Rheumatoid Arthritis
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy of etanercept monotherapy compared to methotrexate monotherapy on maintenance of remission in participants with rheumatoid arthritis (RA) who were on etanercept plus methotrexate therapy. This is a multicenter, randomized withdrawal, double-blind controlled study in participants with rheumatoid arthritis on etanercept plus methotrexate therapy who are in very good disease control for 6 months prior to study entry. The study will consist of a 30-day screening period, a 24-week open label run-in period, a 48-week double-blind treatment period and a 30-day safety follow-up period.
Interventions
DRUGetanercept pre-filled syringe subcutaneous injection
etanercept for injection in pre-filled syringes
DRUGOral methotrexate
During the open-label run-in period, methotrexate will be provided as 2.5 mg tablets. During the double-blind treatment period, methotrexate will be provided as 2.5 mg capsules.
DRUGPlacebo for etanercept subcutaneous injection
etanercept placebo for injection in pre-filled syringes
DRUGPlacebo for methotrexate
methotrexate placebo capsules
DIETARY_SUPPLEMENTFolic acid (non-investigational product)
Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.
Sponsors
Amgen
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
(Part 1, Run-In Period): * Subjects must be adults with a history of moderate to severe rheumatoid arthritis; * Subjects must be in very good rheumatoid arthritis disease control for ≥ 6 months and be in remission as defined by a Simplified Disease Activity Index ≤ 3.3 at screening and at the end of the run-in period. * Subjects must be on etanercept 50 mg per week plus methotrexate therapy for ≥ 6 months prior to the start of the run-in period. The methotrexate dose must be 10 to 25 mg per week for ≥ 6 months prior to the start of the run-in period and the dose must be stable for ≥ 8 weeks prior to the start of the run-in period. * Subject has no known history of active tuberculosis, and has a negative test for tuberculosis during screening.
Exclusion criteria
(Part 1, Run-In Period): * Subject has used biologic disease modifying antirheumatic drug other than etanercept OR has used an oral janus kinase inhibitor ≤ 6 months prior to run-in visit 1 * Subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to run-in visit 1. * Subject has known alcohol addiction or dependency or uses alcohol daily. * Subject has one or more significant concurrent medical conditions per investigator judgment, including the following: * poorly controlled diabetes * chronic kidney disease stage IIIb, IV, or V * symptomatic heart failure (New York Heart Association class II, III, or IV) * myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization * uncontrolled hypertension * severe chronic pulmonary disease (eg, requiring oxygen therapy) * multiple sclerosis or any other demyelinating disease * major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus with the exception of secondary Sjögren's syndrome) Inclusion Criteria (Part 2, Treatment Period): * SDAI ≤ 3.3 at run-in visit 3 * Subject if female and not at least 2 years postmenopausal or history of hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, has a negative urine pregnancy test at baseline (day 1).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy | Week 48 | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SDAI Score at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. |
| Change From Baseline in SDAI Score at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. A negative change from baseline indicates improvement. |
| Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. |
| Change From Baseline in DAS28-ESR at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement. |
| Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. |
| Change From Baseline in DAS28-CRP at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement. |
| Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. |
| Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy | Week 48 | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. |
| Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. |
| Percentage of Participants With Boolean Remission at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | A participant achieves Boolean remission (66/68-joint count) if all of the following criteria are met at a single timepoint: * 68-joint tender joint count ≤ 1 * 66-joint swollen joint count ≤ 1 * CRP (mg/dL) ≤ 1 * Patient's Global Assessment of Disease Activity using a VAS (where 0=no arthritis activity at all and 10=worst arthritis activity imaginable) ≤ 1. |
| Percentage of Participants With Disease Worsening | Baseline, Week 12, Week 24, Week 36 and Week 48 | Percentage of participants who fulfilled disease-worsening criteria for the first time is presented. Disease worsening is defined as any of the following: * an SDAI \> 3.3 and ≤ 11 during 2 consecutive visits at least 2 weeks apart * SDAI \> 3.3 and ≤ 11 on 3 or more separate visits * SDAI \> 11 after randomization. The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. |
| Time to Disease Worsening | up to Week 48 | Disease worsening is defined as any of the following: * an SDAI \> 3.3 and ≤ 11 during 2 consecutive visits at least 2 weeks apart * SDAI \> 3.3 and ≤ 11 on 3 or more separate visits * SDAI \> 11 after randomization. The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. |
| Time to Recapture SDAI Remission After Starting Rescue Treatment | Between rescue and remission or Week 48, whichever comes first. | In participants who receive rescue treatment during the double-blind treatment period. The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. |
| Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48 | Week 48 | The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. |
| Change From Baseline in CDAI at All Measured Timepoints | Baseline, Week 12, Week 24, Week 36 and Week 48 | The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. A negative change from baseline indicates improvement. |
Countries
Argentina, Bulgaria, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Mexico, Poland, Portugal, South Africa, Spain, United States
Participant flow
Recruitment details
This study was conducted at 97 centers in Canada, United States, Argentina, Bulgaria, Czech Republic, Spain, France, Germany, Greece, Hungary, Italy, Mexico, Poland, Portugal, and South Africa. The first participant enrolled on 20 February 2015; the last participant enrolled on 26 June 2018.
