Rheumatoid Arthritis
Conditions
Keywords
enbrel, moderate arthritis, severe arthritis, rheumatoid arthritis
Brief summary
The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.
Interventions
BIOLOGICALPhase 1: Etanercept
Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24
DRUGPhase 1: Methotrexate
Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.
DRUGPhase 2: Optional ETN, SSZ, HCQ, MTX
Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128. Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.
DRUGPhase 1: Conventiaonal DMARD
Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.
Sponsors
Amgen
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Rheumatoid Arthritis (RA) * Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA) * Active Rheumatoid Arthritis (RA) at time of screening and baseline
Exclusion criteria
* Previous or current treatment with etanercept, other tumor necrosis factor-alpha inhibitors, or other biologic agents * Concurrent treatment with a Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, at screening * Receipt of any Disease Modifying Antirheumatic Drug (DMARD), other than methotrexate, within 3 months before screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 | Week 24 | ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 | Baseline and Week 24 | mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS 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 Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant's general health using a 100 mm-visual analog scale (VAS). DAS28\<3.2 indicates low disease activity and DAS28\<2.6 remission. |
| Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant's general health using a 100 mm-VAS. DAS28\<3.2 indicates low disease activity and DAS28\<2.6 remission. |
| Summary of Changes in Therapy at the Beginning of Phase 2 | Week 24 | The investigators were allowed to alter each participant's therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized. |
| Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR. |
| Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR. |
| Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP. |
| Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR. |
| Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS\<1.6 remission. |
| Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS\<1.6 remission. |
| Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24 | Week 24 | DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission. |
| Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24 | Week 24 | DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission. |
| Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission. |
| Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission. |
| Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission. |
| Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission. |
| Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as: * DAS-value ≤3.7 and DAS-improvement from Baseline \>0.6 * DAS-value \>3.7 and DAS-improvement from Baseline \>1.2 |
| Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as: * DAS-value ≤3.7 and DAS-improvement from Baseline \>0.6 * DAS-value \>3.7 and DAS-improvement from Baseline \>1.2 |
| Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline \>1.2. |
| Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline \>1.2. |
| Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as: * DAS28-value ≤5.1 and DAS28-improvement from Baseline \>0.6 * DAS28-value \>5.1 and DAS28-improvement from Baseline \>1.2 |
| Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as: * DAS28-value ≤5.1 and DAS28-improvement from Baseline \>0.6 * DAS28-value \>5.1 and DAS28-improvement from Baseline \>1.2 |
| Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline \>1.2. |
| Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline \>1.2. |
| Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission. |
| Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission. |
| Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission. |
| Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission. |
| Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission. |
| Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission. |
| Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission. |
| Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission. |
| Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome. |
| Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome. |
| Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome. |
| Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome. |
| Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician. |
| Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician. |
| Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity). |
| Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity). |
| Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet. |
| Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet. |
| Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks. |
| Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks. |
| Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days. |
| Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days. |
| Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week. |
| Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week. |
| Change From Baseline in Joint Space Narrowing Score Using vdH 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). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS 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 Erosion Score Using vdH 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). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS 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 Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory. |
| Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory. |
| Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory. |
| Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 50, Week 76, Week 102, and Week 128 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 50, Week 76, Week 102, and Week 128 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in HAQ Score at Week 24 | Baseline and Week 24 | HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation. |
| Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 8, Week 16, and Week 24 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
| Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 50, Week 76, Week 102, and Week 128 | The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status. |
Countries
Argentina, Chile, Colombia, Mexico, Panama
Participant flow
Recruitment details
The study consisted of 3 periods - Phase 1 (week 0-week 24), Phase 2 Year 1 (week 24-week 76), and Phase 2 Year 2 (week 76-week 128). 429 participants were randomly assigned to open label etanercept + methotrexate or open label conventional disease-modifying antirheumatic drug (DMARD) + methotrexate in a 2:1 allocation, respectively.
Pre-assignment details
Five participants (etanercept + methotrexate: 3, DMARD + methotrexate: 2) were randomized but did not receive study treatment. These participants were either randomized in error or withdrew consent before receiving the first dose. Phase 1 DMARD therapy was either hydroxychloroquine (HCQ) or sulfsalazine (SSZ), as selected by the investigator.
Participants by arm
| Arm | Count |
|---|---|
| Etanercept + Methotrexate Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen. | 281 |
| DMARD + Methotrexate Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant's Phase 2 treament regimen. | 143 |
| Total | 424 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Phase 1 | Adverse Event | 5 | 4 |
| Phase 1 | Discontinuation of study by sponsor | 2 | 1 |
| Phase 1 | Failed to return | 0 | 1 |
| Phase 1 | Lack of Efficacy | 0 | 1 |
| Phase 1 | Lost to Follow-up | 1 | 1 |
| Phase 1 | Protocol Violation | 1 | 1 |
| Phase 1 | Unspecified Reason | 1 | 1 |
| Phase 1 | Withdrawal by Subject | 2 | 4 |
| Phase 2 Year 1 | Adverse Event | 7 | 2 |
| Phase 2 Year 1 | Death | 1 | 0 |
| Phase 2 Year 1 | Failed to Return | 1 | 1 |
| Phase 2 Year 1 | Lost to Follow-up | 1 | 0 |
| Phase 2 Year 1 | Protocol Violation | 4 | 1 |
| Phase 2 Year 1 | Subject Request | 1 | 2 |
| Phase 2 Year 1 | Unspecified Reason | 3 | 0 |
| Phase 2 Year 2 | Adverse Event | 12 | 2 |
| Phase 2 Year 2 | Death | 2 | 0 |
| Phase 2 Year 2 | Failed to return | 3 | 0 |
| Phase 2 Year 2 | Lost to Follow-up | 1 | 3 |
| Phase 2 Year 2 | Protocol Violation | 1 | 1 |
| Phase 2 Year 2 | Subject Request | 1 | 1 |
| Phase 2 Year 2 | Unsatisfactory Response - Efficacy | 2 | 0 |
| Phase 2 Year 2 | Unspecified Reason | 1 | 0 |
Baseline characteristics
| Characteristic | Etanercept + Methotrexate | DMARD + Methotrexate | Total |
|---|---|---|---|
| Age, Continuous | 48.4 years STANDARD_DEVIATION 11.99 | 48.7 years STANDARD_DEVIATION 11.4 | 48.5 years STANDARD_DEVIATION 11.78 |
| Sex: Female, Male Female | 248 Participants | 129 Participants | 377 Participants |
| Sex: Female, Male Male | 33 Participants | 14 Participants | 47 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 64 / 281 | 41 / 143 | 19 / 260 | 19 / 126 | 37 / 241 | 20 / 120 |
| serious Total, serious adverse events | 10 / 281 | 2 / 143 | 17 / 260 | 4 / 126 | 11 / 241 | 2 / 120 |
Outcome results
Primary
Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).
