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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
132
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.
11
Bari, Italy
08
Catania, Italy
10
Ferrara, Italy
12
Florence, Italy
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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01
Iesi, Italy
05
Milan, Italy
13
Milan, Italy
18
Milan, Italy
07
Modena, Italy
23
Monserrato, Italy
...and 8 more locations
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
Time frame: From Baseline to Week 1 and Week 52
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Week 0 (Baseline)