The purpose of this study is to evaluate the safety, tolerability and efficacy of iguratimod in adult subjects with diffuse cutaneous systemic sclerosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.
Placebo of Iguratimod
Number of Participants Who Experience Grade 3 or Higher Adverse Events That Occur at or Before Week 24
Primary outcome is met if any participants experience a grade 3 or higher event prior to Week 24. A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03.
Time frame: Week 24
Number of Grade 3 (Severe) or Higher Adverse Events That Occur Throughout the Study
Grade 3 or higher adverse events (AEs) assessed throughout the study ( 48 weeks). A grade 3 AE would constitute as "severe". Grading was following using CTCAE v 4.03.
Time frame: Week 12, 24, 36, and 48
Number of Grade 2 (Moderate) or Higher Adverse Events That Occur Throughout the Study
Grade 2 or higher assessed 12 weeks apart. Grade 2 AEs are determined as " moderate". Grading was performed following CTCAE v 4.03 guidance.
Time frame: Week 12, 24, 36, and 48
Provisional American College of Rheumatology Combined Response Index (CRISS) Systemic Sclerosis
CRISS components included the following domains: modified Rodnan skin score, forced vital capacity percent predicted, Physician Global Assessment, Patient Global Assessment, and Health Assessment Questionnaire Disability-Index. An algorithm determines the predicted probability of improvement from baseline by incorporating change in the mRSS, FVC percent predicted, Physician and Patient Global Assessments, and HAQ-DI. The outcome is a continuous variable between 0.0 and 1.0 (0 - 100%). A cut-off at 0.6 in the predicted probability of being improved has yielded the smallest misclassification error. Subjects are not considered improved if, between Visit 1 and 6, they develop new: 1) renal crisis; 2) decline in FVC% predicted by 15% (relative) from baseline and confirmed after 1 month; or 3) left ventricular failure (systolic ejection fraction \< 45%) or pulmonary artery hypertension. Higher CRISS scores indicates improvement.
Time frame: Week 12, 24, and 48
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Scleroderma Clinical Trials Consortium Damage Index
A damage Index (DI) in systemic sclerosis, including musculoskeletal and skin, vascular, gastrointestinal, respiratory and cardiovascular damage caused by SSc.
Time frame: Week 24, 48
Change in Modified Rodnan Skin Score (mRSS)
The Modified Rodnan Skin Score (mRSS) is a measure of skin thickness. Skin thickness in 17 anatomic areas was rated on a 0-3 scale and scores are summed to obtain the mRSS (range from 0 - 51), with higher mRSS scores indicating worse disease activity
Time frame: Week 12, 24, 36, and 48
Change in Skin Thickness
The skin thickness of fingers and palms would be measured by high frequency echo. detector.
Time frame: Week 24, 48