Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid Arthritis, Arthritis
Brief summary
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
Interventions
DRUGEtanercept
10 mg twice weekly, subcutaneous injection for 52 weeks
DRUGMethotrexate
up to 8 mg per week, oral dosing for 52 weeks
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Must be Japanese and live in Japan * Must be age 20 to 75 years * Diagnosed less than or equal to 10 years from time of first visit
Exclusion criteria
* Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab in the past * Patient with other rheumatic diseases or conditions that could predispose the patient to infection * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 | Week 52 | mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | Week 24 | mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement. |
| Change From Baseline in Erosion Score at Weeks 24 and 52 | Baseline, Week 24, and Week 52 | Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 | Baseline, Week 24, and Week 52 | JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Percentage of Participants With no Progression of Joint Destruction at Week 52 | Baseline and Week 52 | Absence of joint destruction defined by 3 categories (mTSS change \<=0.5, \<=3.0, and \<smallest detectable difference \[SDD\] where SDDs were scores \>3.0). mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). |
| Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | American College of Rheumatology (ACR) swollen joint count was an assessment of 68 joints. Joints classified as either swollen or not swollen. Change = scores at observation minus score at Baseline, and total possible scores ranged from -68 to 68. 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 From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | 71 joints assessed by the investigator using criteria based on pressure and joint manipulation. Change = scores at observation minus score at Baseline, and total possible scores ranged from -71 to 71. An increase in tender joint count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Physician Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Patient's Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Morning stiffness in and around the joints lasting at least 1 hour before maximal improvement. Change = scores at observation minus score at Baseline. An increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | 100mm line (VAS) marked by participant. Participants asked, In general how would you rate your health over the last 2-3 weeks? 0mm=very well to 100mm=extremely bad. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Change = scores at observation minus score at Baseline and total possible scores ranged from -3 to 3. An increase in score from baseline represented disease progression and/or joint worsening and a decrease represented improvement. |
| Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% 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 Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP). |
| Percentage of Participants With an ACR50 Response | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | ACR50 response: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% 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 CRP. |
| Percentage of Participants With an ACR70 Response | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | ACR70 response: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% 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 CRP. |
| Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | DAS: weighted calculation of joint tenderness score (Ritchie Articular Index\[RAI\]), swollen joint count of 44 joints, natural logarithm (ln) of erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using VAS. RAI defined as sum of 26 possible 0 to 3 tender scores. DAS = 0.53938 square root (√) (RAI) + 0.06465 (swollen joint count) + 0.330 (ln ESR) + 0.00722 (GH). Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome). |
| Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | DAS based on 28 painful joint counts, 28 swollen joint counts, ESR, and GH. DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH. Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome). |
| Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | CRP: marker of inflammation. Higher level consistent with inflammation. Normal CRP range: 0 to 1.0 milligrams per deciliter (mg/dL). |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation. |
| Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | 100 millimeter (mm) line (VAS) marked by participant. Intensity of pain range (over past week): 0mm = no pain to 100mm = worst possible pain. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
Other
| Measure | Time frame |
|---|---|
| Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses | Weeks 12, 24, 52 |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Methotrexate Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly | 176 |
| Etanercept 10 mg Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks | 192 |
| Etanercept 25 mg Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks | 182 |
| Total | 550 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 9 | 15 | 19 |
| Overall Study | Lack of Efficacy | 38 | 13 | 6 |
| Overall Study | Lost to Follow-up | 0 | 2 | 0 |
| Overall Study | Other | 6 | 5 | 6 |
Baseline characteristics
| Characteristic | Methotrexate | Etanercept 10 mg | Etanercept 25 mg | Total |
|---|---|---|---|---|
| Age Continuous | 50.40 years STANDARD_DEVIATION 11.91 | 51.46 years STANDARD_DEVIATION 12.21 | 51.81 years STANDARD_DEVIATION 11.07 | 51.24 years STANDARD_DEVIATION 11.74 |
| Erosion Score | 25.09 scores on a scale STANDARD_DEVIATION 26.3 | 26.66 scores on a scale STANDARD_DEVIATION 22.1 | 25.23 scores on a scale STANDARD_DEVIATION 23.88 | 25.69 scores on a scale STANDARD_DEVIATION 24.05 |
| Joint Space Narrowing (JSN) Score | 17.92 scores on a scale STANDARD_DEVIATION 21.93 | 18.50 scores on a scale STANDARD_DEVIATION 19.14 | 16.75 scores on a scale STANDARD_DEVIATION 19.11 | 17.73 scores on a scale STANDARD_DEVIATION 20.03 |
| modified Total Sharp Score (mTSS) | 43.01 scores on a scale STANDARD_DEVIATION 46.78 | 45.17 scores on a scale STANDARD_DEVIATION 38.75 | 41.98 scores on a scale STANDARD_DEVIATION 41.51 | 43.42 scores on a scale STANDARD_DEVIATION 42.28 |
| Sex: Female, Male Female | 140 Participants | 154 Participants | 145 Participants | 439 Participants |
| Sex: Female, Male Male | 36 Participants | 38 Participants | 37 Participants | 111 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 92 / 176 | 106 / 192 | 102 / 182 |
| serious Total, serious adverse events | 10 / 176 | 8 / 192 | 11 / 182 |
Outcome results
Primary
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time frame: Week 52
Population: Radiographic intent-to-treat (rITT) population: all participants who received at least 1 dose of the assigned test article and provided radiographic data for baseline and at least 1 post-baseline visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 | 9.82 Scores on a scale | Standard Error 1.16 |
| Etanercept 10 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 | 5.19 Scores on a scale | Standard Error 0.93 |
| Etanercept 25 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 | 3.33 Scores on a scale | Standard Error 0.73 |
Comparison: It was estimated that with 180 participants per group, there would be 81% power for the overall test. With this sample size and 0.05 (2-sided) type I error, there was 88% power to detect a 1.33 difference for the change of mTSS from baseline to 52 weeks between the etanercept 25 mg twice weekly group and Methotrexate group, assuming that the common standard deviation of the change of mTSS from baseline was 4.p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
p-value: 0.2634ANCOVA
Secondary
Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
CRP: marker of inflammation. Higher level consistent with inflammation. Normal CRP range: 0 to 1.0 milligrams per deciliter (mg/dL).
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -6.23 mg/dL | Standard Deviation 22.16 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -3.08 mg/dL | Standard Deviation 13.08 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -3.25 mg/dL | Standard Deviation 15.82 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -4.19 mg/dL | Standard Deviation 17.81 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -7.30 mg/dL | Standard Deviation 18 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -6.51 mg/dL | Standard Deviation 19.28 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -7.18 mg/dL | Standard Deviation 21.29 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -6.31 mg/dL | Standard Deviation 21.74 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -6.41 mg/dL | Standard Deviation 21.68 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -6.34 mg/dL | Standard Deviation 22.18 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -5.20 mg/dL | Standard Deviation 22.55 |
| Methotrexate | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 21.13 mg/dL | Standard Deviation 22.3 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -12.90 mg/dL | Standard Deviation 22.96 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 22.86 mg/dL | Standard Deviation 29.77 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -12.21 mg/dL | Standard Deviation 22.31 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -13.45 mg/dL | Standard Deviation 21.76 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -13.41 mg/dL | Standard Deviation 19.53 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -13.31 mg/dL | Standard Deviation 20.73 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -13.13 mg/dL | Standard Deviation 22.47 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -11.05 mg/dL | Standard Deviation 17.73 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -13.04 mg/dL | Standard Deviation 20.48 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -13.69 mg/dL | Standard Deviation 21.26 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -13.18 mg/dL | Standard Deviation 20.74 |
| Etanercept 10 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -13.01 mg/dL | Standard Deviation 22.03 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -15.17 mg/dL | Standard Deviation 19.05 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -14.87 mg/dL | Standard Deviation 20.36 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -15.15 mg/dL | Standard Deviation 20.82 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -15.73 mg/dL | Standard Deviation 22.44 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -15.86 mg/dL | Standard Deviation 20.23 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -16.10 mg/dL | Standard Deviation 21.38 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -16.28 mg/dL | Standard Deviation 21.25 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 22.09 mg/dL | Standard Deviation 24.17 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -15.62 mg/dL | Standard Deviation 17.7 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -13.33 mg/dL | Standard Deviation 16.58 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -15.38 mg/dL | Standard Deviation 21.8 |
| Etanercept 25 mg | Change From Baseline in C-reactive Protein (CRP) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -15.08 mg/dL | Standard Deviation 22.29 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.0442ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.0681ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.0966ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.0006ANCOVA
Comparison: Week 12p-value: 0.1242ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: <0.001ANCOVA
Comparison: Week 16p-value: 0.1521ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.007ANCOVA
Comparison: Week 20p-value: 0.014ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.0815ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.0002ANCOVA
Comparison: Week 32p-value: 0.0886ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.0003ANCOVA
Comparison: Week 40p-value: 0.1488ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.0006ANCOVA
Comparison: Week 48p-value: 0.0979ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.0001ANCOVA
Comparison: Week 52p-value: 0.174ANCOVA
Secondary
Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
DAS: weighted calculation of joint tenderness score (Ritchie Articular Index\[RAI\]), swollen joint count of 44 joints, natural logarithm (ln) of erythrocyte sedimentation rate (ESR) in millimeters per hour (mm/hr), and general health (GH) using VAS. RAI defined as sum of 26 possible 0 to 3 tender scores. DAS = 0.53938 square root (√) (RAI) + 0.06465 (swollen joint count) + 0.330 (ln ESR) + 0.00722 (GH). Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -1.42 Scores on a scale | Standard Deviation 1.14 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -0.48 Scores on a scale | Standard Deviation 0.64 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -0.69 Scores on a scale | Standard Deviation 0.67 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -0.93 Scores on a scale | Standard Deviation 0.79 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -1.12 Scores on a scale | Standard Deviation 0.93 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -1.19 Scores on a scale | Standard Deviation 0.98 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -1.28 Scores on a scale | Standard Deviation 1 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -1.31 Scores on a scale | Standard Deviation 1.09 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -1.37 Scores on a scale | Standard Deviation 1.08 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -1.36 Scores on a scale | Standard Deviation 1.08 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -1.46 Scores on a scale | Standard Deviation 1.17 |
| Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 4.07 Scores on a scale | Standard Deviation 0.95 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -1.74 Scores on a scale | Standard Deviation 0.97 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 4.03 Scores on a scale | Standard Deviation 0.89 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -1.66 Scores on a scale | Standard Deviation 0.97 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -1.80 Scores on a scale | Standard Deviation 1.02 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -1.09 Scores on a scale | Standard Deviation 0.72 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -1.86 Scores on a scale | Standard Deviation 1.13 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -1.77 Scores on a scale | Standard Deviation 1.03 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -1.26 Scores on a scale | Standard Deviation 0.9 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -1.69 Scores on a scale | Standard Deviation 0.98 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -1.86 Scores on a scale | Standard Deviation 1.14 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -1.48 Scores on a scale | Standard Deviation 0.88 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -1.90 Scores on a scale | Standard Deviation 1.1 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -1.54 Scores on a scale | Standard Deviation 0.86 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -1.65 Scores on a scale | Standard Deviation 0.83 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -1.97 Scores on a scale | Standard Deviation 1.02 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -1.72 Scores on a scale | Standard Deviation 0.88 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -2.01 Scores on a scale | Standard Deviation 1.06 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -1.80 Scores on a scale | Standard Deviation 0.93 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -1.87 Scores on a scale | Standard Deviation 0.98 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -2.02 Scores on a scale | Standard Deviation 1.04 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 4.05 Scores on a scale | Standard Deviation 0.88 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -1.05 Scores on a scale | Standard Deviation 0.7 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -1.95 Scores on a scale | Standard Deviation 1.01 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score (DAS) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -1.26 Scores on a scale | Standard Deviation 0.8 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.4929ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.9693ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.4139ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.8905ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.6877ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.4511ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.2786ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.123ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.5061ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.1354ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.1734ANCOVA
Secondary
Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
DAS based on 28 painful joint counts, 28 swollen joint counts, ESR, and GH. DAS28 score calculated as 0.56 √ (28 painful joint count) + 0.28 √ (28 swollen joint count) + 0.70 (ln ESR mm/hr) + 0.014 GH. Change from baseline = DAS at Week x minus Baseline DAS. Total DAS scores could range from 10 (worse outcome) to 0 (better outcome).
