Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis (RA) Patients With Inadequate Response to Methotrexate

Withdrawn

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Moderate to severe RA despite treatment with methotrexate (MTX).
Eligible to use adalimumab according to the local label without any contraindication.
Naïve to adalimumab, and participants with prior exposure to any other biologic disease-modifying antirheumatic drugs (DMARDs) should have experienced at least five half-lives of the biologics after treatment discontinuation.
Participants for whom investigators decided to prescribe adalimumab as per local label and are initiating adalimumab at baseline.

Exclusion Criteria

Other inflammatory condition which may affect the signs on joints ultrasound (eg, gouty arthritis, or other chronic rheumatic disease besides RA).
Currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days of the baseline visit.
Participants with contraindication or are not appropriate to use adalimumab according to local label or investigators' judgment.

Primary Outcome Measures

Name	Time	Method
Change in power Doppler (PD) semi-quantitative scores from baseline	Week 0 (baseline) and Week 12	Change in PD semi-quantitative scores from baseline at week 12, using 36-joint scoring system
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.	Week 0 (baseline) and Week 12	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.
Change from baseline in grey-scale (GS) scores	Week 0 (baseline) and Week 12	Change in GS scores from baseline at Week 12, using 36-joint scoring system

Secondary Outcome Measures

Name	Time	Method
Correlation between changes of 36-joint plus 4-tendon PDUS score and disease activity DAS 28-CRP.	Baseline (Week 0) to Week 20
Percentage of participants achieving low disease activity	Baseline (Week 0) to Week 12 and Week 20	The percentage of participants achieving low disease activity (LDA, DAS 28-CRP greater than or equal to 2.6 but less than 3.2).
Change from baseline in counts of joints with US detected bone erosion	Baseline (Week 0) to Week 12	The change in counts of joints with US detected bone erosion.
Percentage of patients achieving clinical remission	Baseline (Week 0) to Week 12 and Week 20	The percentage of participants achieving clinical remission (DAS 28-CRP less than 2.6).
Change in DAS 28-CRP from baseline	Baseline (Week 0) to Week 12 and Week 20	The Disease Activity Score C-Reactive Protein (DAS 28-CRP); 4 variables, using 28-joint counts and CRP.

Locations (4): Peking University Peoples Hospit /ID# 148961
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Beijing, Beijing, China
Xijing Hospital /ID# 148960
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Xian, Shaanxi, China
Renji Hosp, Shanghai Jiaotong /ID# 148959
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Shanghai, China
Hosp Ppl Liberation Army 301 /ID# 148962
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Beijing, China

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