Time frame: Week 24
Population: Modified intent-to-treat (mITT) population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. Last Observation carried forward (LOCF) method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 | 62.01 Percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24 | 23.24 Percentage of participants |
Comparison: Cochran-Mantel-Haenszel chi-square test, stratified by country, was used to calculate p-value. Assuming ACR50 response at Week 24 to be 23% in the DMARD combination therapy group and 37% in the etanercept + methotrexate group, a study enrolling 276 participants assigned to etanercept + methotrexate and 138 participants assigned to DMARD combination therapy has 80% power to reject the null hypothesis of no difference in response rates testing at the type I error = 0.05 level.p-value: <0.0001Cochran-Mantel-Haenszel
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Baseline and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline, Vitality domain | 12.46 Units on a scale | Standard Error 0.28 |
| Etanercept + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline, Mental component | 40.50 Units on a scale | Standard Error 0.78 |
| Etanercept + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline, Physical component | 30.42 Units on a scale | Standard Error 0.5 |
| Etanercept + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Change at Week 24, Vitality domain | 3.79 Units on a scale | Standard Error 0.27 |
| Etanercept + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Change at Week 24, Mental component | 7.33 Units on a scale | Standard Error 0.73 |
| Etanercept + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Change at Week 24, Physical component | 12.44 Units on a scale | Standard Error 0.65 |
| DMARD + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Change at Week 24, Mental component | 3.32 Units on a scale | Standard Error 0.95 |
| DMARD + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline, Vitality domain | 12.39 Units on a scale | Standard Error 0.36 |
| DMARD + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Change at Week 24, Vitality domain | 2.36 Units on a scale | Standard Error 0.35 |
| DMARD + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline, Mental component | 40.41 Units on a scale | Standard Error 1 |
| DMARD + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Change at Week 24, Physical component | 7.36 Units on a scale | Standard Error 0.84 |
| DMARD + Methotrexate | Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24 | Baseline, Physical component | 30.18 Units on a scale | Standard Error 0.64 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for vitality domain at Week 24.p-value: 0.0003ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for mental component at Week 24.p-value: 0.0002ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for physical component at Week 24.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. CRP was analysed at a central laboratory.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -11.81 mg / dL | Standard Error 1.36 |
| Etanercept + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -12.98 mg / dL | Standard Error 1.31 |
| Etanercept + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -11.88 mg / dL | Standard Error 1.28 |
| Etanercept + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -12.32 mg / dL | Standard Error 1.18 |
| Etanercept + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -12.33 mg / dL | Standard Error 1.34 |
| Etanercept + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -12.31 mg / dL | Standard Error 1.18 |
| Etanercept + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 277, 139) | -13.39 mg / dL | Standard Error 1.3 |
| DMARD + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -7.06 mg / dL | Standard Error 1.51 |
| DMARD + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 277, 139) | -0.62 mg / dL | Standard Error 1.66 |
| DMARD + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -3.15 mg / dL | Standard Error 1.64 |
| DMARD + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -4.52 mg / dL | Standard Error 1.74 |
| DMARD + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -5.80 mg / dL | Standard Error 1.72 |
| DMARD + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -5.81 mg / dL | Standard Error 1.67 |
| DMARD + Methotrexate | Change From Baseline in CRP at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -4.39 mg / dL | Standard Error 1.52 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: 0.0002ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.p-value: 0.0007ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: 0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: 0.0021ANCOVA
Secondary
Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the ESR (mm/hour) and the participant's general health using a 100 mm-VAS. DAS28\<3.2 indicates low disease activity and DAS28\<2.6 remission.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -3.39 units on a scale | Standard Deviation 1.34 |
| Etanercept + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -3.42 units on a scale | Standard Deviation 1.32 |
| Etanercept + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -3.41 units on a scale | Standard Deviation 1.31 |
| Etanercept + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -3.38 units on a scale | Standard Deviation 1.33 |
| Etanercept + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -3.53 units on a scale | Standard Deviation 1.34 |
| Etanercept + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -3.43 units on a scale | Standard Deviation 1.26 |
| Etanercept + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -3.47 units on a scale | Standard Deviation 1.31 |
| Etanercept + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -3.41 units on a scale | Standard Deviation 1.4 |
| DMARD + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -3.51 units on a scale | Standard Deviation 1.29 |
| DMARD + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -3.08 units on a scale | Standard Deviation 1.29 |
| DMARD + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -3.47 units on a scale | Standard Deviation 1.34 |
| DMARD + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -3.33 units on a scale | Standard Deviation 1.18 |
| DMARD + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -3.28 units on a scale | Standard Deviation 1.37 |
| DMARD + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -3.42 units on a scale | Standard Deviation 1.16 |
| DMARD + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -3.47 units on a scale | Standard Deviation 1.29 |
| DMARD + Methotrexate | Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -3.36 units on a scale | Standard Deviation 1.27 |
Secondary
Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS\<1.6 remission.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | -3.13 units on a scale | Standard Deviation 1.28 |
| Etanercept + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | -3.21 units on a scale | Standard Deviation 1.24 |
| Etanercept + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | -3.17 units on a scale | Standard Deviation 1.19 |
| Etanercept + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | -3.18 units on a scale | Standard Deviation 1.28 |
| Etanercept + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | -3.29 units on a scale | Standard Deviation 1.27 |
| Etanercept + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | -3.24 units on a scale | Standard Deviation 1.23 |
| Etanercept + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | -3.28 units on a scale | Standard Deviation 1.22 |
| Etanercept + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | -3.23 units on a scale | Standard Deviation 1.32 |
| DMARD + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | -3.35 units on a scale | Standard Deviation 1.38 |
| DMARD + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | -2.94 units on a scale | Standard Deviation 1.25 |
| DMARD + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | -3.26 units on a scale | Standard Deviation 1.38 |
| DMARD + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | -3.19 units on a scale | Standard Deviation 1.12 |
| DMARD + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | -3.18 units on a scale | Standard Deviation 1.41 |
| DMARD + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | -3.26 units on a scale | Standard Deviation 1.19 |
| DMARD + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | -3.31 units on a scale | Standard Deviation 1.31 |
| DMARD + Methotrexate | Change From Baseline in DAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | -3.24 units on a scale | Standard Deviation 1.23 |
Secondary
Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from the number of swollen joints and painful joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour; mm/hour) and the participant's general health using a 100 mm-visual analog scale (VAS). DAS28\<3.2 indicates low disease activity and DAS28\<2.6 remission.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -2.59 units on a scale | Standard Error 0.09 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -3.01 units on a scale | Standard Error 0.09 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | -2.15 units on a scale | Standard Error 0.08 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -3.15 units on a scale | Standard Error 0.09 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -2.82 units on a scale | Standard Error 0.09 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -3.20 units on a scale | Standard Error 0.09 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | -1.50 units on a scale | Standard Error 0.07 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -1.70 units on a scale | Standard Error 0.12 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | -0.67 units on a scale | Standard Error 0.09 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | -1.27 units on a scale | Standard Error 0.1 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -1.54 units on a scale | Standard Error 0.11 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -1.83 units on a scale | Standard Error 0.12 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -1.84 units on a scale | Standard Error 0.12 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -1.84 units on a scale | Standard Error 0.12 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using the ritchie articular index (RAI), number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS≤2.4 indicates low disease activity and DAS\<1.6 remission.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | -2.45 units on a scale | Standard Error 0.07 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | -2.82 units on a scale | Standard Error 0.08 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | -2.07 units on a scale | Standard Error 0.07 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | -2.95 units on a scale | Standard Error 0.08 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | -2.67 units on a scale | Standard Error 0.08 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | -2.97 units on a scale | Standard Error 0.08 |
