| Primary | Percentage of Participants With an American College of Rheumatology 20% (ACR20) C-Reactive Protein (CRP) Response at Week 12 | The ACR20 response required that all criteria from (1) to (3) below be met.
- Tender joint count (TJC) : ≥ 20% reduction compared with baseline.
- Swollen joint count (SJC) : ≥ 20% reduction compared with baseline.
- ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline
(3) ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, Subject's Global Assessment of Arthritis (SGA), Physician's Global Assessment of Arthritis (PGA), Health Assessment Questionnaire - Disability Index (HAQ-DI), C-Reactive Protein (CRP). | The analysis population consisted of the Full Analysis Set (FAS). Last observation carried forward (LOCF) was used. | Posted | | Number | | Percentage of Participants | | Baseline and Week 12/early termination (ET) | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
| | Units | Counts |
|---|
| Participants | - OG000101
- OG001104
- OG002102
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00030.7
- OG00157.7
- OG00274.5
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Treatment Difference vs Placebo | Wald's chi-squared test | | <0.001 | Closed testing procedure was used for multiplicity adjustment. Etanercept was open-label reference group and it was not included in statistical test. | Odds Ratio (OR) | 3.13 | | | 2-Sided | 95 | 1.76 | 5.58 | | | Based on logistic regression model: ACR20-CRP response (responder, non-responder) = Treatment + the prior biologic-DMARD-IR (No, Yes) + concomitant DMARD use (No, Yes) + study region (Japan, Korea, and Taiwan). | | Superiority | |
|
| Secondary | Percentage of Participants With an ACR20-CRP Response Through Week 52 | The ACR20 response required that all criteria from (1) to (3) below be met.
- TJC : ≥ 20% reduction compared with baseline.
- SJC : ≥ 20% reduction compared with baseline.
- ≥ 20% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
| FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Percentage of Participants With an American College of Rheumatology 50% (ACR50)-CRP Response at Week 12 | The ACR50 response required that all criteria from (1) to (3) below be met.
- TJC : ≥ 50% reduction compared with baseline.
- SJC : ≥ 50% reduction compared with baseline.
- ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
| | Posted | | Number | | Percentage of Participants | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Percentage of Participants With an ACR50-CRP Response Through Week 52 | The ACR50 response required that all criteria from (1) to (3) below be met.
- TJC : ≥ 50% reduction compared with baseline.
- SJC : ≥ 50% reduction compared with baseline.
- ≥ 50% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
| FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Percentage of Participants With an American College of Rheumatology 70% (ACR70)-CRP Response at Week 12 | The ACR70 response required that all criteria from (1) to (3) below be met.
- TJC : ≥ 70% reduction compared with baseline.
- SJC : ≥ 70% reduction compared with baseline.
- ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
| | Posted | | Number | | Percentage of Participants | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Percentage of Participants With an ACR70-CRP Response Through Week 52 | The ACR70 response required that all criteria from (1) to (3) below be met.
- TJC : ≥ 70% reduction compared with baseline.
- SJC : ≥ 70% reduction compared with baseline.
- ≥ 70% improvement in 3 or more of the following 5 parameters compared with baseline: Subject's assessment of pain, SGA, PGA, HAQ-DI, CRP.
| FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Change From Baseline in Disease Activity Score (DAS) 28-CRP at Week 12 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Change From Baseline DAS28-CRP Through Week 52 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. Higher DAS28 score indicated greater disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (ESR) at Week 12 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Change From Baseline in DAS28-ESR Through Week 52 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. Higher DAS28 score indicated greater disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | |
|
| Secondary | Change From Baseline in TJC (68 Joints) at Week 12 | The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Tender Joints | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
|
| Secondary | Change From Baseline in TJC (68 Joints) Through Week 52 | The following 68 joints subjects to assessment were examined for tender joints and the location was confirmed. Higher TJC68 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), hip joints (2), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | Tender Joints | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. |
|
| Secondary | Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Week 12 | The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Tender Joints | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
|
| Secondary | Change From Baseline in SJC (66 Joints) Through Week 52 | The following 66 joints subjects to assessment were examined for swollen joints and the location was confirmed. Higher SJC66 indicated greater disease activity. Temporomandibular joints (2), sternoclavicular joints (2), acromioclavicular joints (2), shoulder joints (2), elbow joints (2), wrist joints (2), distal interphalangeal joints (8), proximal interphalangeal joints of both hands (10), metacarpophalangeal joints (10), knee joints (2), ankle joints (2), tarsal bones (2), metatarsophalangeal joints (10), interphalangeal joint joints of toes (2), proximal interphalangeal joints of both feet (8). | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | Swollen Joints | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. |
|
| Secondary | Percentage of Participants Achieving DAS28-CRP < 2.6 at Week 12 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | |
|
| Secondary | Percentage of Participants Achieving DAS28-CRP < 2.6 Through Week 52 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Percentage of Participants Achieving DAS28-ESR < 2.6 at Week 12 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Percentage of Participants Achieving DAS28-ESR < 2.6 Through Week 52 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. If the DAS28 score was less than 2.6, the participant was considered to be in DAS28 remission. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Percentage of Participants Achieving DAS28-CRP <= 3.2 at Week 12 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | |
|
| Secondary | Percentage of Participants Achieving DAS28-CRP <= 3.2 Through Week 52 | DAS28-CRP response consisted of following parameters: TJC (28 joints), SJC (28 joints), CRP, SGA, and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.36 ln (CRP + 1) + 0.014 × SGA + 0.96. DAS28-CRP scores range from 0.96 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Percentage of Participants Achieving DAS28-ESR <= 3.2 at Week 12 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Percentage of Participants Achieving DAS28-ESR <= 3.2 Through Week 52 | DAS28-ESR response consisted of following parameters: TJC (28 joints), SJC (28 joints), ESR, SGA , and calculated according to below description. DAS28 = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 × SGA. DAS28-ESR scores range from 0 to approximately 10. DAS28 score of less than or equal to 3.2 was considered to be low disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Change From Baseline in CRP at Week 12 | Higher CRP indicates greater disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
| |
| Secondary | Change From Baseline in CRP Through Week 52 | Higher CRP indicates greater disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. | |
|
| Secondary | Change From Baseline in ESR at Week 12 | Higher ESR indicates greater disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | mm/hour | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
| |
| Secondary | Change From Baseline in ESR Through Week 52 | Higher ESR indicates greater disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | mm/hour | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. | |
|
| Secondary | Percentage of Participants With a European League Against Rheumatism (EULAR) Good Response Using DAS28-CRP at Week 12 | Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
| |
| Secondary | Percentage of Participants With a EULAR Good Response Using DAS28-CRP Through Week 52 | Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP at Week 12 | Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-CRP Through Week 52 | Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Percentage of Participants With a Good EULAR Response Using DAS28-ESR at Week 12 | Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
| |
| Secondary | Percentage of Participants With a Good EULAR Response Using DAS28-ESR Through Week 52 | Good response was defined as DAS28 after treatment ≤ 3.2 and improvement from baseline > 1.2. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR at Week 12 | Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Percentage of Participants With a Good or Moderate EULAR Response Using DAS28-ESR Through Week 52 | Good and moderate response was defined as DAS28 after treatment ≤ 5.1 and improvement from baseline > 0.6, or DAS28 after treatment > 5.1 and improvement from baseline > 1.2. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Percentage of Participants Achieving ACR / EULAR Remission at Week 12 | ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a visual analog scale (VAS) of 0 - 100 mm). Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Percentage of Participants Achieving ACR / EULAR Remission Through Week 52 | ACR/EULAR Remission was defined as TJC (68 joints) ≤ 1, SJC (66 joints) ≤ 1, CRP ≤ 1 mg/dL, and subject's global assessment of arthritis ≤ 1 cm (on a VAS of 0 - 100 mm). | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Remission at Week 12 | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks | | OG003 | Etanercept | |
