Rheumatoid Arthritis
Conditions
Brief summary
This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.
Interventions
DRUGEtanercept
50 mg etanercept once weekly + methotrexate
DRUGPlacebo
Placebo comparator once weekly + methotrexate
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has a current DAS28 equal to or less than 3.2. * Subject is currently receiving treatment with etanercept, either 25 mg twice weekly or 50 mg once weekly, for a minimum of 14 months at baseline * Subject is currently receiving oral, sc or intramuscular methotrexate once weekly, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.
Exclusion criteria
* Subject has earlier had an attempt of discontinuing etanercept for reasons of remission or low disease activity state. * Subject has received any disease-modifying anti-rheumatic drug, other than methotrexate, within one month before baseline. * Subject has had a dose of prednisone (or equivalent) \>7.5 mg/day or has received intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within one month of baseline.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participant Who Were Non-Failures | Week 48 | A participant was considered as non-failure if the calculated DAS28 \<=3.2 at all visits or if the calculated DAS28 \>3.2, the increase of calculated DAS28 from randomization (Week 0): was \<0.6 at all visit or was \>=0.6 but \<1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Remission or Low Disease Activity (LDA) | Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | Participants who had DAS28 less than or equal to (\<=) 3.2 were considered in remission or LDA state. |
| Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State | Randomization (Week 0) up to Week 48 | Participants who had DAS28 \<=3.2 were considered in remission or LDA state. Percentage of visits during which a participant was in remission or LDA state was calculated as number of visits in which participant was in remission or LDA divided by total number of visits multiplied by 100. |
| Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization | Randomization (Week 0) | DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 implied low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity and less than (\<) 2.6=remission. |
| Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | DAS28 calculated from SJC and PJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity and \<2.6=remission. |
| Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from randomization indicates an improvement. |
| Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from randomization indicates an improvement. |
| Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | PGA of disease activity was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 mm = extreme disease activity. |
| Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | Participants assessed the overall activity of their rheumatoid arthritis (RA) on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extreme disease activity. |
| Participant General Health Visual Analog Scale (VAS) at Randomization | Randomization (Week 0) | Participants answered in general how would you rate your health over the last 2-3 weeks? Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad. |
| Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | Participants answered in general how would you rate your health over the last 2-3 weeks? Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad. |
| Time to Treatment Failure (TTF) | Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48) | TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal. |
| Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be. |
| Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. The duration of morning stiffness was determined by asking the following questions: 1) Over the last 2 days, when did you wake in the morning? 2) Over the last 2 days, when were you able to resume your normal activities without stiffness? Increase in stiffness duration from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | 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 millimeter per hour (mm/hour). A higher rate is consistent with inflammation. |
| Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48 | The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is \<10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. |
| Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48 | Randomization (Week 0), Week 48 | 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). Change: scores at observation minus score at randomization. An increase in mTSS from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement. |
| Magnetic Resonance Imaging (MRI) Findings at Randomization | Randomization (Week 0) | MRI of hand/wrist of dominant hand scored for signs of synovitis (S-score), bone edema(O-score), bone erosions (E-score) as per outcome measures in RA clinical trials (OMERACT). S-score:0(normal)-3(severe) for distal radioulnar,radiocarpal,intercarpal-carpometacarpal,second-fifth metacarpophalangeal joints, total score(TS)0-21, higher score(HS)=severe synovitis. O-score:0(no volume increment)-3(100% volume increment) in 23 hand/wrist joints, TS 0-69, HS=more edema. E-score:0(no volume occupied by erosion)-10(100% volume occupied by erosion) in 23 hand/wrist joints, TS 0-230, HS=more erosion. |
| Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12 | Randomization (Week 0), Week 12 | MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. S-score: 0 (normal) to 3 (severe) for each of distal radioulnar, radiocarpal, intercarpal-carpometacarpal, second to fifth metacarpophalangeal joints; total score 0 to 21, higher score=severe synovitis. |
| Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12 | Randomization (Week 0), Week 12 | MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. O-score: 0 (no volume increment) to 3 (100% volume increment) in 23 hand/wrist joints; total score 0 to 69, higher scores=more edema. E-score: 0 (no volume occupied by erosion) to 10 (100% volume occupied by erosion) in 23 hand/wrist joints; total score 0 to 230, higher scores=more erosion. |
| Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Randomization (Week 0) up to Week 48 | Percentage of participants who were treatment failure over 48 weeks as per potentially predictor variables (at randomization) are reported: number of swollen joints/tender joints, DAS28, PGA, PtGA, participant general health VAS, participant pain VAS, clinical disease activity index (CDAI), simplified disease activity index (SDAI), ESR (mm/hour), plasma CRP (mg/L), sensitive serum CRP (mg/L), anti- cyclic citrullinated peptide (anti CCP, units/mL), cartilage oligomeric matrix protein (COMP, units/liter), S-score, O-score, E-score, Joint space narrowing score, erosion score, and mTSS. |
| Participant Pain Visual Analog Scale (VAS) at Randomization | Randomization (Week 0) | Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be. |
Countries
Denmark, Finland, Hungary, Iceland, Norway, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Entire Study Population Includes all participants who were enrolled in this study. | 91 |
| Total | 91 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Double-Blind (Week 0 to Failure/Week 48) | Adverse Event | 0 | 0 | 1 | 0 | 0 |
| Double-Blind (Week 0 to Failure/Week 48) | Other | 0 | 1 | 0 | 0 | 0 |
| Double-Blind (Week 0 to Failure/Week 48) | Withdrawal by Subject | 0 | 1 | 1 | 1 | 0 |
| OL Re-Treatment (Failure to Week 48) | Other | 0 | 0 | 0 | 0 | 1 |
| OL Re-Treatment (Failure to Week 48) | Protocol Violation | 0 | 0 | 0 | 0 | 1 |
| Open-Label (OL) Run-In(Week-8 to Week 0) | Did not enter double-blind period | 18 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Entire Study Population |
|---|---|
| Age Continuous | 56.14 years STANDARD_DEVIATION 11.6 |
| Sex: Female, Male Female | 65 Participants |
| Sex: Female, Male Male | 26 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 27 / 91 | 16 / 23 | 20 / 27 | 7 / 23 | 31 / 43 |
| serious Total, serious adverse events | 0 / 91 | 1 / 23 | 1 / 27 | 0 / 23 | 1 / 43 |
Outcome results
Primary
Percentage of Participant Who Were Non-Failures
A participant was considered as non-failure if the calculated DAS28 \<=3.2 at all visits or if the calculated DAS28 \>3.2, the increase of calculated DAS28 from randomization (Week 0): was \<0.6 at all visit or was \>=0.6 but \<1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.