| Etanercept + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | -1.42 units on a scale | Standard Error 0.07 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | -1.72 units on a scale | Standard Error 0.1 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | -0.65 units on a scale | Standard Error 0.09 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | -1.29 units on a scale | Standard Error 0.09 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | -1.55 units on a scale | Standard Error 0.1 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | -1.79 units on a scale | Standard Error 0.1 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | -1.86 units on a scale | Standard Error 0.1 |
| DMARD + Methotrexate | Change From Baseline in Disease Activity Score (DAS) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | -1.85 units on a scale | Standard Error 0.1 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 141) | -96.13 min | Standard Error 7.84 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 141) | -96.77 min | Standard Error 8.13 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 141) | -74.79 min | Standard Error 7.95 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 141) | -103.3 min | Standard Error 7.3 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 141) | -100.2 min | Standard Error 7.32 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 141) | -102.1 min | Standard Error 8.08 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 276, 137) | -60.59 min | Standard Error 8.31 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 141) | -53.66 min | Standard Error 10.37 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 276, 137) | -11.17 min | Standard Error 10.71 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 141) | -35.63 min | Standard Error 10.21 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 141) | -58.55 min | Standard Error 10.06 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 141) | -64.29 min | Standard Error 9.39 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 141) | -55.90 min | Standard Error 10.44 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 141) | -58.21 min | Standard Error 9.37 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 2.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 4.p-value: 0.0007ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: 0.0009ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 12.p-value: 0.0007ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: 0.0005ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 20.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The duration of morning stiffness was determined over the preceding 2 days using a 2-question worksheet.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 125) | -105.39 min | Standard Deviation 189.12 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 125) | -105.75 min | Standard Deviation 199.9 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 125) | -104.18 min | Standard Deviation 201.17 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 125) | -98.83 min | Standard Deviation 202.56 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -125.07 min | Standard Deviation 262.93 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -132.32 min | Standard Deviation 243.81 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -130.55 min | Standard Deviation 267.87 |
| Etanercept + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -118.79 min | Standard Deviation 294.73 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -90.88 min | Standard Deviation 206.55 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 125) | -87.89 min | Standard Deviation 162.76 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -76.49 min | Standard Deviation 226.83 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 125) | -97.61 min | Standard Deviation 164.68 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -89.53 min | Standard Deviation 196.35 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 125) | -89.61 min | Standard Deviation 170.16 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -84.53 min | Standard Deviation 205.7 |
| DMARD + Methotrexate | Change From Baseline in Duration of Morning Stiffness at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 125) | -91.53 min | Standard Deviation 181.67 |
Secondary
Change From Baseline in Erosion Score Using vdH 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). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Week 24
Population: xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Erosion Score Using vdH mTSS at Week 24 | 0.42 units on a scale | Standard Error 0.22 |
| DMARD + Methotrexate | Change From Baseline in Erosion Score Using vdH mTSS at Week 24 | 1.14 units on a scale | Standard Error 0.29 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.p-value: 0.0044ANCOVA
Secondary
Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -26.66 mm | Standard Error 1.55 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -29.10 mm | Standard Error 1.68 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -21.54 mm | Standard Error 1.59 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -30.74 mm | Standard Error 1.61 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -27.40 mm | Standard Error 1.63 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -29.57 mm | Standard Error 1.64 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -18.64 mm | Standard Error 1.48 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -17.26 mm | Standard Error 2.1 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -6.29 mm | Standard Error 1.9 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -10.44 mm | Standard Error 2.04 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -16.04 mm | Standard Error 1.98 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -16.45 mm | Standard Error 2.08 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -16.87 mm | Standard Error 2.15 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -18.95 mm | Standard Error 2.06 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: no fatigue, 100 mm: a great deal of fatigue) how much of a problem had fatigue or tiredness been for them in the preceding week.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -30.76 mm | Standard Deviation 29.09 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -29.03 mm | Standard Deviation 31.59 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -28.95 mm | Standard Deviation 31.51 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -29.44 mm | Standard Deviation 31.48 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -30.75 mm | Standard Deviation 30.78 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -30.37 mm | Standard Deviation 31.42 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -30.87 mm | Standard Deviation 30.83 |
| Etanercept + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -30.52 mm | Standard Deviation 31.26 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -30.35 mm | Standard Deviation 30.65 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -23.69 mm | Standard Deviation 29.1 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -28.38 mm | Standard Deviation 31.05 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -25.32 mm | Standard Deviation 30.94 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -27.38 mm | Standard Deviation 29.51 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -28.74 mm | Standard Deviation 31.19 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -30.61 mm | Standard Deviation 30.08 |
| DMARD + Methotrexate | Change From Baseline in Fatigue VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -28.17 mm | Standard Deviation 28.16 |
Secondary
Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -28.17 mm | Standard Error 1.6 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -32.69 mm | Standard Error 1.66 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -25.23 mm | Standard Error 1.49 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -34.69 mm | Standard Error 1.5 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -30.54 mm | Standard Error 1.57 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -33.71 mm | Standard Error 1.58 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -20.51 mm | Standard Error 1.43 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -19.27 mm | Standard Error 2.01 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -8.75 mm | Standard Error 1.82 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -13.11 mm | Standard Error 1.9 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -17.00 mm | Standard Error 2.04 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -19.60 mm | Standard Error 2 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -21.04 mm | Standard Error 2.11 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -20.04 mm | Standard Error 1.91 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: very well, 100 mm: extremely bad) in general how they rated their health over the preceding 2-3 weeks.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -34.48 mm | Standard Deviation 29.6 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -33.47 mm | Standard Deviation 27.53 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -33.53 mm | Standard Deviation 28.05 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -33.25 mm | Standard Deviation 28.44 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -34.79 mm | Standard Deviation 29.13 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -34.84 mm | Standard Deviation 27.07 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -34.86 mm | Standard Deviation 27.41 |
| Etanercept + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -36.25 mm | Standard Deviation 27.09 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -36.35 mm | Standard Deviation 27.57 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -31.02 mm | Standard Deviation 29.91 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -34.78 mm | Standard Deviation 26.96 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -31.51 mm | Standard Deviation 25.99 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -32.11 mm | Standard Deviation 27.75 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -34.33 mm | Standard Deviation 27.4 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -35.30 mm | Standard Deviation 27.6 |
| DMARD + Methotrexate | Change From Baseline in General Health VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -33.11 mm | Standard Deviation 27.12 |
Secondary
Change From Baseline in HAQ Score at Week 24
HAQ: self-reported, valid assessment of functional disability in rheumatoid arthritis. Assessed based on ability of participants to perform daily activities in 8 categories: dressing, arising, eating, walking, reaching, gripping, hygiene, and carrying out daily activities. HAQ score range: 0-3: without any difficulty: 0, with some difficulty: 1, with much difficulty: 2, unable to do: 3. HAQ total scores expressed as overall mean score with range 0-3: 0-0.25: normal functioning; 0.25-0.5: mild functional limitation; 0.5-1: moderate functional limitation; more than 1: significant functional limitation.