|
| Secondary | Percentage of Participants Achieving SDAI Remission Through Week 52 | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. SDAI Remission was defined as SDAI score ≤ 3.3. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Change From Baseline in SDAI Score at Week 12 | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Change From Baseline in SDAI Score Through Week 52 | SDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, CRP (mg/dL), and calculated according to below description. SDAI = TJC + SJC + SGA + PGA + CRP. The SDAI score ranges from 0 to approximately 86. Higher SDAI indicates greater disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | |
|
| Secondary | Percentage of Participants Achieving Clinical Disease Activity Index (CDAI) Score <= 2.8 at Week 12 | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. Statistical analysis of treatment difference vs placebo was not estimable for either peficitinib 100 mg or peficitinib 150 mg reporting groups. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Number | | Percentage of Participants | | Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | |
|
| Secondary | Percentage of Participants Achieving CDAI Score <= 2.8 Through Week 52 | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. CDAI. Remission was defined as CDAI score ≤ 2.8. | FAS, number of participants with available data at each study visit. | Posted | | Number | | Percentage of Participants | | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Change From Baseline in CDAI Score at Week 12 | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Change From Baseline in CDAI Score Through Week 52 | CDAI score consisted of following parameters: TJC (28 joints), SJC (28 joints), SGA, PGA, and calculated according to below description. CDAI = TJC + SJC + SGA + PGA. The CDAI score ranges from 0 to approximately 76. Higher CDAI indicates greater disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | |
|
| Secondary | Change From Baseline in Physician's Global Assessment of Arthritis (PGA) at Week 12 | The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
|
| Secondary | Change From Baseline in PGA Through Week 52 | The investigator assessed the participants' disease activity on a VAS of 0-100 mm on the physician assessment table. Higher PGA (100 mm VAS) scores indicate greater activity impairment. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Change From Baseline in Subject's SGA at Week 12 | The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
| |
| Secondary | Change From Baseline in SGA Through Week 52 | The participant assessed his/her own disease activity on a VAS of 0-100 mm on the questionnaire form. Higher SGA (100 mm VAS) scores indicate greater activity impairment. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Change From Baseline in Subject's Assessment of Pain at Week 12 | The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
| |
| Secondary | Change From Baseline in Subject's Assessment of Pain Through Week 52 | The participant assessed his/her own pain severity on a VAS from 0-100 mm on the questionnaire form. Higher SGA of pain (100 mm VAS) scores indicate greater activity pain. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 150 mg/day from week 12 to week 52. |
|
| Secondary | Number of Participants Who Withdrew Due to Lack of Efficacy | The number of participants who withdrew due to lack of efficacy up to week 12 was calculated. | Initial Randomization Set | Posted | | Count of Participants | | Participants | | Up to week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept | Participants were administered 50 mg of subcutaneous etanercept once weekly for 52 weeks. |
| |
| Secondary | Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 12 | The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG003 | Etanercept |
|
| Secondary | Change From Baseline in HAQ-DI Through Week 52 | The HAQ-DI (range 0 - 3) was composed of 20 items in 8 categories (Dressing and Grooming, Arising, Eating, Walking, Hygiene, Reach, Grip, and Activities). Each category has at least two questions. Within each category, participants reported the amount of difficulty they have in performing the specific question items. Higher HAQ-DI score indicates greater disease activity. | FAS, number of participants with available data at each study visit. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. | | OG003 | Placebo / Peficitinib 150 mg |
|
| Secondary | Change From Baseline in Short Form Health Survey - 36 Questions, Version 2 (SF-36v2) Physical Component Summary Score at Week 12 | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 m | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
|
| Secondary | Change From Baseline in SF-36v2 Physical Component Summary Score Through Week 52 | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. | FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 4, 8, 12, 28, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | |
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| Secondary | Change From Baseline in SF-36v2 Mental Component Summary Score at Week 12 | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
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| Secondary | Change From Baseline in SF-36v2 Mental Component Summary Score Through Week 52 | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. | FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline and Week 4, 8, 12, 28, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | |
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| Secondary | Change From Baseline in SF-36v2 Role/Social Component Summary Score at Week 12 | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