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -1.71 Scores on a scale | Standard Deviation 1.44 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -1.63 Scores on a scale | Standard Deviation 1.34 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -1.42 Scores on a scale | Standard Deviation 1.24 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -0.77 Scores on a scale | Standard Deviation 0.83 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -1.54 Scores on a scale | Standard Deviation 1.34 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -1.54 Scores on a scale | Standard Deviation 1.28 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -0.52 Scores on a scale | Standard Deviation 0.75 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -1.75 Scores on a scale | Standard Deviation 1.48 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -1.08 Scores on a scale | Standard Deviation 0.99 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 5.84 Scores on a scale | Standard Deviation 1.13 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -1.61 Scores on a scale | Standard Deviation 1.36 |
| Methotrexate | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -1.33 Scores on a scale | Standard Deviation 1.16 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -2.13 Scores on a scale | Standard Deviation 1.24 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -1.32 Scores on a scale | Standard Deviation 0.86 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -1.51 Scores on a scale | Standard Deviation 1.05 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -1.79 Scores on a scale | Standard Deviation 1.05 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -2.00 Scores on a scale | Standard Deviation 1.15 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -2.08 Scores on a scale | Standard Deviation 1.22 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 5.75 Scores on a scale | Standard Deviation 1.17 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -2.20 Scores on a scale | Standard Deviation 1.31 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -2.22 Scores on a scale | Standard Deviation 1.29 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -2.31 Scores on a scale | Standard Deviation 1.44 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -2.28 Scores on a scale | Standard Deviation 1.51 |
| Etanercept 10 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -2.25 Scores on a scale | Standard Deviation 1.55 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -1.38 Scores on a scale | Standard Deviation 0.88 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -2.45 Scores on a scale | Standard Deviation 1.31 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -1.96 Scores on a scale | Standard Deviation 1.11 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 5.82 Scores on a scale | Standard Deviation 1.02 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -2.45 Scores on a scale | Standard Deviation 1.33 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -1.60 Scores on a scale | Standard Deviation 1.02 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -2.50 Scores on a scale | Standard Deviation 1.38 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -2.31 Scores on a scale | Standard Deviation 1.21 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -2.20 Scores on a scale | Standard Deviation 1.17 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -2.51 Scores on a scale | Standard Deviation 1.37 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -2.36 Scores on a scale | Standard Deviation 1.27 |
| Etanercept 25 mg | Change From Baseline in Disease Activity Score in 28 Joints (DAS28) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -2.09 Scores on a scale | Standard Deviation 1.13 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.6417ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.4698ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.1214ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.4654ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.4006ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.1636ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.2635ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.0965ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.4437ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.1663ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.1049ANCOVA
Secondary
Change From Baseline in Erosion Score at Weeks 24 and 52
Joint erosion score: erosion severity in 44 joints (16 per hand, 6 per foot). Each joint scored according to surface area involved, from 0 (no erosion) to 5 (extensive bone loss from more than one half of articulating bone). Because each side of foot joint was graded, maximum erosion score for foot joint was 10. Thus, maximum erosion score was 280. Change = score at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline, Week 24, and Week 52
Population: rITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Erosion Score at Weeks 24 and 52 | Change at Week 24 | 2.90 Scores on a scale | Standard Error 0.33 |
| Methotrexate | Change From Baseline in Erosion Score at Weeks 24 and 52 | Change at Week 52 | 5.43 Scores on a scale | Standard Error 0.64 |
| Etanercept 10 mg | Change From Baseline in Erosion Score at Weeks 24 and 52 | Change at Week 24 | 1.25 Scores on a scale | Standard Error 0.29 |
| Etanercept 10 mg | Change From Baseline in Erosion Score at Weeks 24 and 52 | Change at Week 52 | 2.75 Scores on a scale | Standard Error 0.57 |
| Etanercept 25 mg | Change From Baseline in Erosion Score at Weeks 24 and 52 | Change at Week 24 | 1.12 Scores on a scale | Standard Error 0.3 |
| Etanercept 25 mg | Change From Baseline in Erosion Score at Weeks 24 and 52 | Change at Week 52 | 2.03 Scores on a scale | Standard Error 0.48 |
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.726ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.5717ANCOVA
Secondary
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
ESR: laboratory test that provided a non-specific measure of inflammation. The test assessed the rate at which red blood cells fell in a test tube and was measured in mm/hour. Normal range: 0-30mm/h. Higher rate consistent with inflammation.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 42.55 mm/hr | Standard Deviation 28.24 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -1.86 mm/hr | Standard Deviation 10.65 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -2.92 mm/hr | Standard Deviation 11.78 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -5.50 mm/hr | Standard Deviation 16.89 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -8.89 mm/hr | Standard Deviation 17.38 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -8.56 mm/hr | Standard Deviation 18.73 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -10.56 mm/hr | Standard Deviation 20.45 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -9.88 mm/hr | Standard Deviation 20.15 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -9.92 mm/hr | Standard Deviation 20.51 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -9.33 mm/hr | Standard Deviation 20.5 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -10.70 mm/hr | Standard Deviation 20.93 |
| Methotrexate | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -10.22 mm/hr | Standard Deviation 21.69 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -14.79 mm/hr | Standard Deviation 23.06 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 42.00 mm/hr | Standard Deviation 29.44 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -15.68 mm/hr | Standard Deviation 19.15 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -16.06 mm/hr | Standard Deviation 21.14 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -13.67 mm/hr | Standard Deviation 13.07 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -15.45 mm/hr | Standard Deviation 18.54 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -15.61 mm/hr | Standard Deviation 23.07 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -13.26 mm/hr | Standard Deviation 14.94 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -16.52 mm/hr | Standard Deviation 20.09 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -15.18 mm/hr | Standard Deviation 17.63 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -13.99 mm/hr | Standard Deviation 17.39 |
| Etanercept 10 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -15.93 mm/hr | Standard Deviation 21.47 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -18.01 mm/hr | Standard Deviation 17.83 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -18.98 mm/hr | Standard Deviation 19.04 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -18.28 mm/hr | Standard Deviation 21.81 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -19.78 mm/hr | Standard Deviation 20.32 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -19.40 mm/hr | Standard Deviation 20.18 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -20.01 mm/hr | Standard Deviation 20.86 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -19.25 mm/hr | Standard Deviation 21.77 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 43.66 mm/hr | Standard Deviation 27.64 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -16.91 mm/hr | Standard Deviation 15.01 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -20.16 mm/hr | Standard Deviation 21.54 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -16.62 mm/hr | Standard Deviation 16.03 |
| Etanercept 25 mg | Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -18.85 mm/hr | Standard Deviation 21.67 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.0274ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.0344ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.0293ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.0452ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.0313ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.0019ANCOVA
Comparison: Week 20p-value: 0.0781ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.0001ANCOVA
Comparison: Week 24p-value: 0.1279ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.0004ANCOVA
Comparison: Week 32p-value: 0.0807ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.0002ANCOVA
Comparison: Week 40p-value: 0.418ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.0061ANCOVA
Comparison: Week 48p-value: 0.1615ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.013ANCOVA
Comparison: Week 52p-value: 0.0948ANCOVA
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
HAQ-DI: participant-reported assessment of ability to perform tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) hygiene; and 8) common activities over past week. Each item scored on 4-point Likert scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Change = scores at observation minus score at Baseline and total possible scores ranged from -3 to 3. An increase in score from baseline represented disease progression and/or joint worsening and a decrease represented improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 1.01 Scores on a scale | Standard Deviation 0.65 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -0.06 Scores on a scale | Standard Deviation 0.36 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -0.12 Scores on a scale | Standard Deviation 0.44 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -0.21 Scores on a scale | Standard Deviation 0.49 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -0.29 Scores on a scale | Standard Deviation 0.54 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -0.30 Scores on a scale | Standard Deviation 0.55 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -0.32 Scores on a scale | Standard Deviation 0.58 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -0.33 Scores on a scale | Standard Deviation 0.62 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -0.33 Scores on a scale | Standard Deviation 0.64 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -0.35 Scores on a scale | Standard Deviation 0.64 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -0.34 Scores on a scale | Standard Deviation 0.65 |
| Methotrexate | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -0.35 Scores on a scale | Standard Deviation 0.64 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -0.56 Scores on a scale | Standard Deviation 0.56 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 1.17 Scores on a scale | Standard Deviation 0.66 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -0.49 Scores on a scale | Standard Deviation 0.53 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -0.56 Scores on a scale | Standard Deviation 0.52 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -0.30 Scores on a scale | Standard Deviation 0.34 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -0.52 Scores on a scale | Standard Deviation 0.51 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -0.57 Scores on a scale | Standard Deviation 0.57 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -0.33 Scores on a scale | Standard Deviation 0.39 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -0.54 Scores on a scale | Standard Deviation 0.52 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -0.51 Scores on a scale | Standard Deviation 0.48 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -0.46 Scores on a scale | Standard Deviation 0.45 |
| Etanercept 10 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -0.56 Scores on a scale | Standard Deviation 0.55 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -0.48 Scores on a scale | Standard Deviation 0.46 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -0.52 Scores on a scale | Standard Deviation 0.49 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -0.60 Scores on a scale | Standard Deviation 0.6 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -0.54 Scores on a scale | Standard Deviation 0.52 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -0.57 Scores on a scale | Standard Deviation 0.54 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -0.59 Scores on a scale | Standard Deviation 0.55 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -0.59 Scores on a scale | Standard Deviation 0.57 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 1.06 Scores on a scale | Standard Deviation 0.67 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -0.34 Scores on a scale | Standard Deviation 0.41 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -0.59 Scores on a scale | Standard Deviation 0.59 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -0.40 Scores on a scale | Standard Deviation 0.43 |
| Etanercept 25 mg | Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -0.58 Scores on a scale | Standard Deviation 0.59 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.1053ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.0144ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.1851ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.0001ANCOVA
Comparison: Week 12p-value: 0.2883ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.0007ANCOVA
Comparison: Week 16p-value: 0.2221ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.0147ANCOVA
Comparison: Week 20p-value: 0.0201ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.0036ANCOVA
Comparison: Week 24p-value: 0.0789ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.0008ANCOVA
Comparison: Week 32p-value: 0.1903ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.0048ANCOVA
Comparison: Week 40p-value: 0.1059ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.0018ANCOVA
Comparison: Week 48p-value: 0.2589ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.004ANCOVA
Comparison: Week 52p-value: 0.2326ANCOVA
Secondary
Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52
JSN score: severity of JSN in 42 joints (15 per hand and 6 per foot), including subluxation, scored from 0 (no/normal JSN) to 4 (complete loss of joint space, bony ankylosis, or luxation). Maximum JSN score was 168. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline, Week 24, and Week 52
Population: rITT
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 | Change at Week 24 | 2.21 Scores on a scale | Standard Error 0.34 |
| Methotrexate | Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 | Change at Week 52 | 4.39 Scores on a scale | Standard Error 0.66 |
| Etanercept 10 mg | Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 | Change at Week 24 | 1.18 Scores on a scale | Standard Error 0.23 |
| Etanercept 10 mg | Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 | Change at Week 52 | 2.44 Scores on a scale | Standard Error 0.42 |
| Etanercept 25 mg | Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 | Change at Week 24 | 0.62 Scores on a scale | Standard Error 0.2 |
| Etanercept 25 mg | Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52 | Change at Week 52 | 1.31 Scores on a scale | Standard Error 0.33 |
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.0013ANCOVA
Comparison: Week 24p-value: 0.0186ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.0006ANCOVA
Comparison: Week 52p-value: 0.1123ANCOVA
Secondary
Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Morning stiffness in and around the joints lasting at least 1 hour before maximal improvement. Change = scores at observation minus score at Baseline. An increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 204.74 Minutes | Standard Deviation 338.7 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -46.39 Minutes | Standard Deviation 250.13 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -34.43 Minutes | Standard Deviation 249.33 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -52.53 Minutes | Standard Deviation 247.74 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -73.48 Minutes | Standard Deviation 236.69 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -78.60 Minutes | Standard Deviation 252.64 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -87.11 Minutes | Standard Deviation 276.35 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -89.94 Minutes | Standard Deviation 295.48 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -95.32 Minutes | Standard Deviation 330.07 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -97.76 Minutes | Standard Deviation 332.93 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -99.38 Minutes | Standard Deviation 306.33 |
| Methotrexate | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -98.98 Minutes | Standard Deviation 303.71 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -124.86 Minutes | Standard Deviation 361.03 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 203.80 Minutes | Standard Deviation 304.92 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -137.18 Minutes | Standard Deviation 320.34 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -137.26 Minutes | Standard Deviation 332.5 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -98.73 Minutes | Standard Deviation 259.91 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -136.18 Minutes | Standard Deviation 318.85 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -136.23 Minutes | Standard Deviation 333.45 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -94.87 Minutes | Standard Deviation 280.56 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -137.72 Minutes | Standard Deviation 317.24 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -128.02 Minutes | Standard Deviation 309.89 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -122.13 Minutes | Standard Deviation 304.33 |
| Etanercept 10 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -142.06 Minutes | Standard Deviation 335.44 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -127.55 Minutes | Standard Deviation 279.88 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -129.74 Minutes | Standard Deviation 284.58 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -157.52 Minutes | Standard Deviation 336.53 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -148.13 Minutes | Standard Deviation 304.03 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -153.01 Minutes | Standard Deviation 314.41 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -143.03 Minutes | Standard Deviation 332.16 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -163.03 Minutes | Standard Deviation 326.06 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 223.48 Minutes | Standard Deviation 344.75 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -108.37 Minutes | Standard Deviation 256.49 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -163.64 Minutes | Standard Deviation 320.36 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -107.09 Minutes | Standard Deviation 255.06 |
| Etanercept 25 mg | Change From Baseline in Mean Duration of Morning Stiffness at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -171.36 Minutes | Standard Deviation 322.43 |
Comparison: Week 2p-value: 0.0027ANCOVA
Comparison: Week 2p-value: 0.0015ANCOVA
Comparison: Week 2p-value: 0.8875ANCOVA
Comparison: Week 4p-value: 0.0015ANCOVA
Comparison: Week 4p-value: 0.0011ANCOVA
Comparison: Week 4p-value: 0.9694ANCOVA
Comparison: Week 8p-value: 0.002ANCOVA
Comparison: Week 8p-value: 0.0005ANCOVA
Comparison: Week 8p-value: 0.7271ANCOVA
Comparison: Week 12p-value: 0.0235ANCOVA
Comparison: Week 12p-value: 0.0061ANCOVA
Comparison: Week 12p-value: 0.6427ANCOVA
Comparison: Week 16p-value: 0.0036ANCOVA
Comparison: Week 16p-value: 0.0029ANCOVA
Comparison: Week 16p-value: 0.9713ANCOVA
Comparison: Week 20p-value: 0.006ANCOVA
Comparison: Week 20p-value: 0.006ANCOVA
Comparison: Week 20p-value: 0.9762ANCOVA
Comparison: Week 24p-value: 0.0554ANCOVA
Comparison: Week 24p-value: 0.0181ANCOVA
Comparison: Week 24p-value: 0.6642ANCOVA
Comparison: Week 32p-value: 0.0073ANCOVA
Comparison: Week 32p-value: 0.029ANCOVA
Comparison: Week 32p-value: 0.5919ANCOVA
Comparison: Week 40p-value: 0.0371ANCOVA
Comparison: Week 40p-value: 0.0346ANCOVA
Comparison: Week 40p-value: 0.9955ANCOVA
Comparison: Week 48p-value: 0.0187ANCOVA
Comparison: Week 48p-value: 0.0645ANCOVA
Comparison: Week 48p-value: 0.592ANCOVA
Comparison: Week 52p-value: 0.0095ANCOVA
Comparison: Week 52p-value: 0.2112ANCOVA
Comparison: Week 52p-value: 0.1649ANCOVA
Secondary
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.
