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Strategic considerations
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with RA receiving adalimumab | This group contains participants in China with RA receiving adalimumab |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants receiving adalimumab with Rheumatoid Arthritis (RA) in China
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Peoples Hospit /ID# 148961 | Beijing | Beijing Municipality | 100044 | China | ||
| Xijing Hospital /ID# 148960 |
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| Label | URL |
|---|---|
| Related Info | View source |
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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 |
| Xi'an |
| Shaanxi |
| 710032 |
| China |
| Hosp Ppl Liberation Army 301 /ID# 148962 | Beijing | 100034 | China |
| Renji Hosp, Shanghai Jiaotong /ID# 148959 | Shanghai | 200127 | China |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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