Pre-assignment details
After a 24-week open label run-in period, participants were randomly assigned in a 2:2:1 ratio to one of three treatment groups: methotrexate monotherapy, etanercept monotherapy, or etanercept plus methotrexate.
Participants by arm
| Arm | Count |
|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy Oral methotrexate 10 to 25 mg weekly plus placebo for etanercept for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). | 101 |
| Double-Blind Treatment: Etanercept Monotherapy Etanercept 50 mg weekly by subcutaneous injection plus placebo to methotrexate for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening initiated rescue treatment with etanercept 50 mg QW plus methotrexate (10 to 25 mg). | 101 |
| Double-Blind Treatment: Etanercept Plus Methotrexate Etanercept 50 mg weekly by subcutaneous injection plus oral methotrexate 10 to 25 mg weekly for 48 weeks. Participants also receive folic acid as standard of care.
After randomization, a participant experiencing protocol-defined disease worsening continued on the assigned treatments (as rescue treatment). | 51 |
| Total | 253 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Double-Blind Treatment Period | Decision by Sponsor | 0 | 1 | 2 | 0 |
| Double-Blind Treatment Period | Lost to Follow-up | 0 | 0 | 1 | 1 |
| Double-Blind Treatment Period | Protocol Violation | 0 | 2 | 0 | 0 |
| Double-Blind Treatment Period | Withdrawal by Subject | 0 | 10 | 6 | 3 |
| Run-In Period | Adverse Event | 3 | 0 | 0 | 0 |
| Run-In Period | Decision by Sponsor | 11 | 0 | 0 | 0 |
| Run-In Period | Ineligibility Determined | 3 | 0 | 0 | 0 |
| Run-In Period | Lost to Follow-up | 2 | 0 | 0 | 0 |
| Run-In Period | Noncompliance | 1 | 0 | 0 | 0 |
| Run-In Period | Other, Not Specified | 5 | 0 | 0 | 0 |
| Run-In Period | Protocol Violation | 75 | 0 | 0 | 0 |
| Run-In Period | Withdrawal by Subject | 16 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Double-Blind Treatment: Methotrexate Monotherapy | Double-Blind Treatment: Etanercept Monotherapy | Double-Blind Treatment: Etanercept Plus Methotrexate | Total |
|---|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 11.4 | 54.8 years STANDARD_DEVIATION 12.8 | 55.9 years STANDARD_DEVIATION 12.6 | 55.6 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 19 Participants | 8 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 82 Participants | 43 Participants | 213 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participants | 3 Participants | 2 Participants | 9 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 7 Participants | 5 Participants | 15 Participants |
| Race/Ethnicity, Customized Other, Not Specified | 0 Participants | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 92 Participants | 86 Participants | 42 Participants | 220 Participants |
| Sex: Female, Male Female | 76 Participants | 77 Participants | 40 Participants | 193 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 11 Participants | 60 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 | 0 / 368 | 0 / 100 | 0 / 99 | 0 / 53 | 0 / 103 |
| other Total, other adverse events | 29 / 368 | 21 / 100 | 12 / 99 | 8 / 53 | 9 / 103 |
| serious Total, serious adverse events | 14 / 368 | 3 / 100 | 3 / 99 | 2 / 53 | 4 / 103 |
Outcome results
Primary
Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
Time frame: Week 48
Population: Primary Analysis Set: all randomized participants. Nonresponder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy | 28.7 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission (≤ 3.3) at Week 48: Etanercept Monotherapy vs. Methotrexate Monotherapy | 49.5 percentage of participants |
p-value: 0.00495% CI: [7.6, 33.9]Chi-squared, Corrected
Secondary
Change From Baseline in CDAI at All Measured Timepoints
The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 48 | 2.17 score on a scale | Standard Error 0.37 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 24 | 4.09 score on a scale | Standard Error 0.95 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 36 | 2.69 score on a scale | Standard Error 0.63 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 12 | 5.39 score on a scale | Standard Error 0.97 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 48 | 1.15 score on a scale | Standard Error 0.23 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 12 | 3.15 score on a scale | Standard Error 0.73 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 36 | 1.07 score on a scale | Standard Error 0.37 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 24 | 3.75 score on a scale | Standard Error 0.9 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 24 | 1.70 score on a scale | Standard Error 0.61 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 36 | 1.41 score on a scale | Standard Error 0.4 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 12 | 3.24 score on a scale | Standard Error 1.17 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in CDAI at All Measured Timepoints | Change at Week 48 | 2.00 score on a scale | Standard Error 0.92 |
