Patterns and predictors of change in outcome measures in clinical trials in scleroderma: an individual patient meta-analysis of 629 subjects with diffuse cutaneous systemic sclerosis.

ABSTRACT:

Objective

To examine the range and responsiveness to change of clinical outcome measures and study predictors of clinical response in patients with diffuse cutaneous systemic sclerosis (dcSSc) in the context of clinical trials.

Methods

Data were combined from 629 patients with dcSSc who participated in 7 multicenter clinical therapeutic trials. Trials used common outcome measures: modified Rodnan skin thickness score (MRSS), Health Assessment Questionnaire disability index (HAQ DI), patient's global assessment of disease activity, pulmonary function tests (forced vital capacity, diffusing capacity for carbon monoxide), hand span, and oral aperture.

Results

The combined database included 629 patients (82% women, mean ± SD age 46.5 ± 11.8 years, mean ± SD disease durati

SUBMITTER: Merkel PA 

PROVIDER: S-EPMC3357459 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature