| Primary | Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88 | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than [<]20 percent [%] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity. | Modified Intent to Treat population (mITT): all participants who took at least 1 dose of double-blind test article and had at least 1 post-randomization DAS28 evaluation | Posted | | Number | | percentage of participants | | Week 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00082.6
- OG00179.1
- OG00242.6
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| | 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 |
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| Sample size estimated based on moderate/severe rheumatoid arthritis(RA) trial. Study design included only moderate RA participants, thus a low disease activity estimate of 85% (ETN+MTX) vs 70% (MTX only) assumed, required 175 randomized participants in 3 treatments for a 90% power and Type I error of 0.05 to reject the null hypothesis of no ETN+MTX vs MTX only differences. More participants qualified for Period 2 than expected, Period 2 sample size roughly 15% larger than protocol-specified. | Cochran-Mantel-Haenszel | Loss of efficacy (LOE) imputation defined as LOE drop-outs were treated as non-responders/all other participants had LOCF applied as primary analysis. | <0.0001 | P-value from Cochran-Mantel-Haenszel(CMH) test of general association, testing treatment effect on response. P-value and Odds Ratio (OR) stratified by geographic region. | Odds Ratio (OR) | 5.36 | | | 2-Sided | 95 | 3.2 | 9.0 |
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| Secondary | Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36 | DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission. | Period 1 Modified Intent to Treat population (P1 mITT): all participants who took at least 1 dose of open-label test article; N=number of participants with evaluable data; Last observation carried forward (LOCF) | Posted | | Number | | percentage of participants | | Baseline, Weeks 4, 8, 12, 20, 28, 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Percentage of Participants Achieving DAS28 Low Disease Activity or Remission | DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 < 2.6 units = remission. | | Posted | | Number | | Percentage of participants | | Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 |
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| Secondary | Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36 | The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and patient's global assessment (PGA) of disease activity measured on a visual analogue scale (VAS) of 100 mm). Change equals (=) Week X observation minus (-) Baseline observation. | P1 mITT; Last observation carried forward (LOCF); N=Number of participants with evaluable data | Posted | | Mean | Standard Error | units on a scale | | Baseline, Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88 | The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). Change = Week X observation - Week 36 observation. | P2 mITT; LOCF; N=number of participants with evaluable data | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 |
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| Secondary | Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28 | DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. Low disease activity = DAS28 ≤ 3.2 units. DAS28 > 3.2 to 5.1 units = moderate to high disease activity. | P2 mITT;Imputation of failure; observed cases | Posted | | Median | 95% Confidence Interval | days | | Week 36 up to Week 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 |
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| Secondary | Time to Loss of Low Disease Activity DAS28 | DAS28 calculated from the number of SJC and PJC using the 28 joints count, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units = low disease activity, DAS28 greater than (>)3.2 to 5.1 units = moderate to high disease activity. | | Posted | | Median | 95% Confidence Interval | days | | Week 36 up to Week 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 |
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| Secondary | Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88 | DAS28 calculated from the number of SJC and PJC using the 28 joints, the ESR mm/hour and Patient's General Health VAS. VAS consisted of a line 0 to 100 mm in length; ranged from 0 (very well) to 100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 < 3.2 units = low disease activity. Cumulative proportion calculated as time-averaged Area Under the Curve (AUC) (AUC divided by number of weeks at that time point), with AUC calculated from Week 36 and Week 88. | | Posted | | Mean | Standard Error | proportion of weeks in DAS28 <3.2 | | Week 36 up to Week 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36 | American College of Rheumatology (ACR), swollen joint count were an assessment of 28 joints. Joints are classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - baseline observation. | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Mean | Standard Error | number of swollen joints | | Baseline, Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Prorated Swollen Joint Count at Week 36 | ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by number of non-missing swollen joints). Total possible score of swollen joints ranged from 0-28. | | Posted | | Mean | Standard Error | number of swollen joints | | Week 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88 | ACR, swollen joint count was an assessment of 28 joints. Joints were classified as either swollen or not swollen. If < 20% of swollen joints missing then total swollen joint prorated (multiplied by 28 divided by (/) number of non-missing swollen joints). Total possible score ranged from -28 to 28. An increase in swollen joints from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation. | | Posted | | Least Squares Mean | Standard Error | number of swollen joints | | Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36 | A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Baseline observation. | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Mean | Standard Error | number of painful joints | | Baseline, Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Painful Joint Count at Week 36 | A total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible score ranged form 0-28. | | Posted | | Mean | Standard Error | number of painful joints | | Week 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88 | Total of 28 joints were assessed by the investigator using criteria based on pressure and joint manipulation. Total possible scores ranged from -28 to 28. An increase in joint pain count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression and a decrease represented improvement. Change = Week X observation - Week 36 observation. | P2 mITT; N=number of participants with evaluable data; LOCF | Posted | | Least Squares Mean | Standard Error | number of painful joints | | Weeks 36 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 |
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| Secondary | Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36 | PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Baseline observation. | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Mean | Standard Error | units on a scale | | Baseline, Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | PGA Score at Week 36 | PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. | | Posted | | Mean | Standard Error | units on a scale | | Week 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88 | PGA of Disease Activity was measured on a 0 to 10 Scale, with 0 = no disease activity and 10 = extreme disease activity. Change = Week X observation - Week 36 observation. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36 | Participants asked to rate their overall arthritis activity by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Baseline observation. | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Mean | Standard Error | units on a scale | | Baseline, Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | PtGA of Arthritis Pain at Week 36 | PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). | | Posted | | Mean | Standard Error | units on a scale | | Week 36 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88 | PtGA asked the participant to assess their overall arthritis activity. Participants responded by circling a number ranging from 0 (no disease activity) to 10 (extreme disease activity). Change = Week X observation - Week 36 observation. | | Posted | | Least Squares Mean | Standard Error | units on a scale | | Weeks 36, 40, 48, 56, 64, 72, 80, 88 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36 | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour times [*] 60 min) was recorded. Change = Week X observation - Baseline observation. | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Mean | Standard Deviation | minutes (min) | | Baseline, Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Duration of Morning Stiffness at Week 36 | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and when the participants were able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded. | P2 mITT; N=number of participants with evaluable data; LOCF | Posted | | Mean | Standard Error | min | | Week 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88 | Duration of morning stiffness was defined as the time elapsed when participant woke up in the morning and was able to resume normal activities without stiffness. No stiffness present = 0; stiffness persisted the entire day = 1440 minutes (24 hour * 60 min) was recorded. Change = Week X observation - Week 36 observation. | P2 mITT; N=number of participants with evaluable data; LOCF | Posted | | Least Squares Mean | Standard Error | min | | Weeks 36, 40, 48, 56, 64, 72, 80, 88 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | |
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| Secondary | Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36 | General Health VAS is a 100 millimeter (mm) line marked by the participant. Participants were asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Baseline observation. | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Mean | Standard Deviation | mm | | Baseline, Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
|---|
| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | General Health at Week 36 | General Health VAS is a 100 mm line marked by the participant. Participants are asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad. | | Posted | | Mean | Standard Error | mm | | Week 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88 | General Health VAS is a 100 mm line marked by the participant. Participants were asked, "In general how would you rate your health over the last 2 to 3 weeks?" Scores ranged from 0 mm = very well to 100 mm = extremely bad. Change = Week X observation - Week 36 observation. | P2 mITT; N=number of participants with evaluable data; LOCF | Posted | | Least Squares Mean | Standard Error | mm | | Weeks 36, 40, 48, 56, 64, 72, 80, 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36 | 100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Baseline observation. | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Mean | Standard Error | mm | | Baseline, Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Pain at Week 36 | 100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = pain as bad as it could be. Change = Week x observation minus (-) Baseline observation. | | Posted | | Mean | Standard Error | mm | | Week 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88 | 100 mm line (Visual Analog Scale) marked by participant. Intensity of pain range (over past 2 to 3 days): 0 = no pain to 100 = worst possible pain. Change = Week X observation - Week 36 observation. | | Posted | | Least Squares Mean | Standard Error | mm | | Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36 | PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?). | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | 95% Confidence Interval | percentage of participants | | Baseline, Week 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88 | PASS was a 1 question assessment of how rheumatoid arthritis has affected the participant in the last 2 days (If you were to remain in the next few months as you were during the last 2 days, would this be acceptable or unacceptable to you?). | P2 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | | percentage of participants | | Weeks 36, 64 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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| Secondary | Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36 | EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response. | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88 | EULAR Response Criteria: Good response was defined as >1.2 units improvement in DAS28 from Baseline and DAS28 attained up to Week 88 of <=3.2 units. Non responders were participants with improvement of <0.6 units or participants with improvement of 0.6 to 1.2 units and DAS28 attained up to Week 88 of > 5.1 units. Remaining participants were defined as having a moderate response. Scores of good and moderate were considered to have therapeutic response. | P2 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | | percentage of participants | | Week 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | |
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| Secondary | Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36 | ACR20 response, ≥ 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and = at least 20% improvement in at least 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and acute phase reactant (ESR). | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | ACR20 response: ≥ 20% improvement in tender joint count; ≥20% improvement in swollen joint count; and = at least 20% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR). | P2 mITT; LOCF; N=number of participants with evaluable data | Posted | | Number | | percentage of participants | | Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 |
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| Secondary | Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36 | ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR). | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | ACR50 response: ≥ 50% improvement in tender joint count; = ≥50% improvement in swollen joint count; and = at least 50% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR). | P2 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | | percentage of participants | | Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 |
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| Secondary | Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36 | ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR). | P1 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | ACR70 response: ≥ 70% improvement in tender joint count; = ≥70% improvement in swollen joint count; and = at least 70% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and C-Reactive Protein CRP. | P2 mITT; N=number of participants with evaluable data; LOCF | Posted | | Number | | percentage of participants | | Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 |
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| Secondary | Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36 | ACR90 response: ≥ 90% improvement in tender joint count; = ≥90% improvement in swollen joint count; and = at least 90% improvement in 3 of the following 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR). | | Posted | | Number | | percentage of participants | | Weeks 4, 8, 12, 20, 28 and 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1 | Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks. |
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| Secondary | Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | ACR90 response: ≥ 90% improvement in tender joint count; = 90% improvement in swollen joint count; and = 90% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the HAQ); and acute phase reactant (ESR). | | Posted | | Number | | percentage of participants | | Weeks 36, 40, 48, 56, 64, 72, 80 and 88 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 |
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| Secondary | DAS28 at Week 36 | The DAS28 is a score on a scale (0 to 10) indicating current activity of rheumatoid arthritis (>5.1=high disease activity; <=3.2=low disease activity; <2.6=remission); a continuous variable which is a composite of 4 variables (the number of tender joints out of 28, the number of swollen joints out of 28 joints, ESR mm/hour and PGA of disease activity measured on a VAS of 100 mm). | | Posted | | Mean | Standard Error | units on a scale | | Week 36 | | | | ID | Title | Description |
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| OG000 | Etanercept 50 mg Plus MTX -Period 2 | Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG001 | Etanercept 25 mg Plus MTX-Period 2 | Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. | | OG002 | Placebo Plus MTX-Period 2 | Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36. |
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