Comparison: Change at Week 12p-value: 0.1895% CI: [-5.29, 1]two sample t-test
Comparison: Change at Week 12p-value: 0.06795% CI: [-4.63, 0.16]two sample t-test
Comparison: Change at Week 24p-value: 0.03595% CI: [-4.62, -0.17]two sample t-test
Comparison: Change at Week 24p-value: 0.7995% CI: [-2.91, 2.23]two sample t-test
Comparison: Change at Week 36p-value: 0.0995% CI: [-2.75, 0.2]two sample t-test
Comparison: Change at Week 36p-value: 0.02995% CI: [-3.06, -0.17]two sample t-test
Comparison: Change at Week 48p-value: 0.8695% CI: [-2.15, 1.81]two sample t-test
Comparison: Change at Week 48p-value: 0.02195% CI: [-1.88, -0.16]two sample t-test
Secondary
Change From Baseline in DAS28-CRP at All Measured Timepoints
The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 12 | 0.84 score on a scale | Standard Error 0.12 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 24 | 0.67 score on a scale | Standard Error 0.11 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 36 | 0.49 score on a scale | Standard Error 0.09 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 48 | 0.40 score on a scale | Standard Error 0.07 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 48 | 0.19 score on a scale | Standard Error 0.04 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 12 | 0.42 score on a scale | Standard Error 0.09 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 36 | 0.18 score on a scale | Standard Error 0.06 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 24 | 0.52 score on a scale | Standard Error 0.11 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 48 | 0.21 score on a scale | Standard Error 0.11 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 24 | 0.25 score on a scale | Standard Error 0.08 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 36 | 0.20 score on a scale | Standard Error 0.08 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in DAS28-CRP at All Measured Timepoints | Change at Week 12 | 0.41 score on a scale | Standard Error 0.15 |
Comparison: Change at Week 12p-value: 0.0395% CI: [-0.82, -0.04]two sample t-test
Comparison: Change at Week 12p-value: 0.00595% CI: [-0.72, -0.13]two sample t-test
Comparison: Change at Week 24p-value: 0.00295% CI: [-0.69, -0.15]two sample t-test
Comparison: Change at Week 24p-value: 0.3495% CI: [-0.46, 0.16]two sample t-test
Comparison: Change at Week 36p-value: 0.01495% CI: [-0.52, -0.06]two sample t-test
Comparison: Change at Week 36p-value: 0.00495% CI: [-0.51, -0.1]two sample t-test
Comparison: Change at Week 48p-value: 0.1295% CI: [-0.43, 0.05]two sample t-test
Comparison: Change at Week 48p-value: 0.0195% CI: [-0.37, -0.05]two sample t-test
Secondary
Change From Baseline in DAS28-ESR at All Measured Timepoints
The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 12 | 0.96 score on a scale | Standard Error 0.13 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 24 | 0.65 score on a scale | Standard Error 0.12 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 36 | 0.53 score on a scale | Standard Error 0.1 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 48 | 0.43 score on a scale | Standard Error 0.09 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 48 | 0.34 score on a scale | Standard Error 0.07 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 12 | 0.50 score on a scale | Standard Error 0.1 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 36 | 0.31 score on a scale | Standard Error 0.08 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 24 | 0.69 score on a scale | Standard Error 0.13 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 48 | 0.32 score on a scale | Standard Error 0.14 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 24 | 0.34 score on a scale | Standard Error 0.11 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 36 | 0.35 score on a scale | Standard Error 0.12 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in DAS28-ESR at All Measured Timepoints | Change at Week 12 | 0.48 score on a scale | Standard Error 0.18 |
Comparison: Change at Week 12p-value: 0.03295% CI: [-0.91, -0.04]two sample t-test
Comparison: Change at Week 12p-value: 0.00595% CI: [-0.78, -0.15]two sample t-test
Comparison: Change at Week 24p-value: 0.05895% CI: [-0.63, 0.01]two sample t-test
