Rheumatoid Arthritis
Conditions
Keywords
Certolizumab pegol - Cimzia, Rheumatoid Arthritis, Power Doppler Ultrasonography, Italy, Moderate-severe Rheumatoid Arthritis
Brief summary
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.
Interventions
BIOLOGICALCertolizumab pegol
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.
Sponsors
UCB Italy s.p.a.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52 | From Baseline to Week 12 and 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 |
| The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52 | From Baseline to Week 8 and 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 |
| The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52 | From Baseline to Week 6 and 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 |
| The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52 | From Baseline to Week 4 and 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 |
| The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52 | From Baseline to Week 2 and 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 |
| The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52 | From Baseline to Week 1 and 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Synovial Fluid and Proliferation at Week 4 | From Baseline to 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. |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 2 | From Baseline to 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. |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 1 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 52 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 36 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 24 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 12 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 8 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 6 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 4 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 2 | From Baseline to 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. |
| Change From Baseline in the Doppler Signal and Blood Flow at Week 1 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 52 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 36 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 24 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 12 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 52 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 8 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 6 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 4 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 2 | From Baseline to 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. |
| Change From Baseline in the Cartilage Damage at Week 1 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 36 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 24 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 12 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 8 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 6 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 4 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 2 | From Baseline to 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. |
| Change From Baseline in the Bone Erosion at Week 1 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 | From Baseline to 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. |
| Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 | From Baseline to 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. |
| Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 | From Baseline to 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. |
| Synovial Fluid and Proliferation at Week 52 | 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. |
| Synovial Fluid and Proliferation at Week 36 | 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. |
| Synovial Fluid and Proliferation at Week 24 | 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. |
| Synovial Fluid and Proliferation at Week 12 | 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. |
| Synovial Fluid and Proliferation at Week 8 | 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. |
| Synovial Fluid and Proliferation at Week 6 | 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. |
| Synovial Fluid and Proliferation at Week 4 | 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. |
| Synovial Fluid and Proliferation at Week 2 | 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. |
| Synovial Fluid and Proliferation at Week 1 | 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. |
| Synovial Fluid and Proliferation at Week 0 | Week 0 (Baseline) | 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. |
| Doppler Signal and Blood Flow at Week 52 | 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. |
| Doppler Signal and Blood Flow at Week 36 | 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. |
| Doppler Signal and Blood Flow at Week 24 | 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. |
| Doppler Signal and Blood Flow at Week 12 | 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. |
| Doppler Signal and Blood Flow at Week 8 | 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. |
| Doppler Signal and Blood Flow at Week 6 | 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. |
| Doppler Signal and Blood Flow at Week 4 | 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. |
| Doppler Signal and Blood Flow at Week 2 | 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. |
| Doppler Signal and Blood Flow at Week 1 | 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. |
| Doppler Signal and Blood Flow at Week 0 | Week 0 (Baseline) | 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. |
| Cartilage Damage at Week 52 | 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. |
| Cartilage Damage at Week 36 | 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. |
| Cartilage Damage at Week 24 | 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. |
| Cartilage Damage at Week 12 | 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. |
| Cartilage Damage at Week 8 | 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. |
| Cartilage Damage at Week 6 | 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. |
| Cartilage Damage at Week 4 | 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. |
| Cartilage Damage at Week 2 | 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. |
| Cartilage Damage at Week 1 | 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. |
| Cartilage Damage at Week 0 | Week 0 (Baseline) | 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. |
| Bone Erosion at Week 52 | 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. |
| Bone Erosion at Week 36 | 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. |
| Bone Erosion at Week 24 | 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. |
| Bone Erosion at Week 12 | 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. |
| Bone Erosion at Week 8 | 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. |
| Bone Erosion at Week 6 | 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. |
| Bone Erosion at Week 4 | 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. |
| Bone Erosion at Week 2 | 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. |
| Bone Erosion at Week 1 | 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. |
| Bone Erosion at Week 0 | Week 0 (Baseline) | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 | 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. |
| Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0 | Week 0 (Baseline) | 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. |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 52 | From Baseline to 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0 | Week 0 (Baseline) | 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. |
| Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 | 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. |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 36 | From Baseline to 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. |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 24 | From Baseline to 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. |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 12 | From Baseline to 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. |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 8 | From Baseline to 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. |
| Change From Baseline in the Synovial Fluid and Proliferation at Week 6 | From Baseline to 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. |
Countries
Italy
Participant flow
Recruitment details
This study started to enroll patients in December 2011 and concluded in May 2015.
Pre-assignment details
Participant Flow refers to all subjects randomized who have received at least one dose of study medication.
