Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Monoclonal antibody, Interleukin-6, Olokizumab, CDP6038
Brief summary
The purpose of this study is to evaluate the long-term safety and tolerability of CDP6038 (olokizumab) treatment in adult subjects with active rheumatoid arthritis (RA) who completed study RA0083 \[NCT01463059\].
Detailed description
Male and female subjects were randomized in a multi-center, open-label, follow-up study to assess the long-term safety and efficacy of a subcutaneous dose of 120 mg CDP6038 (olokizumab), every 2 weeks (q2w), for the treatment of active RA.
Interventions
BIOLOGICALCDP6038 (olokizumab)
Biological/Vaccine: CDP6038 (olokizumab) 100 mg/mL solution for subcutaneous (sc) injection
Sponsors
R-Pharm
UCB BIOSCIENCES, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
RA0089 is a single arm study, however, analysis will also be performed according to the original treatment arms of the parent study NCT01463059 (RA0083).
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Completed the RA0083 \[NCT01463059\] study (Week 12 Visit) * Must have maintained their stable dose (and route) of methotrexate (MTX) between 6 to 16 mg/week in Japan or 7.5 to 20 mg/week in Korea and Taiwan in RA0083 \[NCT01463059\], and plan to maintain this same dose and route of administration for at least 12 weeks * Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception
Exclusion criteria
* Have an ongoing SAE from the RA0083 \[NCT01463059\] study * Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks * Have evidence of active or latent tuberculosis (TB) * Subject is receiving any biologic response modifier or synthetic disease-modifying antirheumatic drug (DMARD) other than MTX * Subject has planned surgery during the first 12 weeks of the study * Subjects who tested positive for hepatitis B core antibody (HBcAb) and/or hepatitis B surface antibody (HBsAb) at Screening in RA0083 \[NCT01463059\] and who subsequently test positive for hepatitis B virus deoxyribonucleic acid (HBV DNA) at Week 12 of RA0083 \[NCT01463059\]
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days) | Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089) | DAS28(CRP) was calculated using tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), and CRP as per formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: •TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. 28 joints included shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores greater than (\>) 5.1 correspond with active disease, scores less than (\<) 3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. |
| Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. |
| Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. |
| Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no results data are available for analysis at the Week 96 time point and this Outcome Measure has zero total participants analyzed. |
| The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089) | ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, Physician's Global Assessment of Disease Activity (PhGADA)-VAS, Patient's Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089) | ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089) | ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089) | ACR20: at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed. |
| The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089) | ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089) | ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089) | ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089) | ACR50:atleast 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed. |
| The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089) | ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089) | ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089) | ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. |
| The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089) | ACR70:atleast 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed. |
| Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089 | Week 12 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported. |
| Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089 | Week 24 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported. |
| Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089 | Week 48 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported. |
| Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089 | Week 96 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed. |
| Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089 | Week 12 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) less than or equal to (≤) 3.2 were reported. |
| Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089 | Week 24 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported. |
| Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089 | Week 48 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported. |
| Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089 | Week 96 (Study RA0089) | DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed. |
| Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089) | CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity. |
| Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089) | CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed. |
| Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089) | SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL\]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity. |
| Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089 | Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089) | SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL\]), as per formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed. |
| Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120 | Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120 | The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed. |
| Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120 | Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120 | The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed. |
Countries
Japan, South Korea, Taiwan
Participant flow
Recruitment details
The present study was an open-label extension to study RA0083 (NCT01463059). Subjects completing the 12-week treatment period of study RA0083 had the opportunity to participate in this study. First subject enrolled: 26 January 2012. Last subject completed: 27 November 2013.
Pre-assignment details
105 subjects completed the parent Study RA0083 (NCT01463059); 103 subjects were enrolled in Study RA0089.