Time frame: Week 48
Population: Modified intent-to-treat (m-ITT) analysis set included all randomized participants who received at least 1 dose of study medication after randomization and had at least 1 available evaluation after the first administration of study medication after randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept 50 mg - Period 2 | Percentage of Participant Who Were Non-Failures | 52.2 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participant Who Were Non-Failures | 44.4 percentage of participants |
| Placebo - Period 2 | Percentage of Participant Who Were Non-Failures | 13.0 percentage of participants |
Comparison: Analysis was performed using a generalized estimating equations (GEE) model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.p-value: 0.00795% CI: [1.72, 29.82]GEE Model
Comparison: Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.p-value: 0.36295% CI: [0.54, 5.41]GEE Model
Comparison: Analysis was performed using a GEE model, using a logit link, a binomial distribution and an auto-regressive correlation structure, with treatment groups, visits, their interaction, and the stratification factor as factors in the model.p-value: 0.04495% CI: [1.04, 16.99]GEE Model
Secondary
Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. Normal range of CRP is \<10 milligram per liter (mg/L). A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.00 mg/L |
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.00 mg/L |
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.00 mg/L |
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.00 mg/L |
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 2.00 mg/L |
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.00 mg/L |
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 20, 6) | 0.00 mg/L |
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.00 mg/L |
| Etanercept 50 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 3.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 20, 6) | 0.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.00 mg/L |
| Etanercept 25 mg - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.00 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 20, 6) | 0.00 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 1.60 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.94 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.33 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | -1.42 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 1.00 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 2.74 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 3.49 mg/L |
| Placebo - Period 2 | Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 1.20 mg/L |
Secondary
Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
DAS28 calculated from SJC and PJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity and \<2.6=remission.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 0.11 units on a scale | Standard Error 0.24 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | 0.38 units on a scale | Standard Error 0.25 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 0.41 units on a scale | Standard Error 0.25 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | -0.00 units on a scale | Standard Error 0.26 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 0.24 units on a scale | Standard Error 0.26 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | 0.18 units on a scale | Standard Error 0.26 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 0.14 units on a scale | Standard Error 0.27 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 0.46 units on a scale | Standard Error 0.27 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 0.64 units on a scale | Standard Error 0.27 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 0.45 units on a scale | Standard Error 0.29 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | 0.66 units on a scale | Standard Error 0.28 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 0.74 units on a scale | Standard Error 0.28 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | 1.00 units on a scale | Standard Error 0.28 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 0.47 units on a scale | Standard Error 0.25 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | 0.32 units on a scale | Standard Error 0.26 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 0.92 units on a scale | Standard Error 0.29 |
| Placebo - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 1.14 units on a scale | Standard Error 0.69 |
| Placebo - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | 1.33 units on a scale | Standard Error 0.53 |
| Placebo - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 0.85 units on a scale | Standard Error 0.36 |
| Placebo - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | 1.02 units on a scale | Standard Error 0.69 |
| Placebo - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 1.02 units on a scale | Standard Error 0.8 |
| Placebo - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | 0.45 units on a scale | Standard Error 0.8 |
| Placebo - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 1.12 units on a scale | Standard Error 0.69 |
| Placebo - Period 2 | Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 1.17 units on a scale | Standard Error 0.8 |
Secondary
Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
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 millimeter per hour (mm/hour). A higher rate is consistent with inflammation.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 15, 19, 3) | 1.00 mm/hour |
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 2.00 mm/hour |
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | -1.50 mm/hour |
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | -1.00 mm/hour |
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=22,27,23) | 10.00 mm/hour |
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | -1.50 mm/hour |
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 17, 21, 6) | 0.00 mm/hour |
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 21, 26, 15) | 0.00 mm/hour |
| Etanercept 50 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.00 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.00 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=22,27,23) | 8.00 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 21, 26, 15) | 0.00 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 17, 21, 6) | 0.00 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 15, 19, 3) | 1.00 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.00 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 1.50 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.00 mm/hour |
| Etanercept 25 mg - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 1.00 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 17, 21, 6) | 0.50 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=22,27,23) | 8.00 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | -2.50 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 21, 26, 15) | 2.00 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | -2.50 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 1.00 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 15, 19, 3) | 2.00 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | -0.50 mm/hour |
| Placebo - Period 2 | Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 1.00 mm/hour |
Secondary
Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12
MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. O-score: 0 (no volume increment) to 3 (100% volume increment) in 23 hand/wrist joints; total score 0 to 69, higher scores=more edema. E-score: 0 (no volume occupied by erosion) to 10 (100% volume occupied by erosion) in 23 hand/wrist joints; total score 0 to 230, higher scores=more erosion.