Time frame: Week 24
Population: rITT
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Methotrexate | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | 5.11 Scores on a scale | Standard Error 0.58 |
| Etanercept 10 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | 2.42 Scores on a scale | Standard Error 0.48 |
| Etanercept 25 mg | Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24 | 1.74 Scores on a scale | Standard Error 0.45 |
p-value: <0.0001ANCOVA
p-value: <0.0001ANCOVA
p-value: 0.2248ANCOVA
Secondary
Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
71 joints assessed by the investigator using criteria based on pressure and joint manipulation. Change = scores at observation minus score at Baseline, and total possible scores ranged from -71 to 71. An increase in tender joint count from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 17.12 Tender Joints | Standard Deviation 10.78 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -3.41 Tender Joints | Standard Deviation 7.48 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -5.58 Tender Joints | Standard Deviation 8.34 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -6.83 Tender Joints | Standard Deviation 8.3 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -8.42 Tender Joints | Standard Deviation 9.08 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -8.82 Tender Joints | Standard Deviation 9.44 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -9.15 Tender Joints | Standard Deviation 9.93 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -9.47 Tender Joints | Standard Deviation 10.3 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -9.91 Tender Joints | Standard Deviation 10.56 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -9.97 Tender Joints | Standard Deviation 10.43 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -10.45 Tender Joints | Standard Deviation 10.69 |
| Methotrexate | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -10.27 Tender Joints | Standard Deviation 10.6 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -10.75 Tender Joints | Standard Deviation 9.99 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 16.30 Tender Joints | Standard Deviation 10.56 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -10.86 Tender Joints | Standard Deviation 9.85 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -10.93 Tender Joints | Standard Deviation 9.75 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -6.81 Tender Joints | Standard Deviation 7.67 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -10.70 Tender Joints | Standard Deviation 9.79 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -10.78 Tender Joints | Standard Deviation 9.84 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -7.74 Tender Joints | Standard Deviation 9.21 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -10.94 Tender Joints | Standard Deviation 9.64 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -9.94 Tender Joints | Standard Deviation 9.63 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -9.27 Tender Joints | Standard Deviation 9.5 |
| Etanercept 10 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -11.07 Tender Joints | Standard Deviation 10.32 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -10.86 Tender Joints | Standard Deviation 9.07 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -11.36 Tender Joints | Standard Deviation 9.2 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -12.73 Tender Joints | Standard Deviation 10.87 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -11.81 Tender Joints | Standard Deviation 9.29 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -12.38 Tender Joints | Standard Deviation 10.1 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -12.48 Tender Joints | Standard Deviation 9.81 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -13.17 Tender Joints | Standard Deviation 11.2 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 17.48 Tender Joints | Standard Deviation 11.21 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -7.73 Tender Joints | Standard Deviation 7.81 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -12.97 Tender Joints | Standard Deviation 10.14 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -8.65 Tender Joints | Standard Deviation 7.75 |
| Etanercept 25 mg | Change From Baseline in Number of Painful Joints on Pressure or on Motion at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -13.23 Tender Joints | Standard Deviation 11.13 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.4237ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.0002ANCOVA
Comparison: Week 4p-value: 0.5738ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.1606ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.0016ANCOVA
Comparison: Week 12p-value: 0.2412ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.5882ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.0001ANCOVA
Comparison: Week 20p-value: 0.2257ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.0003ANCOVA
Comparison: Week 24p-value: 0.2075ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.005ANCOVA
Comparison: Week 32p-value: 0.0461ANCOVA
Comparison: Week 40p-value: 0.0002ANCOVA
Comparison: Week 40p-value: 0.0101ANCOVA
Comparison: Week 40p-value: 0.2351ANCOVA
Comparison: Week 48p-value: 0.0002ANCOVA
Comparison: Week 48p-value: 0.1179ANCOVA
Comparison: Week 48p-value: 0.0214ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.079ANCOVA
Comparison: Week 52p-value: 0.0168ANCOVA
Secondary
Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Patient's Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -1.11 Scores on a scale | Standard Deviation 1.99 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -1.88 Scores on a scale | Standard Deviation 2.68 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 6.01 Scores on a scale | Standard Deviation 2.28 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -1.97 Scores on a scale | Standard Deviation 2.77 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -1.34 Scores on a scale | Standard Deviation 2.31 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -1.97 Scores on a scale | Standard Deviation 2.7 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -0.65 Scores on a scale | Standard Deviation 1.95 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -1.63 Scores on a scale | Standard Deviation 2.52 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -1.71 Scores on a scale | Standard Deviation 2.45 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -1.85 Scores on a scale | Standard Deviation 2.42 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -1.85 Scores on a scale | Standard Deviation 2.66 |
| Methotrexate | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -1.89 Scores on a scale | Standard Deviation 2.71 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -2.65 Scores on a scale | Standard Deviation 2.45 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -2.84 Scores on a scale | Standard Deviation 2.44 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -1.89 Scores on a scale | Standard Deviation 2.06 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -2.59 Scores on a scale | Standard Deviation 2.36 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -2.89 Scores on a scale | Standard Deviation 2.44 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -2.57 Scores on a scale | Standard Deviation 2.22 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -1.81 Scores on a scale | Standard Deviation 1.86 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -2.95 Scores on a scale | Standard Deviation 2.46 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 6.12 Scores on a scale | Standard Deviation 2.17 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -2.55 Scores on a scale | Standard Deviation 2.37 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -3.04 Scores on a scale | Standard Deviation 2.58 |
| Etanercept 10 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -2.37 Scores on a scale | Standard Deviation 2.05 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -2.91 Scores on a scale | Standard Deviation 2.6 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 5.95 Scores on a scale | Standard Deviation 2.01 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -1.79 Scores on a scale | Standard Deviation 1.82 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -1.91 Scores on a scale | Standard Deviation 2.04 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -2.27 Scores on a scale | Standard Deviation 2.13 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -2.38 Scores on a scale | Standard Deviation 2.29 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -2.69 Scores on a scale | Standard Deviation 2.34 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -2.79 Scores on a scale | Standard Deviation 2.45 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -2.92 Scores on a scale | Standard Deviation 2.58 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -2.82 Scores on a scale | Standard Deviation 2.67 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -2.98 Scores on a scale | Standard Deviation 2.52 |
| Etanercept 25 mg | Change From Baseline in Patient's Global Assessment at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -2.54 Scores on a scale | Standard Deviation 2.4 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.7488ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.568ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.9241ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.7146ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.0001ANCOVA
Comparison: Week 16p-value: 0.6574ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.0004ANCOVA
Comparison: Week 20p-value: 0.2936ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.0005ANCOVA
Comparison: Week 24p-value: 0.2179ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.3704ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.8047ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.5277ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.9371ANCOVA
Secondary
Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Physician Global Assessment of symptoms, assessed using a 11-point rating scale, where 0=asymptomatic and 10=severe symptoms. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 6.34 Scores on a scale | Standard Deviation 1.98 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 2 | -1.23 Scores on a scale | Standard Deviation 1.67 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 4 | -1.66 Scores on a scale | Standard Deviation 1.81 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 8 | -2.13 Scores on a scale | Standard Deviation 2.05 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 12 | -2.43 Scores on a scale | Standard Deviation 2.13 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 16 | -2.51 Scores on a scale | Standard Deviation 2.21 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 20 | -2.54 Scores on a scale | Standard Deviation 2.29 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 24 | -2.60 Scores on a scale | Standard Deviation 2.43 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 32 | -2.70 Scores on a scale | Standard Deviation 2.36 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 40 | -2.63 Scores on a scale | Standard Deviation 2.41 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 48 | -2.70 Scores on a scale | Standard Deviation 2.52 |