Participants by arm
| Arm | Count |
|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w CDP6038 (olokizumab) 120 mg administered q2w sc in Study RA0083, and maintained at same dose (i.e. 120 mg q2w sc) at start of Study RA0089 (Week 12 of RA0083). | 10 |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w CDP6038 (olokizumab) 120 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083). | 15 |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w CDP6038 (olokizumab) 240 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083). | 11 |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w CDP6038 (olokizumab) 60 mg administered q2w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083). | 15 |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w CDP6038 (olokizumab) 60 mg administered q4w sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083). | 28 |
| RA0083 Placebo Placebo (sodium chloride, 0.9%) was administered sc in Study RA0083, followed by switch to CDP6038 (olokizumab) 120 mg q2w sc at start of Study RA0089 (Week 12 of RA0083). | 24 |
| Total | 103 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 2 | 2 | 2 | 1 |
| Overall Study | Exclusion criteria | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Ineligibility reason | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Positive for purified protein derivative | 0 | 0 | 1 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 1 | 1 | 0 |
| Overall Study | Withdrawal criteria | 0 | 0 | 1 | 0 | 3 | 1 |
Baseline characteristics
| Characteristic | RA0083 CDP6038 (Olokizumab) 120 mg q2w | RA0083 CDP6038 (Olokizumab) 120 mg q4w | RA0083 CDP6038 (Olokizumab) 240 mg q4w | RA0083 CDP6038 (Olokizumab) 60 mg q2w | RA0083 CDP6038 (Olokizumab) 60 mg q4w | RA0083 Placebo | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 1 Participants | 2 Participants | 5 Participants | 6 Participants | 21 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 11 Participants | 10 Participants | 13 Participants | 23 Participants | 18 Participants | 82 Participants |
| Sex: Female, Male Female | 7 Participants | 12 Participants | 9 Participants | 12 Participants | 27 Participants | 21 Participants | 88 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 2 Participants | 3 Participants | 1 Participants | 3 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 15 | 0 / 11 | 0 / 15 | 0 / 28 | 0 / 24 |
| other Total, other adverse events | 8 / 10 | 13 / 15 | 10 / 11 | 12 / 15 | 25 / 28 | 21 / 24 |
| serious Total, serious adverse events | 1 / 10 | 0 / 15 | 2 / 11 | 2 / 15 | 5 / 28 | 4 / 24 |
Outcome results
Primary
Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
Reported TEAEs included adverse events that started or worsened after the first dose of CDP6038 (olokizumab) in Study RA0089 and within 30 days after the last dose.
Time frame: From Baseline (Week 0 of Study RA0089) until 30 days after the last dose (maximum up to 562 days)
Population: Safety Population included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) in Study RA0089.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | 8 Participants |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | 13 Participants |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | 10 Participants |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | 12 Participants |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | 25 Participants |
| RA0083 Placebo | Total Number of Subjects With Treatment-emergent Adverse Events (TEAEs) | 22 Participants |
Secondary
Change From Baseline (Week 0 of Study RA0083) CDAI at Week 96 of Study RA0089
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Secondary
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Time frame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089 | -2.6916 units on a scale | Standard Deviation 0.75807 |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089 | -3.3277 units on a scale | Standard Deviation 1.05841 |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089 | -3.3523 units on a scale | Standard Deviation 0.74516 |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089 | -2.8884 units on a scale | Standard Deviation 1.43276 |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089 | -3.0176 units on a scale | Standard Deviation 0.82217 |
| RA0083 Placebo | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 24 of Study RA0089 | -2.8235 units on a scale | Standard Deviation 0.99271 |
Secondary
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089 | -2.6243 units on a scale | Standard Deviation 1.52735 |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089 | -3.2720 units on a scale | Standard Deviation 0.97343 |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089 | -3.2397 units on a scale | Standard Deviation 0.85356 |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089 | -2.9625 units on a scale | Standard Deviation 1.16236 |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089 | -2.4750 units on a scale | Standard Deviation 1.31771 |
| RA0083 Placebo | Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 48 of Study RA0089 | -3.2211 units on a scale | Standard Deviation 0.45471 |
Secondary
Change From Baseline (Week 0 of Study RA0083) in DAS28(CRP) at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no results data are available for analysis at the Week 96 time point and this Outcome Measure has zero total participants analyzed.
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Secondary
Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089
CDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS and PhGADA-VAS, according to the following formula: SJC + TJC + PtGADA + PhGADA Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. Total score range is from 0-100, with the high scores representing high disease activity. A negative change in CDAI score indicates an improvement in disease activity.
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089 | -72.0000 units on a scale | Standard Deviation 86.13362 |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089 | -108.0256 units on a scale | Standard Deviation 77.85787 |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089 | -95.1667 units on a scale | Standard Deviation 24.41652 |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089 | -75.2870 units on a scale | Standard Deviation 46.83603 |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089 | -94.7363 units on a scale | Standard Deviation 54.63562 |
| RA0083 Placebo | Change From Baseline (Week 0 of Study RA0083) in the Clinical Disease Activity Index (CDAI) at Week 48 of Study RA0089 | -99.9744 units on a scale | Standard Deviation 41.83169 |
Secondary
Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089
DAS28(CRP) was calculated using tender/painful joint count (TJC) and swollen joint count (SJC) from 28 joints, Patient's Global Assessment of Disease Activity (PtGADA)-Visual Analog Scale (VAS), and CRP as per formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: •TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. 28 joints included shoulders, elbows, wrists; metacarpophalangeal (MCP), thumb interphalangeal (IP), and proximal interphalangeal (PIP) joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores greater than (\>) 5.1 correspond with active disease, scores less than (\<) 3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. A negative change in DAS28(CRP) score indicates an improvement in disease activity.
