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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rheumatoid Arthritis (RA)

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with RA receiving adalimumab<br>This group contains participants in China with RA receiving adalimumab | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in grey-scale (GS) scores | Change in GS scores from baseline at Week 12, using 36-joint scoring system | 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 | 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. | Week 0 (baseline) and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in counts of joints with US detected bone erosion | The change in counts of joints with US detected bone erosion. | 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). | 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. |  | Baseline (Week 0) to Week 20 | 
| Percentage of patients achieving clinical remission | The percentage of participants achieving clinical remission (DAS 28-CRP less than 2.6). | 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. | Baseline (Week 0) to Week 12 and Week 20 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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power doppler (PD), ultrasonographic (US), rheumatoid arthritis (RA), disease activity scale (DAS), C-reactive protein (CRP)