Time frame: Baseline and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in HAQ Score at Week 24 | Baseline | 1.55 Units on a scale | Standard Error 0.05 |
| Etanercept + Methotrexate | Change From Baseline in HAQ Score at Week 24 | Change at Week 24 | -0.85 Units on a scale | Standard Error 0.04 |
| DMARD + Methotrexate | Change From Baseline in HAQ Score at Week 24 | Baseline | 1.51 Units on a scale | Standard Error 0.07 |
| DMARD + Methotrexate | Change From Baseline in HAQ Score at Week 24 | Change at Week 24 | -0.51 Units on a scale | Standard Error 0.06 |
Comparison: Analysis of covariance (ANCOVA) model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Joint Space Narrowing Score Using vdH 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). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS from Baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Week 24
Population: xITT population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24 | -0.01 units on a scale | Standard Error 0.22 |
| DMARD + Methotrexate | Change From Baseline in Joint Space Narrowing Score Using vdH mTSS at Week 24 | 0.23 units on a scale | Standard Error 0.28 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value.p-value: 0.1975ANCOVA
Secondary
Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -17.47 units on a scale | Standard Error 0.63 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -19.44 units on a scale | Standard Error 0.66 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -15.01 units on a scale | Standard Error 0.68 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -20.06 units on a scale | Standard Error 0.62 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -18.70 units on a scale | Standard Error 0.63 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -19.77 units on a scale | Standard Error 0.64 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -10.28 units on a scale | Standard Error 0.71 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -12.83 units on a scale | Standard Error 0.82 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -5.65 units on a scale | Standard Error 0.91 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -9.99 units on a scale | Standard Error 0.87 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -12.27 units on a scale | Standard Error 0.8 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -13.82 units on a scale | Standard Error 0.81 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -14.00 units on a scale | Standard Error 0.85 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -13.85 units on a scale | Standard Error 0.79 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Painful joint count is a physical assessment of the ACR-specified 68 joint set for tenderness/pain. Each joint is rated as either painful or not painful with the total number of painful joints reported as the score. Score range is from 0-68 with lower scores indicating the better outcome.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -21.14 units on a scale | Standard Deviation 11.76 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -21.47 units on a scale | Standard Deviation 11.75 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -21.43 units on a scale | Standard Deviation 11.91 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -21.10 units on a scale | Standard Deviation 12.42 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -21.55 units on a scale | Standard Deviation 11.93 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -21.67 units on a scale | Standard Deviation 11.91 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -21.74 units on a scale | Standard Deviation 11.82 |
| Etanercept + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -21.44 units on a scale | Standard Deviation 12.13 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -23.96 units on a scale | Standard Deviation 13.25 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -21.43 units on a scale | Standard Deviation 13.65 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -23.02 units on a scale | Standard Deviation 12.87 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -22.50 units on a scale | Standard Deviation 12.75 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -22.72 units on a scale | Standard Deviation 12.94 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -23.72 units on a scale | Standard Deviation 12.74 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -23.51 units on a scale | Standard Deviation 13.13 |
| DMARD + Methotrexate | Change From Baseline in Painful Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -22.90 units on a scale | Standard Deviation 12.78 |
Secondary
Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -27.66 mm | Standard Error 1.48 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -39.86 mm | Standard Error 1.62 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -36.05 mm | Standard Error 1.6 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -40.59 mm | Standard Error 1.57 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -31.58 mm | Standard Error 1.6 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -40.91 mm | Standard Error 1.62 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -37.24 mm | Standard Error 1.65 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -23.97 mm | Standard Error 2.08 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -10.46 mm | Standard Error 1.9 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -16.30 mm | Standard Error 2.04 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -23.45 mm | Standard Error 2.05 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -23.74 mm | Standard Error 2.11 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -24.30 mm | Standard Error 2.07 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -24.75 mm | Standard Error 2.01 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participants had to indicate on a 100 mm-VAS (0 mm: no pain, 100 mm: pain as bad as it could be) the amount of pain they experienced over the preceding 2-3 days.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -41.66 mm | Standard Deviation 27.84 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -40.49 mm | Standard Deviation 27.84 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -39.98 mm | Standard Deviation 27.23 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -40.38 mm | Standard Deviation 28.94 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -42.37 mm | Standard Deviation 29.14 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -41.99 mm | Standard Deviation 27.73 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -42.27 mm | Standard Deviation 26.65 |
| Etanercept + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -41.95 mm | Standard Deviation 28.56 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -40.57 mm | Standard Deviation 26.81 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -36.89 mm | Standard Deviation 29.64 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -38.55 mm | Standard Deviation 28.17 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -36.63 mm | Standard Deviation 27.71 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -36.92 mm | Standard Deviation 27.55 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -39.36 mm | Standard Deviation 26.85 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -39.85 mm | Standard Deviation 27.69 |
| DMARD + Methotrexate | Change From Baseline in Pain VAS at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -37.17 mm | Standard Deviation 27.12 |
Secondary
Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -4.14 units on a scale | Standard Error 0.12 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -4.49 units on a scale | Standard Error 0.13 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -3.69 units on a scale | Standard Error 0.12 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -4.64 units on a scale | Standard Error 0.12 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -4.25 units on a scale | Standard Error 0.13 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -4.75 units on a scale | Standard Error 0.13 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -2.68 units on a scale | Standard Error 0.12 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -2.44 units on a scale | Standard Error 0.17 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -1.38 units on a scale | Standard Error 0.15 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -2.21 units on a scale | Standard Error 0.16 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -2.63 units on a scale | Standard Error 0.15 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -2.67 units on a scale | Standard Error 0.17 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -2.84 units on a scale | Standard Error 0.16 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -2.85 units on a scale | Standard Error 0.16 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participant's global disease activity was estimated over the preceding 2-3 days on a scale from 0 (no disease activity) to 10 (extreme disease activity) by the physician.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -5.03 units on a scale | Standard Deviation 1.96 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -5.14 units on a scale | Standard Deviation 1.91 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -5.08 units on a scale | Standard Deviation 1.97 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -5.18 units on a scale | Standard Deviation 1.98 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -5.25 units on a scale | Standard Deviation 2.01 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -5.16 units on a scale | Standard Deviation 1.87 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -5.26 units on a scale | Standard Deviation 1.86 |
| Etanercept + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -5.22 units on a scale | Standard Deviation 2.08 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -5.18 units on a scale | Standard Deviation 2 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -4.42 units on a scale | Standard Deviation 1.99 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -5.13 units on a scale | Standard Deviation 2.09 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -4.79 units on a scale | Standard Deviation 2.09 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -5.01 units on a scale | Standard Deviation 2.05 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -5.02 units on a scale | Standard Deviation 1.84 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -5.18 units on a scale | Standard Deviation 1.92 |
| DMARD + Methotrexate | Change From Baseline in Physician Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -4.97 units on a scale | Standard Deviation 1.82 |
Secondary
Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 2.93 units on a scale | Standard Error 0.15 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 3.24 units on a scale | Standard Error 0.15 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 3.39 units on a scale | Standard Error 0.16 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 1.84 units on a scale | Standard Error 0.19 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 2.24 units on a scale | Standard Error 0.2 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Bodily Pain Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 2.00 units on a scale | Standard Error 0.21 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 8, Week 16, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 3.22 units on a scale | Standard Error 0.25 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 3.62 units on a scale | Standard Error 0.25 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 3.95 units on a scale | Standard Error 0.26 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 2.25 units on a scale | Standard Error 0.32 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 2.56 units on a scale | Standard Error 0.32 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey General Health Perceptions Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 2.14 units on a scale | Standard Error 0.34 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: 0.0066ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: 0.0036ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 50, Week 76, Week 102, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 50 (N: 259, 126) | 8.28 units on a scale | Standard Deviation 11.62 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 76 (N: 259, 126) | 7.39 units on a scale | Standard Deviation 12.71 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 102 (N: 241, 120) | 7.19 units on a scale | Standard Deviation 12.49 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 128 (N: 241, 120) | 7.32 units on a scale | Standard Deviation 12.86 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 128 (N: 241, 120) | 6.42 units on a scale | Standard Deviation 11.48 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 50 (N: 259, 126) | 5.61 units on a scale | Standard Deviation 9.95 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 102 (N: 241, 120) | 6.05 units on a scale | Standard Deviation 11.61 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 76 (N: 259, 126) | 6.61 units on a scale | Standard Deviation 10.66 |