Time frame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
Population: Full Analysis Set (FAS) included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089 | -2.9618 units on a scale | Standard Deviation 1.05692 |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089 | -2.5358 units on a scale | Standard Deviation 1.1155 |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089 | -2.9758 units on a scale | Standard Deviation 1.23346 |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089 | -2.7948 units on a scale | Standard Deviation 1.28792 |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089 | -2.6837 units on a scale | Standard Deviation 0.80614 |
| RA0083 Placebo | Change From Baseline (Week 0 of Study RA0083) in the Disease Activity Score-28-joint Count (C-reactive Protein) (DAS28[CRP]) at Week 12 of Study RA0089 | -2.5902 units on a scale | Standard Deviation 1.06296 |
Secondary
Change From Baseline (Week 0 of Study RA0083) in the SDAI at Week 96 of Study RA0089
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL\]), as per formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Secondary
Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089
SDAI was calculated using the TJC (28 joints), SJC (28 joints), PtGADA-VAS, PhGADA-VAS and CRP (mg/dL\]), according to the following formula: SJC + TJC + PtGADA + PhGADA + CRP (mg/dL) Assessments: • TJC and SJC: assessed on the same 2-point scale (0=absent; 1=present). • PtGADA: 10 cm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • PhGADA: 10 cm VAS (0=very good, asymptomatic and no limitation of normal activities; 100=very poor, very severe symptoms which were intolerable and inability to carry out all normal activities). • CRP range was from 0 to 10 mg/dL. The 28 joints included the shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of the hands; and the knees. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. A negative change in SDAI score indicates an improvement in disease activity.
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089. Here, number of participants analyzed included all participants who were evaluable for this outcome measure (assessed at Baseline and postbaseline timepoint).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089 | -75.6667 units on a scale | Standard Deviation 90.23488 |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089 | -130.6923 units on a scale | Standard Deviation 97.08073 |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089 | -125.1667 units on a scale | Standard Deviation 48.85659 |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089 | -93.7870 units on a scale | Standard Deviation 61.2355 |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089 | -113.3077 units on a scale | Standard Deviation 53.87161 |
| RA0083 Placebo | Change From Baseline (Week 0 of Study RA0083) in the Simplified Disease Activity Index (SDAI) at Week 48 of Study RA0089 | -127.8633 units on a scale | Standard Deviation 38.49694 |
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported.
Time frame: Week 12 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089 | 50.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089 | 64.29 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089 | 70.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089 | 53.85 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089 | 43.48 Percentage of subjects |
| RA0083 Placebo | Percentage of Subjects With DAS28(CRP) <2.6 at Week 12 of Study RA0089 | 39.13 Percentage of subjects |
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported.
Time frame: Week 24 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089 | 50.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089 | 77.78 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089 | 80.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089 | 54.55 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089 | 59.09 Percentage of subjects |
| RA0083 Placebo | Percentage of Subjects With DAS28(CRP) <2.6 at Week 24 of Study RA0089 | 40.91 Percentage of subjects |
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported.
Time frame: Week 48 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089 | 66.67 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089 | 100.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089 | 83.33 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089 | 100.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089 | 42.86 Percentage of subjects |
| RA0083 Placebo | Percentage of Subjects With DAS28(CRP) <2.6 at Week 48 of Study RA0089 | 55.56 Percentage of subjects |
Secondary
Percentage of Subjects With DAS28(CRP) <2.6 at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) \<2.6 were reported. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Time frame: Week 96 (Study RA0089)
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) less than or equal to (≤) 3.2 were reported.
Time frame: Week 12 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089 | 100.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089 | 71.43 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089 | 80.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089 | 69.23 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089 | 78.26 Percentage of subjects |
| RA0083 Placebo | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 12 of Study RA0089 | 65.22 Percentage of subjects |
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
Time frame: Week 24 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089 | 87.50 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089 | 100.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089 | 90.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089 | 81.82 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089 | 72.73 Percentage of subjects |
| RA0083 Placebo | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 24 of Study RA0089 | 77.27 Percentage of subjects |
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Percentage of participants with DAS28(CRP) ≤3.2 were reported.
Time frame: Week 48 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089 | 66.67 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089 | 100.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089 | 100.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089 | 100.00 Percentage of subjects |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089 | 71.43 Percentage of subjects |
| RA0083 Placebo | Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 48 of Study RA0089 | 77.78 Percentage of subjects |
Secondary
Percentage of Subjects With DAS28(CRP) ≤3.2 at Week 96 of Study RA0089
DAS28(CRP) was calculated using the TJC and SJC from 28 joints, the PtGADA-VAS, andCRP according to the formula: DAS28(CRP)=0.56 \* (TJC)\^1/2 + 0.28 \* (SJC)\^1/2 + 0.36 \* ln(CRP\[mg/L\]+1) + 0.014 \* PtGADA + 0.96 Assessments: • TJC and SJC: assessed on same 2-point scale (0=absent; 1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms; 100=very poor, severe symptoms). • CRP value calculated in mg/L. The 28 joints included shoulders, elbows, wrists; MCP, thumb IP, and PIP joints of hands; and knees. Scores on DAS28(CRP) range from 0 to approximately 10, where scores \>5.1 correspond with active disease, scores \<3.2 correspond with well controlled disease, and scores \<2.6 correspond with remission or similar. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Time frame: Week 96 (Study RA0089)
Secondary
Plasma Concentration of Anti-CDP6038 (Olokizumab) Antibodies at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96 and 120
The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Time frame: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Secondary
Plasma Concentration of CDP6038 (Olokizumab) at Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
The CDP6038 (olokizumab) plasma levels data were not collected and analyzed. This Outcome Measure therefore has zero total participants analyzed.