Time frame: Randomization (Week 0), Week 12
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12 | Change at Week 12: O-Score | 0.00 units on a scale |
| Etanercept 50 mg - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12 | Change at Week 12: E-Score | 0.00 units on a scale |
| Etanercept 25 mg - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12 | Change at Week 12: O-Score | 0.00 units on a scale |
| Etanercept 25 mg - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12 | Change at Week 12: E-Score | 0.00 units on a scale |
| Placebo - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12 | Change at Week 12: O-Score | -3.00 units on a scale |
| Placebo - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12 | Change at Week 12: E-Score | 0.00 units on a scale |
Secondary
Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12
MRI of hand/wrist of dominant hand was scored for signs of synovitis (S-score), bone edema (O-score), and bone erosions (E-score) as per OMERACT. S-score: 0 (normal) to 3 (severe) for each of distal radioulnar, radiocarpal, intercarpal-carpometacarpal, second to fifth metacarpophalangeal joints; total score 0 to 21, higher score=severe synovitis.
Time frame: Randomization (Week 0), Week 12
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12 | -0.16 units on a scale | Standard Error 0.56 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12 | 1.36 units on a scale | Standard Error 0.68 |
| Placebo - Period 2 | Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12 | -0.29 units on a scale | Standard Error 1.15 |
Secondary
Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48
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). Change: scores at observation minus score at randomization. An increase in mTSS from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Randomization (Week 0), Week 48
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48 | Randomization (n=19, 22, 17) | 19.50 units on a scale |
| Etanercept 50 mg - Period 2 | Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48 | Change at Week 48 (n= 9, 9, 1) | 0.00 units on a scale |
| Etanercept 25 mg - Period 2 | Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48 | Randomization (n=19, 22, 17) | 54.25 units on a scale |
| Etanercept 25 mg - Period 2 | Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48 | Change at Week 48 (n= 9, 9, 1) | 0.00 units on a scale |
| Placebo - Period 2 | Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48 | Randomization (n=19, 22, 17) | 23.00 units on a scale |
| Placebo - Period 2 | Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48 | Change at Week 48 (n= 9, 9, 1) | -1.00 units on a scale |
Secondary
Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. The duration of morning stiffness was determined by asking the following questions: 1) Over the last 2 days, when did you wake in the morning? 2) Over the last 2 days, when were you able to resume your normal activities without stiffness? Increase in stiffness duration from randomization represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 minutes |
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 11, 2) | 0.0 minutes |
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.0 minutes |
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 minutes |
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,26,23) | 10.0 minutes |
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 11, 2) | 0.0 minutes |
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 20, 5) | 0.0 minutes |
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 25, 15) | 0.0 minutes |
| Etanercept 50 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.0 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,26,23) | 0.5 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 25, 15) | 0.0 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 20, 5) | 0.0 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.0 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.0 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 11, 2) | 0.0 minutes |
| Etanercept 25 mg - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 11, 2) | 0.0 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 20, 5) | 1.0 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,26,23) | 5.0 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | -2.5 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 25, 15) | 0.0 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 11, 2) | -5.0 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 11, 2) | -2.5 minutes |
| Placebo - Period 2 | Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | -5.0 minutes |
Secondary
Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Participants answered in general how would you rate your health over the last 2-3 weeks? Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 8.21 mm | Standard Error 4.74 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | 4.09 mm | Standard Error 5.03 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 8.14 mm | Standard Error 5.16 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | 9.86 mm | Standard Error 5.42 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 9.09 mm | Standard Error 5.38 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | 9.18 mm | Standard Error 5.49 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 8.15 mm | Standard Error 5.62 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 12.04 mm | Standard Error 5.63 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 12.29 mm | Standard Error 4.93 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 14.01 mm | Standard Error 5.26 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | 9.70 mm | Standard Error 5.09 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 13.84 mm | Standard Error 5.11 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | 17.49 mm | Standard Error 5.16 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 8.67 mm | Standard Error 4.7 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | 10.21 mm | Standard Error 4.86 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 16.09 mm | Standard Error 5.26 |
| Placebo - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 11.30 mm | Standard Error 13.7 |
| Placebo - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | 18.47 mm | Standard Error 10.06 |
| Placebo - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 8.37 mm | Standard Error 6.59 |
| Placebo - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | -0.15 mm | Standard Error 13.71 |
| Placebo - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 29.87 mm | Standard Error 16.32 |
| Placebo - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | -3.20 mm | Standard Error 16.31 |
| Placebo - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 6.88 mm | Standard Error 13.71 |
| Placebo - Period 2 | Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 6.36 mm | Standard Error 16.33 |
Secondary
Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
Participants assessed the overall activity of their rheumatoid arthritis (RA) on a 0 to 100 mm VAS, where 0 mm = no disease activity and 100 mm = extreme disease activity.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.00 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 1.50 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | -1.00 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.00 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 8.00 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | -0.50 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | -0.25 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 2.50 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.50 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 12.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.25 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 0.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | -0.50 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.50 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.50 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | -0.25 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | -1.00 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 18.00 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 13.00 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | -24.00 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 10.00 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | -7.00 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 4.00 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 20.00 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | -7.50 mm |
