| 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 | 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. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | From Baseline to Week 12 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00069.1(58.78 to 78.27)
|
|
| |
| 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 | 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. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | From Baseline to Week 8 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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 | 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. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | From Baseline to Week 6 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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 | 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. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | From Baseline to Week 4 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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 | 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. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | From Baseline to Week 2 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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 | 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. | Posted | | Number | 95% Confidence Interval | percentage of subjects | | From Baseline to Week 1 and Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
| |
| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | From Baseline to Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 0 (Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 0 (Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 24 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 1 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 0 (Baseline) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 52 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 12 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 8 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 4 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 2 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 1 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 0 (Baseline) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 24 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | | Posted | | Median | Full Range | units on a scale | | Week 2 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 1 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 0 (Baseline) | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 52 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 36 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 24 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 12 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 8 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 6 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 4 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 2 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 1 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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). | Posted | | Median | Full Range | units on a scale | | Week 0 (Baseline) | | | | ID | Title | Description |
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| OG000 | 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. |
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