Open Label Study to Assess the Predictability of Early Response to Certolizumab Pegol in Patients With Rheumatoid Arthritis

Study Overview
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Brief Summary
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The study aims to evaluate the predictability of early response to Certolizumab pegol in combination with Methotrexate at one year in patients with moderate to severe rheumatoid arthritis.

Official Title
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Multicenter, Open Label Study to Evaluate the Predictability of Early Response to Certolizumab Pegol (in Combination With Methotrexate) as Confirmed at Week 52 in Subjects With Moderate-severe Rheumatoid Arthritis (RA)

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Certolizumab pegol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of adult-onset Rheumatoid Arthritis (RA) for a duration of at least 6 months but not longer than 5 years positive Rheumatoid Factor (RF) and/or positive anti Cyclic Citrullinated Peptide (anti-CCP) active RA disease subjects must have failed at least one traditional Disease Modifying Anti-Rheumatic Drug (DMARD). subject is naïve to RA related biologics Exclusion Criteria: a diagnosis of any other inflammatory arthritis history of infected joint prosthesis, or other significant infection known Tuberculosis (TB) disease or high risk of acquiring TB infection

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Certolizumab pegol<br> | Biological: Certolizumab pegol<br>* Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.<br>* Other names: CZP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52 | Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system | From Baseline to Week 12 and Week 52 | 
| The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52 | Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system | From Baseline to Week 8 and Week 52 | 
| The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52 | Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system | From Baseline to Week 6 and Week 52 | 
| The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52 | Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system | From Baseline to Week 4 and Week 52 | 
| The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52 | Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system | From Baseline to Week 2 and Week 52 | 
| The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52 | Clinical response is defined as a reduction from Baseline (Week 0) of more than 1.2 scores in the Disease Activity Score28 [Erythrocyte Sedimentation Rate] (DAS28-ESR) scoring system | From Baseline to Week 1 and Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 52 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints, with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 52 | 
| Change From Baseline in the Synovial Fluid and Proliferation at Week 36 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 36 | 
| Change From Baseline in the Synovial Fluid and Proliferation at Week 24 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 24 | 
| Change From Baseline in the Synovial Fluid and Proliferation at Week 12 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 12 | 
| Change From Baseline in the Synovial Fluid and Proliferation at Week 8 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 8 | 
| Change From Baseline in the Synovial Fluid and Proliferation at Week 6 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 6 | 
| Change From Baseline in the Synovial Fluid and Proliferation at Week 4 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 4 | 
| Change From Baseline in the Synovial Fluid and Proliferation at Week 2 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 2 | 
| Change From Baseline in the Synovial Fluid and Proliferation at Week 1 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 1 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 52 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 52 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 36 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 36 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 24 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 24 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 12 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 12 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 8 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 8 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 6 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 6 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 4 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 4 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 2 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 2 | 
| Change From Baseline in the Doppler Signal and Blood Flow at Week 1 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | From Baseline to Week 1 | 
| Change From Baseline in the Cartilage Damage at Week 52 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 52 | 
| Change From Baseline in the Cartilage Damage at Week 36 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 36 | 
| Change From Baseline in the Cartilage Damage at Week 24 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 24 | 
| Change From Baseline in the Cartilage Damage at Week 12 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 12 | 
| Change From Baseline in the Cartilage Damage at Week 8 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 8 | 
| Change From Baseline in the Cartilage Damage at Week 6 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 6 | 
| Change From Baseline in the Cartilage Damage at Week 4 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 4 | 
| Change From Baseline in the Cartilage Damage at Week 2 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 2 | 
| Change From Baseline in the Cartilage Damage at Week 1 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 1 | 
| Change From Baseline in the Bone Erosion at Week 52 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 52 | 
| Change From Baseline in the Bone Erosion at Week 36 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 36 | 
| Change From Baseline in the Bone Erosion at Week 24 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 24 | 
| Change From Baseline in the Bone Erosion at Week 12 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 12 | 
| Change From Baseline in the Bone Erosion at Week 8 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 8 | 
| Change From Baseline in the Bone Erosion at Week 6 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 6 | 
| Change From Baseline in the Bone Erosion at Week 4 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 4 | 
| Change From Baseline in the Bone Erosion at Week 2 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 2 | 