| Placebo - Period 2 | Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | -5.50 mm |
Secondary
Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 1.90 mm | Standard Error 3.32 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | -3.05 mm | Standard Error 3.56 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 2.21 mm | Standard Error 3.61 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | -1.18 mm | Standard Error 3.88 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 3.20 mm | Standard Error 3.81 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | 2.05 mm | Standard Error 3.9 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 1.06 mm | Standard Error 4.02 |
| Etanercept 50 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 1.32 mm | Standard Error 4.06 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 12.21 mm | Standard Error 3.9 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 12.84 mm | Standard Error 4.26 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | 7.46 mm | Standard Error 4.06 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 7.13 mm | Standard Error 4.08 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | 13.00 mm | Standard Error 4.15 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 5.67 mm | Standard Error 3.69 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | 8.05 mm | Standard Error 3.84 |
| Etanercept 25 mg - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 9.13 mm | Standard Error 4.28 |
| Placebo - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 | 12.91 mm | Standard Error 12.4 |
| Placebo - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 | 34.27 mm | Standard Error 9.43 |
| Placebo - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 | 22.70 mm | Standard Error 6.39 |
| Placebo - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 | 11.32 mm | Standard Error 12.41 |
| Placebo - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 | 7.13 mm | Standard Error 14.49 |
| Placebo - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 | 1.46 mm | Standard Error 14.49 |
| Placebo - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 | 15.97 mm | Standard Error 12.41 |
| Placebo - Period 2 | Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 | 6.47 mm | Standard Error 14.5 |
Secondary
Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
PGA of disease activity was measured on a 0 to 100 millimeter (mm) Visual Analog Scale (VAS), with 0 mm = no disease activity and 100 mm = extreme disease activity.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure and 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 2.50 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.25 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 1.00 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 15, 3) | 1.00 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,22) | 4.00 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.25 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 1.00 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 14) | 1.50 mm |
| Etanercept 50 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 15, 3) | 2.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,22) | 3.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 14) | 0.25 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 0.50 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 4.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | -1.00 mm |
| Etanercept 25 mg - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | -1.75 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 6.75 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,22) | 2.25 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | -6.50 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 14) | 4.00 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | -1.50 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 15, 3) | 8.00 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 10.00 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | -3.00 mm |
| Placebo - Period 2 | Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 5.00 mm |
Secondary
Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1. A negative value in change from randomization indicates an improvement.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 swollen joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.0 swollen joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.0 swollen joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 swollen joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 0.0 swollen joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.0 swollen joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 0.0 swollen joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.0 swollen joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.0 swollen joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.0 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 1.0 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 0.0 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.0 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.0 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.5 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.0 swollen joints |
| Placebo - Period 2 | Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.0 swollen joints |
Secondary
Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. A negative value in change from randomization indicates an improvement.
Time frame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time point for each treatment arm, respectively.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 tender joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.0 tender joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.0 tender joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 tender joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 0.0 tender joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.0 tender joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 0.0 tender joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.0 tender joints |
| Etanercept 50 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | 0.0 tender joints |
| Etanercept 25 mg - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.0 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 12 (n= 18, 21, 6) | 0.5 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Randomization (n=23,27,23) | 0.0 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 36 (n= 13, 14, 2) | -0.5 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 6 (n= 22, 26, 15) | 1.0 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 48 (n= 12, 12, 2) | 0.5 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 24 (n= 14, 16, 3) | 0.0 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 18 (n= 16, 19, 3) | 0.0 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 42 (n= 12, 12, 2) | -0.5 tender joints |
| Placebo - Period 2 | Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48 | Change at Week 30 (n= 14, 15, 3) | 0.0 tender joints |
Secondary
Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PtGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 \<=3.2 implied low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity and less than (\<) 2.6=remission.
Time frame: Randomization (Week 0)
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization | 1.86 units on a scale | Standard Deviation 0.62 |
| Etanercept 25 mg - Period 2 | Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization | 1.93 units on a scale | Standard Deviation 0.85 |
| Placebo - Period 2 | Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization | 1.93 units on a scale | Standard Deviation 0.71 |
Secondary
Magnetic Resonance Imaging (MRI) Findings at Randomization
MRI of hand/wrist of dominant hand scored for signs of synovitis (S-score), bone edema(O-score), bone erosions (E-score) as per outcome measures in RA clinical trials (OMERACT). S-score:0(normal)-3(severe) for distal radioulnar,radiocarpal,intercarpal-carpometacarpal,second-fifth metacarpophalangeal joints, total score(TS)0-21, higher score(HS)=severe synovitis. O-score:0(no volume increment)-3(100% volume increment) in 23 hand/wrist joints, TS 0-69, HS=more edema. E-score:0(no volume occupied by erosion)-10(100% volume occupied by erosion) in 23 hand/wrist joints, TS 0-230, HS=more erosion.