| Methotrexate | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 52 | -2.72 Scores on a scale | Standard Deviation 2.4 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 52 | -3.68 Scores on a scale | Standard Deviation 2.42 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 6.23 Scores on a scale | Standard Deviation 1.79 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 20 | -3.51 Scores on a scale | Standard Deviation 2.07 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 32 | -3.54 Scores on a scale | Standard Deviation 2.24 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 2 | -2.20 Scores on a scale | Standard Deviation 1.71 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 16 | -3.46 Scores on a scale | Standard Deviation 2.02 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 48 | -3.59 Scores on a scale | Standard Deviation 2.45 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 4 | -2.65 Scores on a scale | Standard Deviation 1.91 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 24 | -3.52 Scores on a scale | Standard Deviation 2.22 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 12 | -3.30 Scores on a scale | Standard Deviation 2.04 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 8 | -3.02 Scores on a scale | Standard Deviation 1.89 |
| Etanercept 10 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 40 | -3.62 Scores on a scale | Standard Deviation 2.28 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 8 | -3.14 Scores on a scale | Standard Deviation 1.89 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 12 | -3.34 Scores on a scale | Standard Deviation 1.94 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 40 | -3.97 Scores on a scale | Standard Deviation 2.27 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 16 | -3.53 Scores on a scale | Standard Deviation 1.99 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 20 | -3.76 Scores on a scale | Standard Deviation 2.01 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 24 | -3.76 Scores on a scale | Standard Deviation 2.07 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 48 | -4.03 Scores on a scale | Standard Deviation 2.2 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 6.20 Scores on a scale | Standard Deviation 1.86 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 2 | -2.25 Scores on a scale | Standard Deviation 1.71 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 32 | -3.94 Scores on a scale | Standard Deviation 2.09 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 4 | -2.67 Scores on a scale | Standard Deviation 1.9 |
| Etanercept 25 mg | Change From Baseline in Physician's Global Assessment of Symptoms at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Week 52 | -4.07 Scores on a scale | Standard Deviation 2.11 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.6337ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.7407ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.3473ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.7529ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.5216ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.1078ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.128ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.0291ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.0729ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.0271ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.0453ANCOVA
Secondary
Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
American College of Rheumatology (ACR) swollen joint count was an assessment of 68 joints. Joints classified as either swollen or not swollen. Change = scores at observation minus score at Baseline, and total possible scores ranged from -68 to 68. 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.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: Modified ITT (mITT) population: participants who received at least 1 dose of the assigned test article; Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 13.84 Swollen Joints | Standard Deviation 7.81 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -3.39 Swollen Joints | Standard Deviation 6.59 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -4.31 Swollen Joints | Standard Deviation 6.68 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -5.76 Swollen Joints | Standard Deviation 6.41 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -6.36 Swollen Joints | Standard Deviation 6.97 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -6.59 Swollen Joints | Standard Deviation 6.77 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -7.21 Swollen Joints | Standard Deviation 7.47 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -7.06 Swollen Joints | Standard Deviation 7.52 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -7.47 Swollen Joints | Standard Deviation 7.74 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -7.93 Swollen Joints | Standard Deviation 7.83 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -7.53 Swollen Joints | Standard Deviation 8.26 |
| Methotrexate | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -7.53 Swollen Joints | Standard Deviation 8.09 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -9.79 Swollen Joints | Standard Deviation 8.58 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 14.23 Swollen Joints | Standard Deviation 8.97 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -9.68 Swollen Joints | Standard Deviation 7.92 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -9.89 Swollen Joints | Standard Deviation 8.51 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -5.96 Swollen Joints | Standard Deviation 6.94 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -9.29 Swollen Joints | Standard Deviation 7.93 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -9.87 Swollen Joints | Standard Deviation 8.51 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -7.03 Swollen Joints | Standard Deviation 7.57 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -9.58 Swollen Joints | Standard Deviation 7.98 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -9.05 Swollen Joints | Standard Deviation 7.79 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -8.38 Swollen Joints | Standard Deviation 7.77 |
| Etanercept 10 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -9.97 Swollen Joints | Standard Deviation 8.53 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -7.91 Swollen Joints | Standard Deviation 6.71 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -8.55 Swollen Joints | Standard Deviation 6.72 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -10.05 Swollen Joints | Standard Deviation 8.02 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -8.78 Swollen Joints | Standard Deviation 6.89 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -9.43 Swollen Joints | Standard Deviation 7.45 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -9.57 Swollen Joints | Standard Deviation 7.51 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -10.30 Swollen Joints | Standard Deviation 8.41 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 14.00 Swollen Joints | Standard Deviation 8.8 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -5.02 Swollen Joints | Standard Deviation 5.66 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -9.79 Swollen Joints | Standard Deviation 7.62 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -6.95 Swollen Joints | Standard Deviation 6.35 |
| Etanercept 25 mg | Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -10.49 Swollen Joints | Standard Deviation 8.14 |
Comparison: Week 2p-value: 0.0032ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.1224ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.8037ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.5495ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.4948ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.4663ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.9357ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.7439ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.8611ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.6731ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.2616ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.0001ANCOVA
Comparison: Week 52p-value: 0.1158ANCOVA
Secondary
Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
100mm line (VAS) marked by participant. Participants asked, In general how would you rate your health over the last 2-3 weeks? 0mm=very well to 100mm=extremely bad. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 58.37 mm | Standard Deviation 24.04 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -8.06 mm | Standard Deviation 19 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -13.51 mm | Standard Deviation 21.35 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -15.59 mm | Standard Deviation 24.92 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -20.05 mm | Standard Deviation 25.5 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -20.89 mm | Standard Deviation 27.29 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -22.35 mm | Standard Deviation 25.37 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -21.78 mm | Standard Deviation 27.55 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -22.87 mm | Standard Deviation 27.6 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -22.69 mm | Standard Deviation 28.18 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -23.76 mm | Standard Deviation 29.21 |
| Methotrexate | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -23.34 mm | Standard Deviation 28.48 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -32.25 mm | Standard Deviation 27.02 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 58.71 mm | Standard Deviation 23.08 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -29.51 mm | Standard Deviation 25.05 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -31.92 mm | Standard Deviation 24.91 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -21.07 mm | Standard Deviation 20.39 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -28.37 mm | Standard Deviation 26.15 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -32.15 mm | Standard Deviation 26.01 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -20.65 mm | Standard Deviation 23.18 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -30.23 mm | Standard Deviation 25.23 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -28.08 mm | Standard Deviation 24.87 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -26.16 mm | Standard Deviation 23.39 |