Comparison: Change at Week 24p-value: 0.7895% CI: [-0.29, 0.38]two sample t-test
Comparison: Change at Week 36p-value: 0.2795% CI: [-0.49, 0.14]two sample t-test
Comparison: Change at Week 36p-value: 0.07895% CI: [-0.47, 0.03]two sample t-test
Comparison: Week 48p-value: 0.4795% CI: [-0.43, 0.2]two sample t-test
Comparison: Change at Week 48p-value: 0.3995% CI: [-0.33, 0.13]two sample t-test
Secondary
Change From Baseline in SDAI Score at All Measured Timepoints
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3. A negative change from baseline indicates improvement.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 48 | 2.27 score on a scale | Standard Error 0.39 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 24 | 4.42 score on a scale | Standard Error 0.98 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 36 | 2.90 score on a scale | Standard Error 0.63 |
| Double-Blind Treatment: Methotrexate Monotherapy | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 12 | 5.67 score on a scale | Standard Error 1 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 24 | 3.78 score on a scale | Standard Error 0.91 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 12 | 3.14 score on a scale | Standard Error 0.75 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 36 | 1.06 score on a scale | Standard Error 0.38 |
| Double-Blind Treatment: Etanercept Monotherapy | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 48 | 1.16 score on a scale | Standard Error 0.24 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 48 | 1.77 score on a scale | Standard Error 0.94 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 36 | 1.30 score on a scale | Standard Error 0.43 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 24 | 2.14 score on a scale | Standard Error 0.78 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Change From Baseline in SDAI Score at All Measured Timepoints | Change at Week 12 | 3.21 score on a scale | Standard Error 1.19 |
Comparison: Change at Week 12p-value: 0.1395% CI: [-5.68, 0.77]two sample t-test
Comparison: Change at Week 12p-value: 0.04595% CI: [-4.99, -0.06]two sample t-test
Comparison: Change at Week 24p-value: 0.07195% CI: [-4.75, 0.2]two sample t-test
Comparison: Change at Week 24p-value: 0.6395% CI: [-3.28, 2]two sample t-test
Comparison: Change at Week 36p-value: 0.03795% CI: [-3.11, -0.1]two sample t-test
Comparison: Change at Week 36p-value: 0.01395% CI: [-3.3, -0.39]two sample t-test
Comparison: Change at Week 48p-value: 0.6295% CI: [-2.54, 1.53]two sample t-test
Comparison: Change at Week 48p-value: 0.01595% CI: [-2.02, -0.22]two sample t-test
Secondary
Clinical Disease Activity Index (CDAI) at All Measured Timepoints
The CDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, and Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable. The CDAI score ranges from 0 to 76, where a higher score represents worse disease.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 36 | 3.60 score on a scale | Standard Error 0.63 |
| Double-Blind Treatment: Methotrexate Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 12 | 6.42 score on a scale | Standard Error 0.98 |
| Double-Blind Treatment: Methotrexate Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 48 | 3.06 score on a scale | Standard Error 0.38 |
| Double-Blind Treatment: Methotrexate Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Baseline | 1.01 score on a scale | Standard Error 0.1 |
| Double-Blind Treatment: Methotrexate Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 24 | 5.07 score on a scale | Standard Error 0.95 |
| Double-Blind Treatment: Etanercept Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 12 | 4.08 score on a scale | Standard Error 0.74 |
| Double-Blind Treatment: Etanercept Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 24 | 4.63 score on a scale | Standard Error 0.91 |
| Double-Blind Treatment: Etanercept Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 36 | 1.93 score on a scale | Standard Error 0.36 |
| Double-Blind Treatment: Etanercept Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 48 | 2.00 score on a scale | Standard Error 0.23 |
| Double-Blind Treatment: Etanercept Monotherapy | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Baseline | 0.92 score on a scale | Standard Error 0.13 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 48 | 2.61 score on a scale | Standard Error 0.91 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 12 | 3.95 score on a scale | Standard Error 1.2 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Baseline | 0.71 score on a scale | Standard Error 0.12 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 36 | 2.04 score on a scale | Standard Error 0.41 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Clinical Disease Activity Index (CDAI) at All Measured Timepoints | Week 24 | 2.35 score on a scale | Standard Error 0.6 |