Time frame: Randomization (Week 0)
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etanercept 50 mg - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | O-Score | 1.50 units on a scale | Standard Deviation 1.34 |
| Etanercept 50 mg - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | S-Score | 4.19 units on a scale | Standard Deviation 3.13 |
| Etanercept 50 mg - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | E-Score | 12.53 units on a scale | Standard Deviation 18.47 |
| Etanercept 25 mg - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | O-Score | 3.14 units on a scale | Standard Deviation 3.95 |
| Etanercept 25 mg - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | S-Score | 4.90 units on a scale | Standard Deviation 3.26 |
| Etanercept 25 mg - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | E-Score | 25.10 units on a scale | Standard Deviation 28.23 |
| Placebo - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | S-Score | 4.37 units on a scale | Standard Deviation 4.43 |
| Placebo - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | E-Score | 12.60 units on a scale | Standard Deviation 10.8 |
| Placebo - Period 2 | Magnetic Resonance Imaging (MRI) Findings at Randomization | O-Score | 3.63 units on a scale | Standard Deviation 3.36 |
Secondary
Participant General Health Visual Analog Scale (VAS) at Randomization
Participants answered in general how would you rate your health over the last 2-3 weeks? Participants responded by using a 0 to 100 mm VAS, where 0 mm = very well and 100 mm = extremely bad.
Time frame: Randomization (Week 0)
Population: m-ITT analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Participant General Health Visual Analog Scale (VAS) at Randomization | 14.43 mm | Standard Deviation 12.87 |
| Etanercept 25 mg - Period 2 | Participant General Health Visual Analog Scale (VAS) at Randomization | 15.11 mm | Standard Deviation 13.15 |
| Placebo - Period 2 | Participant General Health Visual Analog Scale (VAS) at Randomization | 18.52 mm | Standard Deviation 15.35 |
Secondary
Participant Pain Visual Analog Scale (VAS) at Randomization
Participants indicated the amount of pain experience during the last 2-3 days by marking a vertical line on 100 mm VAS. Intensity of pain range: 0 = no pain to 100 = pain as bad as it could be.
Time frame: Randomization (Week 0)
Population: m-ITT analysis set.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Participant Pain Visual Analog Scale (VAS) at Randomization | 15.59 mm | Standard Deviation 18.16 |
| Etanercept 25 mg - Period 2 | Participant Pain Visual Analog Scale (VAS) at Randomization | 12.96 mm | Standard Deviation 10.92 |
| Placebo - Period 2 | Participant Pain Visual Analog Scale (VAS) at Randomization | 13.37 mm | Standard Deviation 10.05 |
Secondary
Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
Percentage of participants who were treatment failure over 48 weeks as per potentially predictor variables (at randomization) are reported: number of swollen joints/tender joints, DAS28, PGA, PtGA, participant general health VAS, participant pain VAS, clinical disease activity index (CDAI), simplified disease activity index (SDAI), ESR (mm/hour), plasma CRP (mg/L), sensitive serum CRP (mg/L), anti- cyclic citrullinated peptide (anti CCP, units/mL), cartilage oligomeric matrix protein (COMP, units/liter), S-score, O-score, E-score, Joint space narrowing score, erosion score, and mTSS.
Time frame: Randomization (Week 0) up to Week 48
Population: m-ITT analysis set.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS>14 to 26.5(n=2,7,7) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of swollen joints >0 (n= 5, 6, 4) | 60.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints = 0 (n= 20, 19, 15) | 45.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints >0 to 1 (n= 2, 4, 6) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints > 1 (n= 0, 4, 2) | 0.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 <=2.6 (n= 20, 21, 18) | 40.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 >2.6 to 3.2 (n= 2, 5, 5) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 >3.2 to 5.1 (n= 0, 1, 0) | 0.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA = 0 (n= 6, 4, 9) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >0 to 3 (n= 5, 10, 3) | 60.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >3 to 7 (n= 9, 5, 5) | 33.3 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >7 (n= 3, 8, 5) | 66.7 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA <= 2.5 (n= 6, 8, 5) | 66.7 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >2.5 to 11 (n= 7, 5, 6) | 28.6 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >11 to 21 (n= 4, 7, 7) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >21 (n= 6, 7, 5) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS <=3 (n= 6, 7, 6) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS >3 to 14 (n= 9,8,4) | 44.4 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of swollen joints = 0 (n= 18, 21, 19) | 44.4 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS >26.5 (n= 6, 5, 6) | 33.3 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS <=3 (n= 7, 8, 5) | 57.1 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >3 to 10 (n= 6, 5, 6) | 33.3 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >10 to 22 (n=3, 7, 8) | 33.3 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >22 (n= 7, 7, 4) | 57.1 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | CDAI <= 2.8 (n= 14, 13, 13) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | CDAI >2.8 to 10 (n= 9, 14, 9) | 44.4 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI<= 3.3 (n= 8, 7, 8) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>3.3 to 11 (n= 13, 15, 12) | 38.5 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>11 to 26 (n= 2, 4, 2) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>26 (n= 0, 1, 0) | 0.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR<= 5 (n= 6, 8, 10) | 66.7 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >5 to 10 (n= 7, 9, 6) | 28.6 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >10 to 12.5 (n= 0, 3, 2) | 0.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >12.5 (n= 6, 7, 5) | 66.7 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP <= 1 (n= 8, 8, 8) | 62.5 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >1 to 2 (n= 5, 2, 7) | 20.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >2 to 5 (n= 6, 11, 3) | 16.7 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >5 (n= 4, 6, 5) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP <= 0.6 (n= 7, 5, 6) | 57.1 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >0.6 to 1.2 (n= 5, 5, 7) | 40.