| Etanercept 10 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -31.49 mm | Standard Deviation 27.26 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -25.57 mm | Standard Deviation 22.59 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -26.34 mm | Standard Deviation 23.27 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -30.36 mm | Standard Deviation 25.54 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -27.30 mm | Standard Deviation 24.73 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -29.16 mm | Standard Deviation 24.79 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -29.52 mm | Standard Deviation 25.39 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -31.27 mm | Standard Deviation 25.42 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 55.70 mm | Standard Deviation 21.68 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -20.27 mm | Standard Deviation 22.08 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -31.11 mm | Standard Deviation 25.86 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -20.69 mm | Standard Deviation 22.47 |
| Etanercept 25 mg | Change From Baseline in VAS for Participant General Health at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -31.08 mm | Standard Deviation 26.6 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.8044ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.0003ANCOVA
Comparison: Week 4p-value: 0.4652ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.5612ANCOVA
Comparison: Week 12p-value: 0.0002ANCOVA
Comparison: Week 12p-value: 0.0002ANCOVA
Comparison: Week 12p-value: 0.9749ANCOVA
Comparison: Week 16p-value: 0.0001ANCOVA
Comparison: Week 16p-value: 0.0004ANCOVA
Comparison: Week 16p-value: 0.729ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.0003ANCOVA
Comparison: Week 20p-value: 0.5004ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.5727ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.6713ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.0001ANCOVA
Comparison: Week 40p-value: 0.7663ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.0002ANCOVA
Comparison: Week 48p-value: 0.7073ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.0001ANCOVA
Comparison: Week 52p-value: 0.7973ANCOVA
Secondary
Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
100 millimeter (mm) line (VAS) marked by participant. Intensity of pain range (over past week): 0mm = no pain to 100mm = worst possible pain. Change = scores at observation minus score at Baseline. An increase in score from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 54.91 mm | Standard Deviation 23.62 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -5.98 mm | Standard Deviation 19.11 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -10.64 mm | Standard Deviation 21.45 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -13.48 mm | Standard Deviation 25.21 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -16.95 mm | Standard Deviation 25.09 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -17.97 mm | Standard Deviation 26.61 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -19.53 mm | Standard Deviation 24.67 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -19.53 mm | Standard Deviation 27.02 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -19.72 mm | Standard Deviation 27.01 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -19.68 mm | Standard Deviation 27.35 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -20.85 mm | Standard Deviation 28.08 |
| Methotrexate | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -20.03 mm | Standard Deviation 27.74 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -29.08 mm | Standard Deviation 25.85 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 54.37 mm | Standard Deviation 23.1 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -25.39 mm | Standard Deviation 24.01 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -28.68 mm | Standard Deviation 25 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -18.85 mm | Standard Deviation 19.76 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -24.41 mm | Standard Deviation 24.53 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -28.28 mm | Standard Deviation 25.04 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -18.18 mm | Standard Deviation 22.95 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -26.86 mm | Standard Deviation 24.37 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -24.70 mm | Standard Deviation 22.74 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -23.09 mm | Standard Deviation 22.37 |
| Etanercept 10 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -28.81 mm | Standard Deviation 26.09 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 8 | -22.46 mm | Standard Deviation 22.34 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 12 | -24.01 mm | Standard Deviation 22.7 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 40 | -27.17 mm | Standard Deviation 25.26 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 16 | -25.63 mm | Standard Deviation 25.04 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 20 | -26.52 mm | Standard Deviation 24.58 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 24 | -26.73 mm | Standard Deviation 24.99 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 48 | -28.77 mm | Standard Deviation 25.5 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Baseline | 52.63 mm | Standard Deviation 21.54 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 2 | -18.67 mm | Standard Deviation 20.32 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 32 | -28.10 mm | Standard Deviation 25.85 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 4 | -19.16 mm | Standard Deviation 21.86 |
| Etanercept 25 mg | Change From Baseline in Visual Analogue Scale for Pain (VAS-pain) at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52 | Change at Week 52 | -28.34 mm | Standard Deviation 25.92 |
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: <0.0001ANCOVA
Comparison: Week 2p-value: 0.8972ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: <0.0001ANCOVA
Comparison: Week 4p-value: 0.3736ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: <0.0001ANCOVA
Comparison: Week 8p-value: 0.9324ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: <0.0001ANCOVA
Comparison: Week 12p-value: 0.8982ANCOVA
Comparison: Week 16p-value: <0.0001ANCOVA
Comparison: Week 16p-value: 0.0007ANCOVA
Comparison: Week 16p-value: 0.318ANCOVA
Comparison: Week 20p-value: <0.0001ANCOVA
Comparison: Week 20p-value: 0.0011ANCOVA
Comparison: Week 20p-value: 0.3302ANCOVA
Comparison: Week 24p-value: <0.0001ANCOVA
Comparison: Week 24p-value: 0.0002ANCOVA
Comparison: Week 24p-value: 0.6563ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: <0.0001ANCOVA
Comparison: Week 32p-value: 0.8894ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: <0.0001ANCOVA
Comparison: Week 40p-value: 0.7826ANCOVA
Comparison: Week 48p-value: <0.0001ANCOVA
Comparison: Week 48p-value: 0.0003ANCOVA
Comparison: Week 48p-value: 0.5343ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: <0.0001ANCOVA
Comparison: Week 52p-value: 0.9313ANCOVA
Secondary
Percentage of Participants With an ACR50 Response
ACR50 response: ≥ 50% improvement in tender joint count; ≥ 50% improvement in swollen joint count; and ≥ 50% 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 CRP.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 24 | 32.4 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 2 | 2.3 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 4 | 4.0 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 8 | 15.3 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 12 | 23.9 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 16 | 26.1 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 20 | 30.7 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 32 | 34.7 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 40 | 36.9 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 48 | 39.2 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR50 Response | Week 52 | 36.9 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 12 | 47.4 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 52 | 59.4 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 16 | 50.0 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 48 | 57.3 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 20 | 50.0 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 24 | 53.6 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 32 | 60.4 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 2 | 14.7 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 4 | 28.1 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 40 | 60.4 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR50 Response | Week 8 | 38.5 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 4 | 22.5 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 12 | 42.3 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 32 | 59.3 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 8 | 35.7 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 16 | 44.0 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 2 | 16.0 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 52 | 62.1 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 20 | 50.5 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 40 | 58.8 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 24 | 54.4 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR50 Response | Week 48 | 57.7 Percentage of participants |
Comparison: Week 2p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.0001Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.4376Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.3947Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.7378Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.0001Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.568Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.0003Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.3978Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.0001Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.7229Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.7236Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.9719Cochran-Mantel-Haenszel
Comparison: Week 40p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 40p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.9349Cochran-Mantel-Haenszel
Comparison: Week 48p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.0002Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.7226Cochran-Mantel-Haenszel
Comparison: Week 52p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 52p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.5512Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an ACR70 Response
ACR70 response: ≥ 70% improvement in tender joint count; ≥ 70% improvement in swollen joint count; and ≥ 70% 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 CRP.