| Change From Baseline in the Bone Erosion at Week 1 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | From Baseline to Week 1 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 52 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 36 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 24 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 12 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 8 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 6 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 4 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 2 | 
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | From Baseline to Week 1 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 52 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 36 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 24 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 12 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 8 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 6 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 4 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 2 | 
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | From Baseline to Week 1 | 
| Synovial Fluid and Proliferation at Week 52 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 52 | 
| Synovial Fluid and Proliferation at Week 36 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 36 | 
| Synovial Fluid and Proliferation at Week 24 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 24 | 
| Synovial Fluid and Proliferation at Week 12 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 12 | 
| Synovial Fluid and Proliferation at Week 8 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 8 | 
| Synovial Fluid and Proliferation at Week 6 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 6 | 
| Synovial Fluid and Proliferation at Week 4 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 4 | 
| Synovial Fluid and Proliferation at Week 2 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 2 | 
| Synovial Fluid and Proliferation at Week 1 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 1 | 
| Synovial Fluid and Proliferation at Week 0 | The synovial fluid and proliferation is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 0 (Baseline) | 
| Doppler Signal and Blood Flow at Week 52 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 52 | 
| Doppler Signal and Blood Flow at Week 36 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 36 | 
| Doppler Signal and Blood Flow at Week 24 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 24 | 
| Doppler Signal and Blood Flow at Week 12 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 12 | 
| Doppler Signal and Blood Flow at Week 8 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 8 | 
| Doppler Signal and Blood Flow at Week 6 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 6 | 
| Doppler Signal and Blood Flow at Week 4 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 4 | 
| Doppler Signal and Blood Flow at Week 2 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 2 | 
| Doppler Signal and Blood Flow at Week 1 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 1 | 
| Doppler Signal and Blood Flow at Week 0 | The Doppler signal and blood flow is a semiquantitative score (0-3 on each of 6 joints with a minimum score of 0 and a maximum score of 18). A greater score indicates greater disease activity. | Week 0 (Baseline) | 
| Cartilage Damage at Week 52 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 52 | 
| Cartilage Damage at Week 36 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 36 | 
| Cartilage Damage at Week 24 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 24 | 
| Cartilage Damage at Week 12 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 12 | 
| Cartilage Damage at Week 8 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 8 | 
| Cartilage Damage at Week 6 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 6 | 
| Cartilage Damage at Week 4 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 4 | 
| Cartilage Damage at Week 2 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 2 | 
| Cartilage Damage at Week 1 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 1 | 
| Cartilage Damage at Week 0 | The Cartilage damage is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 0 (Baseline) | 
| Bone Erosion at Week 52 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 52 | 
| Bone Erosion at Week 36 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 36 | 
| Bone Erosion at Week 24 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 24 | 
| Bone Erosion at Week 12 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 12 | 
| Bone Erosion at Week 8 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 8 | 
| Bone Erosion at Week 6 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 6 | 
| Bone Erosion at Week 4 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 4 | 
| Bone Erosion at Week 2 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 2 | 
| Bone Erosion at Week 1 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 1 | 
| Bone Erosion at Week 0 | The bone erosion is a semiquantitative score (0-4 on each of 6 joints with a minimum score of 0 and a maximum score of 24). A greater score indicates greater disease severity. | Week 0 (Baseline) | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 52 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 36 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 24 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 12 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 8 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 6 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 4 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 2 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 1 | 
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0 | The sum of the synovial fluid volume, synovial proliferation, Doppler Signal and Blood Flow is a score (0-6 on each of 6 joints with a minimum score of 0 and a maximum score of 36). A greater score indicates greater disease activity. | Week 0 (Baseline) | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 52 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 36 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 24 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 12 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 8 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 6 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 4 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 2 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 1 | 
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0 | The sum of the progression in the Doppler signal, cartilage damage and bone erosion score is a score (0-11 on each of 6 joints with a minimum score of 0 and a maximum score of 66). A greater score indicates greater disease severity. | Week 0 (Baseline) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Certolizumab pegol - Cimzia, Rheumatoid Arthritis, Power Doppler Ultrasonography, Italy, Moderate-severe Rheumatoid Arthritis