Participants by arm
| Arm | Count |
|---|---|
| Certolizumab Pegol Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50. | 132 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | AE, non-serious non-fatal | 8 |
| Overall Study | Lack of Efficacy | 14 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Other Reason | 4 |
| Overall Study | SAE, non-fatal | 6 |
| Overall Study | SAE, non-fatal+AE, non-serious non-fatal | 1 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Certolizumab Pegol |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 38 Participants |
| Age, Categorical Between 18 and 65 years | 94 Participants |
| Age, Continuous | 54.8 years STANDARD_DEVIATION 13.2 |
| BMI | 25.66 kg/m^2 STANDARD_DEVIATION 4.52 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Height | 164.16 centimeter STANDARD_DEVIATION 8.48 |
| Sex: Female, Male Female | 108 Participants |
| Sex: Female, Male Male | 24 Participants |
| Weight | 69.33 kilogram STANDARD_DEVIATION 14.1 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 31 / 132 |
| serious Total, serious adverse events | 16 / 132 |
Outcome results
Primary
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
Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | The Percentage of Subjects With Clinical Response at Week 12 Who Also Had Clinical Response at Week 52 | 69.1 percentage of subjects |
Primary
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
Time frame: From Baseline to Week 1 and Week 52
Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | The Percentage of Subjects With Clinical Response at Week 1 Who Also Had Clinical Response at Week 52 | 55.8 percentage of subjects |
Primary
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
Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | The Percentage of Subjects With Clinical Response at Week 2 Who Also Had Clinical Response at Week 52 | 64.9 percentage of subjects |
Primary
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
Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | The Percentage of Subjects With Clinical Response at Week 4 Who Also Had Clinical Response at Week 52 | 66.7 percentage of subjects |
Primary
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
Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | The Percentage of Subjects With Clinical Response at Week 6 Who Also Had Clinical Response at Week 52 | 65.2 percentage of subjects |
Primary
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
Population: The Full Analysis Set (FAS) will consist of all subjects in the Safety Set (SS) who have a valid baseline and valid post-baseline efficacy measurement for the primary variable (DAS28-ESR). One Subject from the SS has been excluded from the FAS Set.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Certolizumab Pegol | The Percentage of Subjects With Clinical Response at Week 8 Who Also Had Clinical Response at Week 52 | 69.8 percentage of subjects |
Secondary
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)
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 0 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 1 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 12 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 2 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 24 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 36 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 4 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 52 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 6 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Bone Erosion at Week 8 | 2.0 units on a scale |
Secondary
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)
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 0 | 6.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 1 | 5.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 12 | 5.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 2 | 4.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 24 | 4.5 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 36 | 5.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 4 | 4.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 52 | 4.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 6 | 4.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Cartilage Damage at Week 8 | 4.5 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 | -3.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 | -2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 | -3.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 | -3.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 | -2.5 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 | -3.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 | -2.5 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 | -3.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 1 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 12 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 2 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 24 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 36 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 4 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 52 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 6 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Bone Erosion at Week 8 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 1 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 12 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 2 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 24 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 36 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 4 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 52 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 6 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Cartilage Damage at Week 8 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 1 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 12 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 2 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 24 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 36 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 4 | -0.5 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 52 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 6 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Doppler Signal and Blood Flow at Week 8 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 | -2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 | -1.5 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 | -2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 | -2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 | -2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 | -2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 1 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 12 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 2 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 24 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 36 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 4 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 52 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 6 | -1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Change From Baseline in the Synovial Fluid and Proliferation at Week 8 | -1.0 units on a scale |
Secondary
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)
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 0 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 1 | 1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 12 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 2 | 1.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 24 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 36 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 4 | 2.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 52 | 0.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 6 | 0.5 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Doppler Signal and Blood Flow at Week 8 | 0.0 units on a scale |
Secondary
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)
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 0 | 12.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 1 | 10.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 12 | 9.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 2 | 10.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 24 | 10.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 36 | 8.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 4 | 8.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 52 | 7.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 6 | 8.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Progression in the Doppler Signal, Cartilage Damage and Bone Erosion Score at Week 8 | 9.0 units on a scale |
Secondary
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)
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 0 | 10.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 1 | 8.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 12 | 7.0 units on a scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 2 | 8.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 24 | 6.5 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 36 | 6.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 4 | 8.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 52 | 5.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 6 | 7.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Sum of the Synovial Fluid and Synovial Proliferation, and Doppler Signal/Blood Flow at Week 8 | 6.0 units on a scale |
Secondary
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)
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 0 | 8.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 1 | 7.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 12 | 5.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 2 | 7.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 24 | 5.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 36 | 5.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 4 | 6.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 52 | 5.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 6 | 6.0 units on a scale |
Secondary
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
Population: Full Analysis Set (FAS) with Last Observation Carried Forward (LOCF). The FAS will consist of all subjects in the Safety Set who have a valid Baseline and valid post-Baseline efficacy measurement for the primary variable (DAS28-ESR).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Certolizumab Pegol | Synovial Fluid and Proliferation at Week 8 | 5.0 units on a scale |