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| Secondary | Change From Baseline in SF-36v2 Role/Social Component Summary Score Through Week 52 | The SF-36v2 was scored for the 8 subscales (each range: 0-100 scale): 1. physical functioning, 2. role physical, 3. bodily pain, 4. general health, 5. vitality, 6. social functioning, 7. role-emotional, and 8. mental health. Physical Component Summary Score, Mental Component Summary Score and Roll/Social Component Summary Score were calculated based on the 2007 General Japanese Population Means and Standard Deviations and coefficient. Component summary measures had means of 50 in 2007 General Japanese Population and deviation was expressed by the scale of 10. Higher score indicated better health state. | FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the SF-36 questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline and Week 4, 8, 12, 28, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | |
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| Secondary | Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Percent Work Time Missed at Week 12 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Percent Work Time | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
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| Secondary | Change From Baseline in WPAI Percent Work Time Missed Through Week 52 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent work time missed due to problem: Q2/(Q2+Q4). | FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib. | Posted | | Mean | Standard Deviation | Percent Work Time | | Baseline and Week 4, 8, 12, 28, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Etanercept |
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| Secondary | Change From Baseline in WPAI Percent Impairment While Working at Week 12 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Percent Impairment | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
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| Secondary | Change From Baseline in WPAI Percent Impairment While Working Through Week 52 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent impairment while working due to problem: Q5/10. | FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib. | Posted | | Mean | Standard Deviation | percent impairment | | Baseline and Week 4, 8, 12, 28, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 |
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| Secondary | Change From Baseline in Percent Overall Work Impairment at Week 12 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Percent iImpairment | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
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| Secondary | Change From Baseline in WPAI Percent Overall Work Impairment Through Week 52 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent overall work impairment due to problem: Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)]. | FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib. | Posted | | Mean | Standard Deviation | Percent Impairment | | Baseline and Week 4, 8, 12, 28, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 |
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| Secondary | Change From Baseline in WPAI Percent Activity Impairment at Week 12 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. | FAS, number of participants with both baseline and available post-baseline data up to week 12. LOCF was used. | Posted | | Mean | Standard Deviation | Percent Impairment | | Baseline and Week 12/ET | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
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| Secondary | Change From Baseline in WPAI Percent Activity Impairment Through Week 52 | WPAI consisted of 6 questions (Q1=Employment status; Q2=Hours absent from work due to the rheumatoid arthritis; Q3=Hours absent from work due to other reasons; Q4=Hours actually worked; Q5=Impact of the rheumatoid arthritis on productivity while working; Q6=Impact of the rheumatoid arthritis on productivity while doing regular daily activities other than work) and a 1-week recall period. Higher WPAI scores indicate greater activity impairment. Multiply scores by 100 to express in percentages. Percent activity impairment due to problem: Q6/10. | FAS, number of participants with available data at each study visit. The focus of data collection after Week 12 for participants transitioned from Placebo to Peficitinib was safety. Long term efficacy was not evaluated by the WPAI questionnaire for them. These assessments were only conducted at Weeks 28 and 52 after transitioning to Peficitinib. | Posted | | Mean | Standard Deviation | percent impairment | | Baseline and Week 4, 8, 12, 28, and 52 | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Etanercept |
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| Secondary | Number of Participants With Adverse Events During the First 12 Weeks | Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by System Organ Class (SOC) and Preferred Term (PT). Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. | | Posted | | Count of Participants | | Participants | | Week 0 to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants were assigned to receive placebo to peficitinib once a day until week 12. | | OG001 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG002 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. |
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| Secondary | Number of Participants With Adverse Events From Week 12 | Treatment-emergent adverse events (TEAEs) were defined as any AE that started or worsened in severity after initial dose of study drug or reference drug through week 52 or withdrawal. TEAEs were summarized using MedDRA (Version 11.1) by SOC and PT. Participants reporting more than 1 AE for a given MedDRA PT were counted only once for that term. Participants reporting more than 1 AE within a SOC were counted only once for the SOC total. Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) grade: grade 3 = severe or medically significant, grade 4 = life threatening, grade 5 = death related to AE. | | Posted | | Count of Participants | | Participants | | Week 12 to week 52, plus 28 days after the week 52 visit for participants who did not enroll in the extension study | | | | ID | Title | Description |
|---|
| OG000 | Peficitinib 100 mg | Participants were assigned to receive peficitinib 100 mg/day for 52 weeks. | | OG001 | Peficitinib 150 mg | Participants were assigned to receive peficitinib 150 mg/day for 52 weeks. | | OG002 | Placebo / Peficitinib 100 mg | Participants were assigned to receive placebo to peficitinib once a day until week 12 and peficitinib 100 mg/day from week 12 to week 52. |
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