosion scores offer a valid measure of structural damage. Using MRI in clinical trials can significantly reduce patient numbers and study length compared to X-rays.
Area of Science:
- Rheumatology
- Medical Imaging
- Clinical Trials
Background:
- Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by joint inflammation and progressive structural damage.
- Evaluating structural damage in RA clinical trials is crucial for assessing treatment efficacy.
- Current methods, like radiographic scoring (van der Heijde-Sharp), often require long follow-up periods.
Purpose of the Study:
- To assess the construct validity of the Rheumatoid Arthritis MRI Score (RAMRIS) erosion evaluation as a structural damage endpoint.
- To determine the impact of incorporating RAMRIS erosion scores into clinical trial design, specifically regarding sample size and study duration.
Main Methods:
- A randomized trial (GO-BEFORE) of early methotrexate-naïve RA patients was analyzed.
- RAMRIS scores from MRI and van der Heijde-Sharp (vdHS) scores from radiographs were collected at multiple time points (baseline, week 12, 24, 52).
- Sample size calculations were performed to compare the ability of MRI and radiographic scores to detect treatment differences between combination therapy and methotrexate monotherapy.
Main Results:
- Early MRI erosion progression correlated with higher clinical disease activity (DAS28, CRP) and functional disability (HAQ).
- Using 12-week or 24-week RAMRIS erosion scores required significantly fewer patients (150) to detect treatment differences compared to 52-week vdHS scores (275).
- Detecting differences in the proportion of patients progressing was more efficient with 12-week MRI (234 subjects) than 1-year X-ray (468-1160 subjects).
Conclusions:
- Early MRI erosion progression is a valid and sensitive measure of structural damage in rheumatoid arthritis.
- Incorporating RAMRIS erosion scores as a primary endpoint in RA clinical trials can substantially reduce required sample size and shorten study duration.
- This approach has the potential to accelerate the evaluation of new RA therapies.
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