The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).
Magnetic resonance imaging (MRI) is a powerful imaging modality that is now widely used in both scientific research and clinical settings to visualise joints of patients with RA. MRI is able to image structural damage and soft tissue changes, ie, synovitis, bone oedema, damage to cartilage and bone, as well as tendon pathology. MRI is more responsive to change in joint damage and can be used to monitor disease progression. In this studly,MRI of the dominant wrist was performed at baseline ,24 weeks and at 52 weeks, using a 1.5T or 3.0T MRI with a dedicated high-resolution wrist phased array coil.The same scanner and wrist coil were used for three examinations. The hand was placed in the wrist coil at the patient's side with the coil anchored to the base tray to reduce motion artefacts. The MRI sequences in this study included the OMERACT recommended MRI core set of sequences.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week; Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week.
Third Affiliated Hospital Of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGChange from baseline in RA magnetic resonance imaging scoring system (RAMRIS)
Time frame: week 52
Change from baseline in modified Total Sharp Score (mTSS)
Time frame: week 52
Percentage of patients with ACR 20 response
Time frame: week 52
Change in Disease Activity as measured by the DAS28
Time frame: week 52
Change from baseline in RAMRIS
Time frame: week 24
Change from baseline in mTSS
Time frame: week 24
Percentage of patients with ACR 20 response
Time frame: week 10, week 24, week 40
Change from baseline in Disease Activity Score 28 (DAS28)
Time frame: : week 10, week 24, week 40
Percentage of patients with ACR 50 response
Time frame: week 10, week 24, week 40, week 52
Percentage of patients with ACR 70 response
Time frame: week 10, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3
Time frame: week 10, week 24, week 40, week 52
Change from baseline in Simplified Disease Activity Index (SDAI)
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Time frame: week 10, week 24, week 40, week 52
Change from baseline in Health Assessment Questionnaire (HAQ)
Time frame: week 10, week 24, week 40, week 52