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >1.2 to 3.3 (n= 6, 7, 5) | 33.3 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >3.3 (n= 4, 8, 5) | 75.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP <= 31.7 (n= 5, 8, 5) | 40.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >31.7 to 346.8 (n= 8, 3, 6) | 75.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >346.8 to 710.8 (n= 5, 4, 9) | 20.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >710.8 (n= 4, 10, 3) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP <= 7.6 (n= 7, 5, 6) | 28.6 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >7.6 to 9.6 (n= 5, 4, 8) | 60.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >9.6 to 12.3 (n= 5, 11, 2) | 80.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >12.3 (n= 5, 5, 7) | 40.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score <= 1.5 (n= 5, 5, 5) | 20.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >1.5 to 3.8 (n= 5, 2, 5) | 20.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >3.8 to 7.5 (n= 5, 8, 1) | 80.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >7.5 (n= 3, 6, 4) | 66.7 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score <= 0.5 (n= 6, 7, 4) | 16.7 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >0.5 to 1.5 (n= 4, 6, 2) | 25.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >1.5 to 3.5 (n= 7, 0, 3) | 71.4 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >3.5 (n= 1, 6, 6) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score <= 3.0 (n= 7, 5, 5) | 14.3 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >3.0 to 9.8 (n= 4, 4, 2) | 75.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >9.8 to 23.0 (n= 5, 4, 5) | 60.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >23.0 (n= 2, 8, 3) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score <= 0.5 (n= 5, 7, 5) | 20.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >0.5 to 9.0 (n=5,0,6) | 60.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >9.0 to 23.5 (n=7,4,3) | 57.1 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >23.5 (n= 2, 9, 3) | 50.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score <= 9.0 (n= 7, 0, 3) | 42.9 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >9.0 to 21.3 (n= 4, 3, 7) | 25.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >21.3 to 47.5 (n= 5, 6, 4) | 40.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >47.5 (n= 3, 8, 3) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS <= 10.0 (n= 5, 6, 4) | 20.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >10.0 to 31.5 (n= 5, 3, 6) | 60.0 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >31.5 to 70.0 (n= 7, 4, 4) | 42.9 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >70.0 (n= 2, 9, 3) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | CDAI <= 2.8 (n= 14, 13, 13) | 46.2 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | CDAI >2.8 to 10 (n= 9, 14, 9) | 64.3 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI<= 3.3 (n= 8, 7, 8) | 28.6 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score <= 3.0 (n= 7, 5, 5) | 20.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>3.3 to 11 (n= 13, 15, 12) | 60.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>11 to 26 (n= 2, 4, 2) | 75.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >31.5 to 70.0 (n= 7, 4, 4) | 75.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>26 (n= 0, 1, 0) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >3.0 to 9.8 (n= 4, 4, 2) | 25.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR<= 5 (n= 6, 8, 10) | 12.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >5 to 10 (n= 7, 9, 6) | 66.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >47.5 (n= 3, 8, 3) | 75.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >10 to 12.5 (n= 0, 3, 2) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >9.8 to 23.0 (n= 5, 4, 5) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >12.5 (n= 6, 7, 5) | 71.4 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP <= 1 (n= 8, 8, 8) | 37.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >1 to 2 (n= 5, 2, 7) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >23.0 (n= 2, 8, 3) | 62.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >2 to 5 (n= 6, 11, 3) | 54.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >5 (n= 4, 6, 5) | 83.3 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP <= 0.6 (n= 7, 5, 6) | 20.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score <= 0.5 (n= 5, 7, 5) | 28.6 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >0.6 to 1.2 (n= 5, 5, 7) | 80.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >1.2 to 3.3 (n= 6, 7, 5) | 42.9 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS <= 10.0 (n= 5, 6, 4) | 16.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >3.3 (n= 4, 8, 5) | 75.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >0.5 to 9.0 (n=5,0,6) | 0.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP <= 31.7 (n= 5, 8, 5) | 37.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >31.7 to 346.8 (n= 8, 3, 6) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >346.8 to 710.8 (n= 5, 4, 9) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >9.0 to 23.5 (n=7,4,3) | 75.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >710.8 (n= 4, 10, 3) | 60.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP <= 7.6 (n= 7, 5, 6) | 20.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >7.6 to 9.6 (n= 5, 4, 8) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >23.5 (n= 2, 9, 3) | 66.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >9.6 to 12.3 (n= 5, 11, 2) | 63.6 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >12.3 (n= 5, 5, 7) | 80.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of swollen joints = 0 (n= 18, 21, 19) | 57.1 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of swollen joints >0 (n= 5, 6, 4) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >10.0 to 31.5 (n= 5, 3, 6) | 33.3 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints = 0 (n= 20, 19, 15) | 47.4 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score <= 1.5 (n= 5, 5, 5) | 40.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints >0 to 1 (n= 2, 4, 6) | 75.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints > 1 (n= 0, 4, 2) | 75.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score <= 9.0 (n= 7, 0, 3) | 0.