Comparison: Baselinep-value: 0.06795% CI: [-0.62, 0.02]two sample t-test
Comparison: Baselinep-value: 0.5995% CI: [-0.41, 0.23]two sample t-test
Comparison: Week 12p-value: 0.1395% CI: [-5.66, 0.74]two sample t-test
Comparison: Week 12p-value: 0.05995% CI: [-4.76, 0.09]two sample t-test
Comparison: Week 24p-value: 0.01795% CI: [-4.95, -0.5]two sample t-test
Comparison: Week 24p-value: 0.7495% CI: [-3.04, 2.15]two sample t-test
Comparison: Week 36p-value: 0.03995% CI: [-3.03, -0.08]two sample t-test
Comparison: Week 36p-value: 0.02395% CI: [-3.1, -0.23]two sample t-test
Comparison: Week 48p-value: 0.6595% CI: [-2.43, 1.52]two sample t-test
Comparison: Week 48p-value: 0.01795% CI: [-1.94, -0.19]two sample t-test
Secondary
Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints
The DAS28-ESR is a modified composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, ESR in mm/hr, and a 100 mm VAS measuring the participant's general health, from 0 (best) to 100 (worst). DAS28-ESR scores range from 0 to 9.4, where higher scores represent higher disease activity.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 48 | 2.22 score on a scale | Standard Error 0.1 |
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 12 | 2.78 score on a scale | Standard Error 0.14 |
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 36 | 2.32 score on a scale | Standard Error 0.11 |
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 24 | 2.41 score on a scale | Standard Error 0.13 |
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Baseline | 1.80 score on a scale | Standard Error 0.06 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 48 | 2.21 score on a scale | Standard Error 0.08 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 12 | 2.37 score on a scale | Standard Error 0.12 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 24 | 2.54 score on a scale | Standard Error 0.14 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Baseline | 1.88 score on a scale | Standard Error 0.07 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 36 | 2.17 score on a scale | Standard Error 0.08 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 12 | 2.32 score on a scale | Standard Error 0.16 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 48 | 2.11 score on a scale | Standard Error 0.13 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 36 | 2.16 score on a scale | Standard Error 0.12 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Baseline | 1.84 score on a scale | Standard Error 0.09 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Calculated Using the Erythrocyte Sedimentation Rate Formula (DAS28-ESR) at All Measured Timepoints | Week 24 | 2.17 score on a scale | Standard Error 0.12 |
Comparison: Baselinep-value: 0.7595% CI: [-0.19, 0.26]two sample t-test
Comparison: Baselinep-value: 0.4395% CI: [-0.11, 0.27]two sample t-test
Comparison: Week 12p-value: 0.04995% CI: [-0.91, 0]two sample t-test
Comparison: Week 12p-value: 0.03295% CI: [-0.77, -0.04]two sample t-test
Comparison: Week 24p-value: 0.1895% CI: [-0.58, 0.11]two sample t-test
Comparison: Week 24p-value: 0.4895% CI: [-0.24, 0.51]two sample t-test
Comparison: Week 36p-value: 0.3595% CI: [-0.51, 0.18]two sample t-test
Comparison: Week 36p-value: 0.2895% CI: [-0.41, 0.12]two sample t-test
Comparison: Week 48p-value: 0.4895% CI: [-0.44, 0.21]two sample t-test
Comparison: Week 48p-value: 0.9295% CI: [-0.26, 0.24]two sample t-test
Secondary
Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints
The DAS28-CRP is a composite index that was designed to measure disease activity using the number of tender and swollen joints based upon a 28-joint count, CRP in mg/L, and a 100 mm VAS measuring the participant's general health from 0 (best) to 100 (worst). DAS28-CRP scores range from 0 to 9.4, where higher scores represent higher disease activity.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 36 | 1.96 score on a scale | Standard Error 0.09 |
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 24 | 2.15 score on a scale | Standard Error 0.11 |
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Baseline | 1.50 score on a scale | Standard Error 0.03 |
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 12 | 2.36 score on a scale | Standard Error 0.13 |
