Rheumatoid Arthritis (RA)
Conditions
Keywords
power doppler (PD), ultrasonographic (US), rheumatoid arthritis (RA), disease activity scale (DAS), C-reactive protein (CRP)
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
| 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). |
| Correlation between changes of 36-joint plus 4-tendon PDUS score and disease activity DAS 28-CRP. | Baseline (Week 0) to Week 20 | — |
Countries
China
Outcome results
None listed