Secondary
Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 6.85 units on a scale | Standard Error 0.65 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 6.70 units on a scale | Standard Error 0.68 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 7.33 units on a scale | Standard Error 0.73 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 2.98 units on a scale | Standard Error 0.84 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 4.51 units on a scale | Standard Error 0.87 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Component Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 3.32 units on a scale | Standard Error 0.95 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: 0.0264ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: 0.0002ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 3.21 units on a scale | Standard Error 0.3 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 3.62 units on a scale | Standard Error 0.3 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 3.59 units on a scale | Standard Error 0.33 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 1.25 units on a scale | Standard Error 0.38 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 2.21 units on a scale | Standard Error 0.39 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Mental Health Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 1.81 units on a scale | Standard Error 0.42 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: 0.0013ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: 0.0002ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 50, Week 76, Week 102, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 50 (N: 259, 126) | 13.07 units on a scale | Standard Deviation 10.19 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 76 (N: 259, 126) | 12.84 units on a scale | Standard Deviation 10.77 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 102 (N: 241, 120) | 13.77 units on a scale | Standard Deviation 10.17 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 128 (N: 241, 120) | 13.47 units on a scale | Standard Deviation 10.64 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 128 (N: 241, 120) | 12.10 units on a scale | Standard Deviation 9.68 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 50 (N: 259, 126) | 12.32 units on a scale | Standard Deviation 9.59 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 102 (N: 241, 120) | 12.28 units on a scale | Standard Deviation 9.84 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 50, Week 76, Week 102, and Week 128 | Week 76 (N: 259, 126) | 11.29 units on a scale | Standard Deviation 10.37 |
Secondary
Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 10.08 units on a scale | Standard Error 0.6 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 12.26 units on a scale | Standard Error 0.63 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 12.44 units on a scale | Standard Error 0.65 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 7.04 units on a scale | Standard Error 0.78 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 7.98 units on a scale | Standard Error 0.82 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Component Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 7.36 units on a scale | Standard Error 0.84 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: 0.0005ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 3.97 units on a scale | Standard Error 0.3 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 4.95 units on a scale | Standard Error 0.32 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 5.06 units on a scale | Standard Error 0.33 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 2.63 units on a scale | Standard Error 0.39 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 3.08 units on a scale | Standard Error 0.41 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Physical Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 2.86 units on a scale | Standard Error 0.42 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: 0.0021ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 0.87 units on a scale | Standard Error 0.09 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 0.89 units on a scale | Standard Error 0.09 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 1.04 units on a scale | Standard Error 0.09 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 0.51 units on a scale | Standard Error 0.11 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 0.66 units on a scale | Standard Error 0.12 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Emotional Problems Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 0.46 units on a scale | Standard Error 0.11 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: 0.0061ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: 0.073ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 1.36 units on a scale | Standard Error 0.12 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 1.67 units on a scale | Standard Error 0.12 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 1.65 units on a scale | Standard Error 0.12 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 0.88 units on a scale | Standard Error 0.15 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 1.08 units on a scale | Standard Error 0.15 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Role Limitations Due to Physical Health Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 0.90 units on a scale | Standard Error 0.15 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: 0.0062ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: 0.0007ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 1.51 units on a scale | Standard Error 0.12 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 1.45 units on a scale | Standard Error 0.13 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 1.60 units on a scale | Standard Error 0.12 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 0.77 units on a scale | Standard Error 0.15 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 0.95 units on a scale | Standard Error 0.16 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Social Functioning Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 0.82 units on a scale | Standard Error 16 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: 0.0073ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: <0.0001ANCOVA
Secondary
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 50, Week 76, Week 102, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 76 (N: 259, 126) | 3.71 units on a scale | Standard Deviation 4.83 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 102 (N: 241, 120) | 4.00 units on a scale | Standard Deviation 4.55 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 128 (N: 241, 120) | 3.89 units on a scale | Standard Deviation 4.95 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 50 (N: 259, 126) | 4.08 units on a scale | Standard Deviation 4.72 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 50 (N: 259, 126) | 3.56 units on a scale | Standard Deviation 4.04 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 76 (N: 259, 126) | 3.49 units on a scale | Standard Deviation 4.16 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 128 (N: 241, 120) | 3.62 units on a scale | Standard Deviation 4.28 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 50, Week 76, Week 102, and Week 128 | Week 102 (N: 241, 120) | 3.60 units on a scale | Standard Deviation 4.64 |
Secondary
Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24
The SF-36 is standardized 36-item survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health perception, vitality, and mental health. Domain scores range from 0-100, with greater scores reflecting better health status. Two additional overall summary scores - physical and mental component scores - were also obtained. Summary scores are standardized where the general population mean is 50 with a standard deviation of 10. Greater scores again indicate better health status.
Time frame: Week 8, Week 16, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 3.43 units on a scale | Standard Error 0.26 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 3.90 units on a scale | Standard Error 0.26 |
| Etanercept + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 3.79 units on a scale | Standard Error 0.27 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24 | Week 8 (N: 278, 138) | 2.00 units on a scale | Standard Error 0.33 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24 | Week 16 (N: 278, 138) | 2.37 units on a scale | Standard Error 0.34 |
| DMARD + Methotrexate | Change From Baseline in SF-36 Health Survey Vitality Domain Score at Week 8, Week 16, and Week 24 | Week 24 (N: 278, 138) | 2.36 units on a scale | Standard Error 0.35 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 8.p-value: 0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 16.p-value: <0.0001ANCOVA
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-value. Statistical analysis presented above for Week 24.p-value: 0.0003ANCOVA
Secondary
Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 8 (N: 279, 142) | -3.13 units on a scale | Standard Error 0.16 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 16 (N: 279, 142) | -3.55 units on a scale | Standard Error 0.16 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 4 (N: 279, 142) | -2.69 units on a scale | Standard Error 0.15 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 20 (N: 279, 142) | -3.83 units on a scale | Standard Error 0.15 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 12 (N: 279, 142) | -3.35 units on a scale | Standard Error 0.16 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 24 (N: 279, 142) | -3.87 units on a scale | Standard Error 0.16 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 2 (N: 278, 140) | -2.14 units on a scale | Standard Error 0.14 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 24 (N: 279, 142) | -2.31 units on a scale | Standard Error 0.21 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 2 (N: 278, 140) | -1.01 units on a scale | Standard Error 0.18 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 4 (N: 279, 142) | -1.54 units on a scale | Standard Error 0.19 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 8 (N: 279, 142) | -1.93 units on a scale | Standard Error 0.2 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 12 (N: 279, 142) | -2.20 units on a scale | Standard Error 0.21 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 16 (N: 279, 142) | -2.33 units on a scale | Standard Error 0.21 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | Week 20 (N: 279, 142) | -2.34 units on a scale | Standard Error 0.2 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
The participant assessed overall arthritis activity on a scale from 0 (no disease activity) to 10 (extreme disease activity).