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 2 | 0 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 4 | 0.6 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 8 | 2.8 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 12 | 9.7 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 16 | 9.7 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 20 | 13.1 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 24 | 11.9 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 32 | 11.9 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 40 | 14.8 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 52 | 15.9 Percentage of participants |
| Methotrexate | Percentage of Participants With an ACR70 Response | Week 48 | 18.2 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 12 | 21.9 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 16 | 17.7 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 48 | 34.4 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 20 | 25.0 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 24 | 25.5 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 32 | 28.1 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 2 | 4.2 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 4 | 7.8 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 52 | 33.9 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 8 | 15.1 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an ACR70 Response | Week 40 | 31.3 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 4 | 8.2 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 40 | 35.7 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 8 | 11.0 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 16 | 18.7 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 2 | 3.8 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 32 | 31.3 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 20 | 25.3 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 48 | 36.3 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 12 | 15.4 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 24 | 25.8 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an ACR70 Response | Week 52 | 36.3 Percentage of participants |
Comparison: Week 2p-value: 0.0162Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.0035Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.8928Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.0009Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.0007Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.6348Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.0026Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.4629Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.0841Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.0007Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.1957Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.0093Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.0326Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.7426Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.0013Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.0015Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.6552Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.0005Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.0004Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.6294Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.0001Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.4652Cochran-Mantel-Haenszel
Comparison: Week 40p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.0002Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.2233Cochran-Mantel-Haenszel
Comparison: Week 48p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.0003Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.6772Cochran-Mantel-Haenszel
Comparison: Week 52p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 52p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.616Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response
ACR20 response: greater than or equal to (≥) 20 percent (%) improvement in tender joint count; ≥ 20% improvement in swollen joint count; and ≥ 20% 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 Health Assessment Questionnaire \[HAQ\]); and C-Reactive Protein (CRP).
Time frame: Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52
Population: mITT; LOCF
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 32 | 58.0 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 16 | 51.7 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 59.1 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 56.3 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 20 | 58.5 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 2 | 16.1 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 8 | 43.2 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 4 | 27.3 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 40 | 59.7 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 12 | 48.3 Percentage of participants |
| Methotrexate | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 52 | 62.5 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 20 | 75.4 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 2 | 54.0 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 4 | 55.5 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 8 | 68.1 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 12 | 70.2 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 16 | 73.8 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 77.0 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 32 | 79.1 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 40 | 78.5 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 76.4 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 52 | 75.9 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 48 | 79.7 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 32 | 80.8 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 8 | 68.7 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 2 | 49.4 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 40 | 75.3 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 4 | 56.9 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 20 | 78.6 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 16 | 75.3 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 52 | 78.6 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 24 | 77.5 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response | Week 12 | 77.5 Percentage of participants |
Comparison: Week 2p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 2p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 2p-value: 0.4751Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 4p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 4p-value: 0.4653Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 8p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.7953Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 12p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.0848Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 16p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.6112Cochran-Mantel-Haenszel
Comparison: Week 20p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.0002Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.3671Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 24p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.7618Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 32p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.4358Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.0008Cochran-Mantel-Haenszel
Comparison: Week 40p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.6267Cochran-Mantel-Haenszel
Comparison: Week 48p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.0004Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.3564Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.0007Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.0035Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.4749Cochran-Mantel-Haenszel
Secondary
Percentage of Participants With no Progression of Joint Destruction at Week 52
Absence of joint destruction defined by 3 categories (mTSS change \<=0.5, \<=3.0, and \<smallest detectable difference \[SDD\] where SDDs were scores \>3.0). mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score).
Time frame: Baseline and Week 52
Population: rITT
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Methotrexate | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤3.0 | 46.8 Percentage of participants |
| Methotrexate | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤0.5 | 25.7 Percentage of participants |
| Methotrexate | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤SDD | 81.9 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤3.0 | 64.2 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤0.5 | 45.3 Percentage of participants |
| Etanercept 10 mg | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤SDD | 88.9 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤0.5 | 49.2 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤SDD | 94.5 Percentage of participants |
| Etanercept 25 mg | Percentage of Participants With no Progression of Joint Destruction at Week 52 | Progression ≤3.0 | 68.0 Percentage of participants |
Comparison: Week 52 for progression \<=0.5p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: Week 52 for progression \<=0.5p-value: 0.0002Cochran-Mantel-Haenszel
Comparison: Week 52 for progression \<=0.5p-value: 0.3022Cochran-Mantel-Haenszel
Comparison: Week 52 for progression \<=3.0p-value: 0.0001Cochran-Mantel-Haenszel
Comparison: Week 52 for progression \<=3.0p-value: 0.0002Cochran-Mantel-Haenszel
Comparison: Week 52 for progression \<=3.0p-value: 0.312Cochran-Mantel-Haenszel
Comparison: Week 52 for progression \<=SDDp-value: 0.001Cochran-Mantel-Haenszel
Comparison: Week 52 for progression \<=SDDp-value: 0.0285Cochran-Mantel-Haenszel
Comparison: Week 52 for progression \<=SDDp-value: 0.0433Cochran-Mantel-Haenszel
Other Pre-specified
Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses
Time frame: Weeks 12, 24, 52
Population: mITT; n = evaluable participants at the specified time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Methotrexate | Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses | Week 12 (n=179, 164) | 1012 nanograms per milliliter (ng/mL) | Standard Error 30.3 |
| Methotrexate | Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses | Week 24 (n=171, 171) | 1094 nanograms per milliliter (ng/mL) | Standard Error 32.2 |
| Methotrexate | Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses | Week 52 (n=158, 149) | 1097 nanograms per milliliter (ng/mL) | Standard Error 34.4 |
| Etanercept 10 mg | Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses | Week 12 (n=179, 164) | 2490 nanograms per milliliter (ng/mL) | Standard Error 79.6 |
| Etanercept 10 mg | Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses | Week 24 (n=171, 171) | 2500 nanograms per milliliter (ng/mL) | Standard Error 79.3 |
| Etanercept 10 mg | Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses | Week 52 (n=158, 149) | 2754 nanograms per milliliter (ng/mL) | Standard Error 136 |