Time frame: Weeks 4, 8, 12, 16, 24, 32, 40, 48, 72, 96, 120
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 60.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 46.7 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 81.8 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 57.1 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 71.4 Percentage of responders |
| RA0083 Placebo | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 66.7 Percentage of responders |
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 20.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 13.3 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 54.5 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 21.4 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 21.4 Percentage of responders |
| RA0083 Placebo | The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 33.3 Percentage of responders |
Secondary
The ACR20 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR20: at least 20% improvement from Baseline in TJC (68 joints) + SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Secondary
The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 70.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 40.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 54.5 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 42.9 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 42.9 Percentage of responders |
| RA0083 Placebo | The ACR 50% (ACR50) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 50.0 Percentage of responders |
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 40.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 40.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 63.6 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 57.1 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 42.9 Percentage of responders |
| RA0083 Placebo | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 45.8 Percentage of responders |
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR50 represents at least 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 20.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 13.3 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 45.5 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 14.3 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 17.9 Percentage of responders |
| RA0083 Placebo | The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 29.2 Percentage of responders |
Secondary
The ACR50 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR50:atleast 50% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Secondary
The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 30.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 26.7 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 27.3 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 21.4 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 17.9 Percentage of responders |
| RA0083 Placebo | The ACR 70% (ACR70) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 29.2 Percentage of responders |
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 24 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 10.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 20.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 54.5 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 42.9 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 32.1 Percentage of responders |
| RA0083 Placebo | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 24 of Study RA0089 | 25.0 Percentage of responders |
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089
ACR70 represents at least 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 48 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 10.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 13.3 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 18.2 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 14.3 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 7.1 Percentage of responders |
| RA0083 Placebo | The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 48 of Study RA0089 | 16.7 Percentage of responders |
Secondary
The ACR70 Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 96 of Study RA0089
ACR70:atleast 70% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, PhGADA-VAS, PAAP-VAS, HAQ-DI and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status. Since the study was terminated early before Week 96, no data was collected and analyzed at the Week 96 and this Outcome Measure has zero total participants analyzed.
Time frame: Baseline (Week 0 of Study RA0083) and Week 96 (Study RA0089)
Secondary
The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089
ACR20 represents at least 20% improvement from Baseline in TJC (68 joints) + in SJC (66 joints) + in at least 3 of 5 core set measures: PtGADA-VAS, Physician's Global Assessment of Disease Activity (PhGADA)-VAS, Patient's Assessment of Arthritis Pain (PAAP)-VAS, Health Assessment Questionnaire-Disability Index (HAQ-DI) and CRP. Assessments: • TJC and SJC: same 2-point scale (0=absent;1=present). • PtGADA: 100 mm VAS (0=very good, no symptoms;100=very poor, severe symptoms). • PhGADA: 100 mm VAS (0=very good, asymptomatic, no limitation of normal activities;100=very poor, very severe symptoms which were intolerable, inability to carry out all normal activities). • PAAP: 100 mm VAS (0=no pain;100=most severe pain). • HAQ-DI assessed degree of difficulty experienced in 8 domains of daily living activities (20 questions), total score (0-3) computed from item scores, with lower scores meaning less disability. • CRP in mg/L. Missing values were considered as non-responding status.
Time frame: Baseline (Week 0 of Study RA0083) and Week 12 (Study RA0089)
Population: FAS included all enrolled subjects who received at least 1 injection of CDP6038 (olokizumab) and in addition had at least 1 efficacy measurement in Study RA0089.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| RA0083 CDP6038 (Olokizumab) 120 mg q2w | The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 100.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 120 mg q4w | The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 60.0 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 240 mg q4w | The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 81.8 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q2w | The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 71.4 Percentage of responders |
| RA0083 CDP6038 (Olokizumab) 60 mg q4w | The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 64.3 Percentage of responders |
| RA0083 Placebo | The American College of Rheumatology (ACR) 20% (ACR20) Improvement Criteria Response Rate From Baseline (Week 0 of Study RA0083) at Week 12 of Study RA0089 | 70.8 Percentage of responders |