Prospective, post-marketing, multi-center, open-label study to explore if the initiation of adalimumab could influence grey-scale (GS) and power Doppler (PD) ultrasonographic (US) score using 36-joint plus 4-tendon scoring system, and validate the applicability of different simplified US joint scoring systems.
Study Type
OBSERVATIONAL
Peking University Peoples Hospit /ID# 148961
Beijing, Beijing Municipality, China
Xijing Hospital /ID# 148960
Xi'an, Shaanxi, China
Hosp Ppl Liberation Army 301 /ID# 148962
Beijing, China
Renji Hosp, Shanghai Jiaotong /ID# 148959
Shanghai, China
Change from baseline in grey-scale (GS) scores
Change in GS scores from baseline at Week 12, using 36-joint scoring system
Time frame: Week 0 (baseline) and Week 12
Change in power Doppler (PD) semi-quantitative scores from baseline
Change in PD semi-quantitative scores from baseline at week 12, using 36-joint scoring system
Time frame: Week 0 (baseline) and Week 12
Correlation between the 36-joint plus 4-tendon assessment versus simplified joint power Doppler (PD) ultrasonographic (US) assessments, which include 12-joint/7-joint/6-joint plus 4-tendon systems.
Correlation coefficients will be presented to assess the correlation between the 36-joint plus 4-tendon PDUS assessment versus the simplified 12-joint/7-joint/6-joint plus 4-tendon assessments.
Time frame: Week 0 (baseline) and Week 12
Change from baseline in counts of joints with US detected bone erosion
The change in counts of joints with US detected bone erosion.
Time frame: Baseline (Week 0) to Week 12
Percentage of participants achieving low disease activity
The percentage of participants achieving low disease activity (LDA, DAS 28-CRP greater than or equal to 2.6 but less than 3.2).
Time frame: Baseline (Week 0) to Week 12 and Week 20
Correlation between changes of 36-joint plus 4-tendon PDUS score and disease activity DAS 28-CRP.
Time frame: Baseline (Week 0) to Week 20
Percentage of patients achieving clinical remission
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The percentage of participants achieving clinical remission (DAS 28-CRP less than 2.6).
Time frame: Baseline (Week 0) to Week 12 and Week 20
Change in DAS 28-CRP from baseline
The Disease Activity Score C-Reactive Protein (DAS 28-CRP); 4 variables, using 28-joint counts and CRP.
Time frame: Baseline (Week 0) to Week 12 and Week 20