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 <=2.6 (n= 20, 21, 18) | 47.6 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >1.5 to 3.8 (n= 5, 2, 5) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 >2.6 to 3.2 (n= 2, 5, 5) | 80.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 >3.2 to 5.1 (n= 0, 1, 0) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA = 0 (n= 6, 4, 9) | 25.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >3.8 to 7.5 (n= 5, 8, 1) | 37.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >0 to 3 (n= 5, 10, 3) | 60.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >3 to 7 (n= 9, 5, 5) | 40.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >7 (n= 3, 8, 5) | 75.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >7.5 (n= 3, 6, 4) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA <= 2.5 (n= 6, 8, 5) | 37.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >2.5 to 11 (n= 7, 5, 6) | 60.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >9.0 to 21.3 (n= 4, 3, 7) | 66.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >11 to 21 (n= 4, 7, 7) | 57.1 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score <= 0.5 (n= 6, 7, 4) | 42.9 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >21 (n= 6, 7, 5) | 71.4 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS <=3 (n= 6, 7, 6) | 28.6 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS >3 to 14 (n= 9,8,4) | 62.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >0.5 to 1.5 (n= 4, 6, 2) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS>14 to 26.5(n=2,7,7) | 57.1 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS >26.5 (n= 6, 5, 6) | 80.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >70.0 (n= 2, 9, 3) | 66.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS <=3 (n= 7, 8, 5) | 37.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >1.5 to 3.5 (n= 7, 0, 3) | 0.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >3 to 10 (n= 6, 5, 6) | 20.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >10 to 22 (n=3, 7, 8) | 85.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >21.3 to 47.5 (n= 5, 6, 4) | 50.0 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >22 (n= 7, 7, 4) | 71.4 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >3.5 (n= 1, 6, 6) | 50.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >10 to 22 (n=3, 7, 8) | 87.5 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >3.5 (n= 1, 6, 6) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >22 (n= 7, 7, 4) | 75.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | CDAI >2.8 to 10 (n= 9, 14, 9) | 88.9 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >21.3 to 47.5 (n= 5, 6, 4) | 75.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of swollen joints = 0 (n= 18, 21, 19) | 84.2 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI<= 3.3 (n= 8, 7, 8) | 75.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >12.3 (n= 5, 5, 7) | 85.7 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA <= 2.5 (n= 6, 8, 5) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>3.3 to 11 (n= 13, 15, 12) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score <= 3.0 (n= 7, 5, 5) | 60.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of swollen joints >0 (n= 5, 6, 4) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>11 to 26 (n= 2, 4, 2) | 50.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >7.5 (n= 3, 6, 4) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS>14 to 26.5(n=2,7,7) | 71.4 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | SDAI>26 (n= 0, 1, 0) | 0.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints = 0 (n= 20, 19, 15) | 86.7 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >2.5 to 11 (n= 7, 5, 6) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR<= 5 (n= 6, 8, 10) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >3.0 to 9.8 (n= 4, 4, 2) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >0.5 to 1.5 (n= 4, 6, 2) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >5 to 10 (n= 7, 9, 6) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints >0 to 1 (n= 2, 4, 6) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score <= 1.5 (n= 5, 5, 5) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >10 to 12.5 (n= 0, 3, 2) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS >3 to 10 (n= 6, 5, 6) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Number of tender joints > 1 (n= 0, 4, 2) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | ESR >12.5 (n= 6, 7, 5) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >9.8 to 23.0 (n= 5, 4, 5) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >11 to 21 (n= 4, 7, 7) | 85.7 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP <= 1 (n= 8, 8, 8) | 75.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >47.5 (n= 3, 8, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS >26.5 (n= 6, 5, 6) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >1 to 2 (n= 5, 2, 7) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 <=2.6 (n= 20, 21, 18) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score >1.5 to 3.5 (n= 7, 0, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >2 to 5 (n= 6, 11, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | E-score >23.0 (n= 2, 8, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PtGA >21 (n= 6, 7, 5) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Plasma CRP >5 (n= 4, 6, 5) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >31.5 to 70.0 (n= 7, 4, 4) | 75.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 >2.6 to 3.2 (n= 2, 5, 5) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP <= 0.6 (n= 7, 5, 6) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >1.5 to 3.8 (n= 5, 2, 5) | 60.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | O-score <= 0.5 (n= 6, 7, 4) | 50.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >0.6 to 1.2 (n= 5, 5, 7) | 85.7 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score <= 0.5 (n= 5, 7, 5) | 60.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | DAS28 >3.2 to 5.1 (n= 0, 1, 0) | 0.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >1.2 to 3.3 (n= 6, 7, 5) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score <= 9.0 (n= 7, 0, 3) | 66.7 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | CDAI <= 2.8 (n= 14, 13, 13) | 84.6 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Sensitive serum CRP >3.3 (n= 4, 8, 5) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA = 0 (n= 6, 4, 9) | 88.9 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS <=3 (n= 6, 7, 6) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP <= 31.7 (n= 5, 8, 5) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >0.5 to 9.0 (n=5,0,6) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Erosion score >9.0 to 21.3 (n= 4, 3, 7) | 85.7 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >31.7 to 346.8 (n= 8, 3, 6) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS <= 10.0 (n= 5, 6, 4) | 50.