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -3.80 units on a scale | Standard Deviation 2.9 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -3.85 units on a scale | Standard Deviation 2.82 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -3.83 units on a scale | Standard Deviation 2.87 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -3.88 units on a scale | Standard Deviation 2.96 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -4.09 units on a scale | Standard Deviation 2.92 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -4.14 units on a scale | Standard Deviation 2.6 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -4.11 units on a scale | Standard Deviation 2.85 |
| Etanercept + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -4.28 units on a scale | Standard Deviation 2.73 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -3.82 units on a scale | Standard Deviation 2.8 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -3.27 units on a scale | Standard Deviation 3.16 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -3.91 units on a scale | Standard Deviation 2.93 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -3.44 units on a scale | Standard Deviation 2.9 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -3.71 units on a scale | Standard Deviation 3.11 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -3.72 units on a scale | Standard Deviation 3.07 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -3.83 units on a scale | Standard Deviation 2.92 |
| DMARD + Methotrexate | Change From Baseline in Subject Global Assessment Score at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -3.42 units on a scale | Standard Deviation 2.8 |
Secondary
Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -12.96 units on a scale | Standard Error 0.46 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -14.57 units on a scale | Standard Error 0.4 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -10.69 units on a scale | Standard Error 0.49 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -15.21 units on a scale | Standard Error 0.4 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -14.07 units on a scale | Standard Error 0.43 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -15.07 units on a scale | Standard Error 0.42 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -7.11 units on a scale | Standard Error 0.56 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -8.62 units on a scale | Standard Error 0.55 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | -3.15 units on a scale | Standard Error 0.72 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | -6.98 units on a scale | Standard Error 0.63 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -8.23 units on a scale | Standard Error 0.59 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -9.42 units on a scale | Standard Error 0.56 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -9.78 units on a scale | Standard Error 0.52 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -9.57 units on a scale | Standard Error 0.51 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Swollen joint count is a physical assessment of the ACR-specified 66 joint set for swelling. Each joint is rated as either swollen or not swollen with the total number of swollen joints reported as the score. Score range is from 0-66 with lower scores indicating the better outcome.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -16.16 units on a scale | Standard Deviation 8.75 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -16.54 units on a scale | Standard Deviation 8.74 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -16.48 units on a scale | Standard Deviation 8.46 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -16.57 units on a scale | Standard Deviation 9.02 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -16.69 units on a scale | Standard Deviation 8.77 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -16.93 units on a scale | Standard Deviation 8.6 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -17.07 units on a scale | Standard Deviation 8.71 |
| Etanercept + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -16.58 units on a scale | Standard Deviation 8.99 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -18.45 units on a scale | Standard Deviation 11.17 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -16.01 units on a scale | Standard Deviation 10.3 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -18.03 units on a scale | Standard Deviation 10.64 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -17.40 units on a scale | Standard Deviation 9.57 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -17.76 units on a scale | Standard Deviation 11.71 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -18.02 units on a scale | Standard Deviation 10.27 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -18.22 units on a scale | Standard Deviation 10.84 |
| DMARD + Methotrexate | Change From Baseline in Swollen Joint Counts at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -17.71 units on a scale | Standard Deviation 10.32 |
Secondary
Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24
mTSS: sum of erosion and joint space narrowing (JSN) scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Each x-ray visit included 4 films, each of which were read by 2 readers. The mTSS was calculated by the images scored for erosions and JSN. An increase in mTSS 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 Week 24
Population: Radiographic intent-to-treat (xITT) population included all participants who took at least 1 dose of study drug and had evaluable radiographic data at Baseline and Week 24.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 | Baseline | 31.19 units on a scale | Standard Error 4.06 |
| Etanercept + Methotrexate | Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 | Week 24 | 0.40 units on a scale | Standard Error 0.36 |
| DMARD + Methotrexate | Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 | Baseline | 46.35 units on a scale | Standard Error 5.35 |
| DMARD + Methotrexate | Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24 | Week 24 | 1.37 units on a scale | Standard Error 0.47 |
Comparison: ANCOVA model on ranks of change in mTSS with treatment group and center main effects and the Baseline rank as covariate was used to calculate p-value.p-value: 0.027ANCOVA
Secondary
Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -18.68 mm/hour | Standard Error 1.03 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -20.48 mm/hour | Standard Error 1.07 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | -17.31 mm/hour | Standard Error 0.99 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -20.56 mm/hour | Standard Error 1.12 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -19.74 mm/hour | Standard Error 1.11 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -20.72 mm/hour | Standard Error 1.16 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | -13.16 mm/hour | Standard Error 0.96 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | -12.37 mm/hour | Standard Error 1.48 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | -4.35 mm/hour | Standard Error 1.24 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | -8.06 mm/hour | Standard Error 1.27 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | -10.11 mm/hour | Standard Error 1.31 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | -12.53 mm/hour | Standard Error 1.42 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | -12.87 mm/hour | Standard Error 1.37 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | -12.60 mm/hour | Standard Error 1.44 |
Comparison: ANCOVA model with Baseline as covariate and factors for treatment and country as class variables was used to calculate p-values. ANCOVA was ran at each time-point shown, however as p-values obtained were identical, only one p-value is presented (which is applicable to each time-point - Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 - independently).p-value: <0.0001ANCOVA
Secondary
Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hour. A higher rate is consistent with inflammation. ESR was performed at the investigative site using an ESR kit supplied by the centralized laboratory.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -19.56 mm/hour | Standard Deviation 18.4 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -18.48 mm/hour | Standard Deviation 19.62 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -18.26 mm/hour | Standard Deviation 18.56 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -17.78 mm/hour | Standard Deviation 18.74 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -18.23 mm/hour | Standard Deviation 19.04 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -15.20 mm/hour | Standard Deviation 20.32 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -15.65 mm/hour | Standard Deviation 19.83 |
| Etanercept + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -13.75 mm/hour | Standard Deviation 22.36 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | -15.48 mm/hour | Standard Deviation 20.59 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | -20.25 mm/hour | Standard Deviation 14.92 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | -17.08 mm/hour | Standard Deviation 19.74 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | -20.27 mm/hour | Standard Deviation 16.78 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | -15.30 mm/hour | Standard Deviation 21.7 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | -18.31 mm/hour | Standard Deviation 17.68 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | -16.63 mm/hour | Standard Deviation 19 |
| DMARD + Methotrexate | Change From Baseline in Westergren ESR at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | -17.54 mm/hour | Standard Deviation 20 |
Secondary
Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 73.84 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 84.23 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | 63.80 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 84.59 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 79.57 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 83.15 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | 47.84 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 50.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | 19.29 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | 34.51 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 49.30 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 54.93 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 57.75 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 58.45 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: <0.000195% CI: [2.37, 6.21]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [2.19, 5.11]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [1.9, 4.43]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [2.06, 4.96]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [2.46, 6.21]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [2.45, 6.22]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.13, 7.78]Fisher Exact
Secondary
Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR20 response: greater than or equal to 20 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 20 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 86.92 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 90.00 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 88.85 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 89.23 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 90.87 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 91.70 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 90.04 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 89.21 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 89.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 80.95 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 89.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 86.51 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 83.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 91.27 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 90.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR20 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 87.30 percentage of participants |
Secondary
Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 8 (N: 279, 142) | 42.29 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 16 (N: 279, 142) | 56.27 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 4 (N: 279, 142) | 31.54 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 20 (N: 279, 142) | 59.14 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 12 (N: 279, 142) | 52.33 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 24 (N: 279, 142) | 62.01 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 2 (N: 278, 140) | 15.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 24 (N: 279, 142) | 23.24 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 2 (N: 278, 140) | 2.86 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 4 (N: 279, 142) | 8.45 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 8 (N: 279, 142) | 16.90 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 12 (N: 279, 142) | 21.13 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 16 (N: 279, 142) | 24.65 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 2, Week 4, Week 8, Week 12, Week 16, and Week 20 | Week 20 (N: 279, 142) | 27.46 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: <0.000195% CI: [2.25, 18.2]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [2.62, 9.49]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [2.19, 5.94]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [2.57, 6.53]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [2.51, 6.16]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [2.46, 5.93]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.41, 8.53]Fisher Exact
Secondary
Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 67.31 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 65.77 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 68.46 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 67.31 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 73.44 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 73.44 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 72.61 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 70.54 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 65.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 53.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 60.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 60.32 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 59.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 62.70 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 61.67 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR50 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 58.73 percentage of participants |
Secondary
Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
ACR70 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and CRP.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 16.13 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 27.60 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | 7.17 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 30.11 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 20.07 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 34.77 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | 3.60 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 11.27 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 278, 140) | 0.71 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 279, 142) | 2.11 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 3.52 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 4.23 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 9.15 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 10.56 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: 0.108695% CI: [0.66, 40.9]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: 0.039295% CI: [1.04, 12.3]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [2.04, 13.6]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [2.39, 13.6]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [2.02, 7.09]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [2.02, 6.6]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [2.36, 7.46]Fisher Exact
Secondary
Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
ACR70 response: greater than or equal to 70 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 70 percent improvement from Baseline 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; participant's self-assessed disability (disability index of HAQ); and ESR.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 40.38 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 45.00 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 39.62 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 41.92 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 53.11 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 48.96 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 48.55 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 48.96 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 40.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 30.16 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 38.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 32.54 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 35.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 34.13 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 36.67 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving ACR70 Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 34.13 percentage of participants |
Secondary
Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission.
Time frame: Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24 | 28.78 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS<1.6 (Remission) Response at Week 24 | 4.93 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value.p-value: <0.000195% CI: [3.49, 17.39]Fisher Exact
Secondary
Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission.
Time frame: Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24 | 61.51 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS<2.4 (Low Disease Activity) Response at Week 24 | 20.42 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value.p-value: <0.000195% CI: [3.88, 10]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 10.04 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 20.43 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 4.32 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 28.67 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 14.7 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 25.09 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 1.45 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 3.52 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 0 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 2.11 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 4.23 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 5.63 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 5.63 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 6.34 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: 0.3054Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: 0.404495% CI: [0.58, 7.53]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: 0.038895% CI: [1.02, 6.26]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: 0.005995% CI: [1.31, 6.34]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [1.99, 9.29]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [2.88, 12.24]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.61, 23.32]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 33.85 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 36.54 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 38.46 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 33.46 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 45.64 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 36.93 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 39.42 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 39.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 33.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 22.22 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 34.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 26.19 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 30.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 26.19 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 36.67 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<2.6 (Remission) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 23.02 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 22.22 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 38.35 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 10.79 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 43.01 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 30.11 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 46.95 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 5.09 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 11.97 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 0.72 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 4.93 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 9.15 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 12.68 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 16.9 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 15.49 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: 0.02595% CI: [0.96, 56.88]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: 0.046695% CI: [1, 5.45]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: 0.000795% CI: [1.5, 5.36]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [1.7, 5.18]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [1.85, 5.05]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [2.47, 6.87]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.72, 11.38]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 53.08 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 54.62 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 55.38 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 56.92 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 60.58 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 56.43 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 56.85 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 57.68 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 55.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 37.3 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 50.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 45.24 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 45.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 50.79 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 50.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28<3.2 (Low Disease Activity) Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 44.44 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 93.91 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 96.06 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 89.93 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 96.77 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 95.34 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 95.70 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 80.36 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 73.94 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 47.48 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 69.01 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 74.65 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 79.58 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 78.87 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 78.17 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: <0.000195% CI: [2.9, 7.07]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [2.36, 6.8]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [2.82, 9.72]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [2.63, 10.47]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [3.16, 13.48]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [3.86, 18.17]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.94, 15.62]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 97.31 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 98.46 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 96.92 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 96.54 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 96.27 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 97.10 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 97.10 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 96.68 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 98.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 96.03 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 99.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 97.62 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 95.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 99.21 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 97.50 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 99.21 percentage of participants |
Secondary
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 87.46 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 92.47 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 78.78 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 93.55 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 89.96 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 90.32 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 57.09 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 61.97 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 26.62 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 44.37 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 58.45 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 62.68 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 68.31 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 64.79 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: <0.000195% CI: [2.35, 5.73]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [3, 7.22]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [3.05, 8.06]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [3.18, 8.96]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [3.23, 10.06]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [4.37, 14.2]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.4, 9.65]Fisher Exact
Secondary
Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28 calculated from number of swollen joints and painful joints using the 28 joints count, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS28\<3.2: low disease activity, DAS28\<2.6: remission.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 95.00 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 95.38 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 95.77 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 94.62 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 94.61 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 94.61 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 95.02 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 92.95 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 95.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 91.27 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 95.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 94.44 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 92.50 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 96.03 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 94.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS28 Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 92.86 percentage of participants |
Secondary
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | 95.68 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | 96.76 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | 90.97 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | 97.12 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | 95.32 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | 96.04 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | 79.93 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | 76.06 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | 53.24 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | 66.90 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | 78.87 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | 81.69 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | 83.10 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | 83.10 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: <0.000195% CI: [2.24, 5.46]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [2.91, 8.55]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [2.93, 12.02]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [2.27, 9.21]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [2.74, 13.48]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [3, 15.72]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.74, 15.63]Fisher Exact
Secondary
Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | 98.07 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | 98.46 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | 96.91 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | 96.53 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | 97.49 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | 98.74 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | 98.33 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | 97.07 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | 99.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | 96.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | 98.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | 98.41 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | 96.67 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | 99.21 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | 98.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥0.6 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | 98.41 percentage of participants |
Secondary
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | 84.89 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | 92.09 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | 78.34 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | 91.73 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | 87.77 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | 91.01 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | 57.66 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | 60.56 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | 30.22 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | 45.07 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | 58.45 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | 64.79 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | 67.61 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | 66.90 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: <0.000195% CI: [2.04, 4.86]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [2.85, 6.82]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [2.5, 6.38]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [2.37, 6.41]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [3.19, 9.76]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [3.16, 9.52]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.87, 11.21]Fisher Exact
Secondary
Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS calculated from number of painful joints using RAI, number of swollen joints using the same 44 joints as in RAI, ESR (mm/hour) and participant's general health using a 100 mm-VAS. DAS\<2.4: low disease activity, DAS\<1.6: remission.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | 95.37 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | 96.53 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | 95.75 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | 94.21 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | 94.56 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | 95.40 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | 97.49 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | 94.14 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | 95.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | 89.68 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | 94.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | 96.03 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | 94.17 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | 95.24 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | 97.50 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving DAS Improvement of ≥1.2 From Baseline at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | 96.03 percentage of participants |
Secondary
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline \>1.2.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 22.22 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 38.35 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 10.79 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 43.01 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 30.11 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 46.95 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 5.09 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 11.97 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 0.72 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 4.93 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 9.15 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 12.68 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 16.9 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 15.49 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: 0.02595% CI: [0.96, 56.88]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: 0.046695% CI: [1, 5.45]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: 0.000795% CI: [1.5, 5.36]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [1.7, 5.18]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [1.85, 5.05]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [2.47, 6.87]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.72, 11.38]Fisher Exact
Secondary
Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS28-based EULAR response was defined as: DAS28-value ≤3.2 and DAS28-improvement from Baseline \>1.2.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 53.08 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 54.62 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 55.38 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 56.92 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 60.58 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 56.43 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 56.85 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 57.68 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 55.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 37.3 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 50.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 45.24 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 45.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 50.79 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 50.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 44.44 percentage of participants |
Secondary
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline \>1.2.
