Validity of early MRI structural damage end points and potential impact on clinical trial design in rheumatoid arthritis.

ABSTRACT:

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 a

SUBMITTER: Baker JF 

PROVIDER: S-EPMC4826311 | biostudies-literature | 2016 Jun

REPOSITORIES: biostudies-literature