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >0 to 3 (n= 5, 10, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >346.8 to 710.8 (n= 5, 4, 9) | 77.8 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | S-score >3.8 to 7.5 (n= 5, 8, 1) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant pain VAS <=3 (n= 7, 8, 5) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Anti-CCP >710.8 (n= 4, 10, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >9.0 to 23.5 (n=7,4,3) | 66.7 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >3 to 7 (n= 9, 5, 5) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP <= 7.6 (n= 7, 5, 6) | 66.7 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >70.0 (n= 2, 9, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | mTSS >10.0 to 31.5 (n= 5, 3, 6) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >7.6 to 9.6 (n= 5, 4, 8) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Participant general health VAS >3 to 14 (n= 9,8,4) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | PGA >7 (n= 3, 8, 5) | 80.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | COMP >9.6 to 12.3 (n= 5, 11, 2) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization | Joint space narrowing score >23.5 (n= 2, 9, 3) | 100 percentage of participants |
Secondary
Percentage of Participants With Remission or Low Disease Activity (LDA)
Participants who had DAS28 less than or equal to (\<=) 3.2 were considered in remission or LDA state.
Time frame: Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
Population: m-ITT analysis set. Here, 'n' signifies participants evaluable for each time-point for each treatment arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 6 (n= 21, 26, 15) | 90.5 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 30 (n= 14, 15, 3) | 92.9 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Randomization (n= 22, 27, 23) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 12 (n= 18, 21, 6) | 94.4 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 48 (n= 12, 12, 2) | 83.3 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 36 (n= 13, 14, 2) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 18 (n= 16, 19, 3) | 87.5 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Baseline (n= 19, 23, 19) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week -4 (n= 23, 26, 23) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 24 (n= 14, 16, 3) | 100 percentage of participants |
| Etanercept 50 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 42 (n= 12, 12, 2) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 24 (n= 14, 16, 3) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 30 (n= 14, 15, 3) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 36 (n= 13, 14, 2) | 85.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 42 (n= 12, 12, 2) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 48 (n= 12, 12, 2) | 91.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Randomization (n= 22, 27, 23) | 96.3 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 6 (n= 21, 26, 15) | 80.8 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Baseline (n= 19, 23, 19) | 100 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 12 (n= 18, 21, 6) | 85.7 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 18 (n= 16, 19, 3) | 89.5 percentage of participants |
| Etanercept 25 mg - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week -4 (n= 23, 26, 23) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 48 (n= 12, 12, 2) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Randomization (n= 22, 27, 23) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Baseline (n= 19, 23, 19) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week -4 (n= 23, 26, 23) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 6 (n= 21, 26, 15) | 60.0 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 12 (n= 18, 21, 6) | 83.3 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 18 (n= 16, 19, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 24 (n= 14, 16, 3) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 36 (n= 13, 14, 2) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 42 (n= 12, 12, 2) | 100 percentage of participants |
| Placebo - Period 2 | Percentage of Participants With Remission or Low Disease Activity (LDA) | Week 30 (n= 14, 15, 3) | 66.7 percentage of participants |
Secondary
Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State
Participants who had DAS28 \<=3.2 were considered in remission or LDA state. Percentage of visits during which a participant was in remission or LDA state was calculated as number of visits in which participant was in remission or LDA divided by total number of visits multiplied by 100.
Time frame: Randomization (Week 0) up to Week 48
Population: m-ITT analysis set. Here, N (number of participants analyzed) signifies participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept 50 mg - Period 2 | Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State | 82.7 percentage of visits | Standard Deviation 31.1 |
| Etanercept 25 mg - Period 2 | Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State | 74.8 percentage of visits | Standard Deviation 38 |
| Placebo - Period 2 | Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State | 55.3 percentage of visits | Standard Deviation 48.5 |
Secondary
Time to Treatment Failure (TTF)
TTF (in weeks): (date of failure minus date of randomization) divided by 7. Date of failure was ordinary visit date or extra visit date in case of failure (extra visit was within 2 weeks from the date a participant experienced significant disease progression between visits and wanted to withdraw from Period 2), or date of withdrawal due to disease progression. Participants who did not have a treatment failure were censored at their last evaluation visit. Participants who withdrew from the study prematurely and did not have a treatment failure were censored on the date of their withdrawal.
Time frame: Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)
Population: m-ITT analysis set.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Etanercept 50 mg - Period 2 | Time to Treatment Failure (TTF) | 48.0 weeks |
| Etanercept 25 mg - Period 2 | Time to Treatment Failure (TTF) | 36.1 weeks |
| Placebo - Period 2 | Time to Treatment Failure (TTF) | 6.1 weeks |