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | 39.21 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | 56.12 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | 24.55 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | 58.99 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | 48.2 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | 61.15 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | 8.39 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | 20.42 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | 2.88 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | 7.75 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | 15.49 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | 22.54 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | 22.54 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | 24.65 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: 0.034995% CI: [1.05, 9.13]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [1.98, 7.6]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [2.1, 5.88]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [2.02, 5.06]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [2.78, 6.96]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [2.8, 6.9]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.82, 9.85]Fisher Exact
Secondary
Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Good DAS-based EULAR response was defined as: DAS-value ≤2.4 and DAS-improvement from Baseline \>1.2.
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | 73.36 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | 72.2 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | 72.97 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | 73.75 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | 76.57 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | 77.41 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | 76.57 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | 75.73 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | 70.00 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | 56.35 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | 68.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | 69.05 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | 66.67 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | 70.63 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | 70.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Good DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | 64.29 percentage of participants |
Secondary
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as: * DAS28-value ≤5.1 and DAS28-improvement from Baseline \>0.6 * DAS28-value \>5.1 and DAS28-improvement from Baseline \>1.2
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 88.89 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 93.91 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 81.29 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 94.62 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 91.4 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 91.76 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 64 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 279, 142) | 64.79 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 275, 139) | 29.5 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 278, 142) | 48.59 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 279, 142) | 60.56 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 279, 142) | 64.79 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 279, 142) | 68.31 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 279, 142) | 67.61 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: <0.000195% CI: [2.74, 6.6]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [2.94, 7.18]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [3.15, 8.61]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [3.36, 9.93]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [3.91, 13.09]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [4.5, 15.8]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.5, 10.47]Fisher Exact
Secondary
Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS28-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS28-based EULAR response was defined as: * DAS28-value ≤5.1 and DAS28-improvement from Baseline \>0.6 * DAS28-value \>5.1 and DAS28-improvement from Baseline \>1.2
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 95.77 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 96.15 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 96.15 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 95 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 95.85 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 95.02 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 95.44 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 92.95 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 241, 120) | 97.50 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 260, 126) | 93.65 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 241, 120) | 96.67 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 260, 126) | 95.24 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 241, 120) | 93.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 260, 126) | 96.83 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 241, 120) | 96.67 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS28-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 260, 126) | 96.83 percentage of participants |
Secondary
Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as: * DAS-value ≤3.7 and DAS-improvement from Baseline \>0.6 * DAS-value \>3.7 and DAS-improvement from Baseline \>1.2
Time frame: Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | 89.93 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | 93.88 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | 84.12 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | 94.6 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | 91.01 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | 92.45 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | 66.42 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 24 (N: 278, 142) | 65.49 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 2 (N: 274, 139) | 35.97 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 4 (N: 277, 142) | 52.11 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 8 (N: 278, 142) | 64.08 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 12 (N: 278, 142) | 69.72 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 16 (N: 278, 142) | 72.54 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good DAS-Based European League Against Rheumatism (EULAR) Response at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | Week 20 (N: 278, 142) | 73.94 percentage of participants |
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 2.p-value: <0.000195% CI: [2.3, 5.4]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 4.p-value: <0.000195% CI: [3.07, 7.71]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 8.p-value: <0.000195% CI: [2.98, 8.41]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 12.p-value: <0.000195% CI: [2.55, 7.58]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 16.p-value: <0.000195% CI: [3.15, 10.74]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 20.p-value: <0.000195% CI: [3.25, 11.73]Fisher Exact
Comparison: Fisher's exact test was used to calculate the p-value. Statistical analysis presented above for Week 24.p-value: <0.000195% CI: [3.67, 11.33]Fisher Exact
Secondary
Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
DAS-based EULAR response criteria were used to measure individual response as none, good, and moderate, depending on the extent of change from Baseline and the level of disease activity reached. Moderate or good DAS-based EULAR response was defined as: * DAS-value ≤3.7 and DAS-improvement from Baseline \>0.6 * DAS-value \>3.7 and DAS-improvement from Baseline \>1.2
Time frame: Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128
Population: mITT population (LOCF) was used. Phase 2 Year 1 (week 37-week 76)-sample size (Etanercept + Methotrexate, DMARD + Methotrexate: 260, 126) is different from Phase 2 Year 2 (week 89-week 128)-sample size (241, 120).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | 97.3 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | 97.3 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | 96.53 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | 95.37 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | 97.07 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | 97.49 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | 98.33 percentage of participants |
| Etanercept + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | 96.23 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 128 (N: 239, 120) | 98.33 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 37 (N: 259, 126) | 93.65 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 89 (N: 239, 120) | 97.50 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 50 (N: 259, 126) | 97.62 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 115 (N: 239, 120) | 96.67 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 63 (N: 259, 126) | 98.41 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 102 (N: 239, 120) | 97.50 percentage of participants |
| DMARD + Methotrexate | Percentage of Participants Achieving Moderate/Good Disease DAS-Based EULAR Response at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128 | Week 76 (N: 259, 126) | 97.62 percentage of participants |
Secondary
Summary of Changes in Therapy at the Beginning of Phase 2
The investigators were allowed to alter each participant's therapy at the beginning of Phase 2. Continuations, discontinuations and additions made to Phase 1 treatment regimen were summarized.
Time frame: Week 24
Population: mITT population included all participants who took at least 1 dose of study drug and had at least 1 post-randomization visit that included evaluation of tender and swollen joints and at least 3 of other 5 variables required to calculate ACR50. LOCF method was used. One participant was randomized to etanercept but received SSZ in Phase 1.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | No change: HCQ | NA participants |
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Added HCQ | 8 participants |
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | No change: SSZ | NA participants |
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Added SSZ | 3 participants |
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | No change: Methotrexate | 260 participants |
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Discontinued HCQ | NA participants |
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Added Etanercept | 1 participants |
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Discontinued SSZ | 1 participants |
| Etanercept + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | No change: Etanercept | 259 participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Discontinued SSZ | 51 participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | No change: Etanercept | NA participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | No change: HCQ | 29 participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | No change: Methotrexate | 126 participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | No change: SSZ | 11 participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Added Etanercept | 105 participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Added HCQ | NA participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Added SSZ | NA participants |
| DMARD + Methotrexate | Summary of Changes in Therapy at the Beginning of Phase 2 | Discontinued HCQ | 35 participants |