| Double-Blind Treatment: Methotrexate Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 48 | 1.87 score on a scale | Standard Error 0.07 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 24 | 2.00 score on a scale | Standard Error 0.11 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Baseline | 1.50 score on a scale | Standard Error 0.04 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 12 | 1.91 score on a scale | Standard Error 0.09 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 36 | 1.67 score on a scale | Standard Error 0.06 |
| Double-Blind Treatment: Etanercept Monotherapy | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 48 | 1.67 score on a scale | Standard Error 0.05 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 48 | 1.72 score on a scale | Standard Error 0.11 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 36 | 1.72 score on a scale | Standard Error 0.08 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Baseline | 1.54 score on a scale | Standard Error 0.05 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 24 | 1.77 score on a scale | Standard Error 0.09 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Disease Activity Score (28 Joint) Using the C-Reactive Protein Formula (DAS28-CRP) at All Measured Timepoints | Week 12 | 1.94 score on a scale | Standard Error 0.15 |
Comparison: Baselinep-value: 0.695% CI: [-0.09, 0.15]two sample t-test
Comparison: Baselinep-value: 0.9795% CI: [-0.1, 0.1]two sample t-test
Comparison: Week 12p-value: 0.04495% CI: [-0.82, -0.01]two sample t-test
Comparison: Week 12p-value: 0.00495% CI: [-0.76, -0.14]two sample t-test
Comparison: Week 24p-value: 0.00995% CI: [-0.66, -0.1]two sample t-test
Comparison: Week 24p-value: 0.3495% CI: [-0.46, 0.16]two sample t-test
Comparison: Week 36p-value: 0.04695% CI: [-0.47, 0]two sample t-test
Comparison: Week 36p-value: 0.00695% CI: [-0.49, -0.08]two sample t-test
Comparison: Week 48p-value: 0.2595% CI: [-0.4, -0.1]two sample t-test
Comparison: Week 48p-value: 0.02195% CI: [-0.37, -0.03]two sample t-test
Secondary
Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
Time frame: Week 48
Population: Rescue Analysis Set: randomized participants who met the definition of disease-worsening and received both at least 1 dose of active rescue therapy etanercept and at least 1 dose of active rescue therapy methotrexate. Observed cases.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48 | 54.2 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48 | 55.9 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants Receiving Rescue Treatment Who Experienced SDAI Remission at Week 48 | 66.7 percentage of participants |
p-value: 0.5895% CI: [-15.2, 40.2]Chi-squared, Corrected
Secondary
Percentage of Participants With Boolean Remission at All Measured Timepoints
A participant achieves Boolean remission (66/68-joint count) if all of the following criteria are met at a single timepoint: * 68-joint tender joint count ≤ 1 * 66-joint swollen joint count ≤ 1 * CRP (mg/dL) ≤ 1 * Patient's Global Assessment of Disease Activity using a VAS (where 0=no arthritis activity at all and 10=worst arthritis activity imaginable) ≤ 1.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 36 | 14.6 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 24 | 15.2 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 48 | 20.2 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 12 | 18.0 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Baseline | 34.0 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Baseline | 34.7 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 12 | 23.0 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 24 | 16.7 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 36 | 20.4 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 48 | 13.3 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 48 | 25.5 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 36 | 27.1 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Boolean Remission at All Measured Timepoints | Baseline | 45.1 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 24 | 26.5 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Boolean Remission at All Measured Timepoints | Week 12 | 19.6 percentage of participants |
Comparison: Baselinep-value: 0.2595% CI: [-5.4, 27.6]Chi-squared, Corrected
Comparison: Baselinep-value: 195% CI: [-12.5, 13.8]Chi-squared, Corrected
Comparison: Week 12p-value: 0.9895% CI: [-11.6, 14.9]Chi-squared, Corrected
Comparison: Week 12p-value: 0.4895% CI: [-6.2, 16.2]Chi-squared, Corrected
Comparison: Week 24p-value: 0.1695% CI: [-3.1, 25.7]Chi-squared, Corrected
Comparison: Week 24p-value: 0.9495% CI: [-9, 11.9]Chi-squared, Corrected
Comparison: Week 36p-value: 0.1295% CI: [-2.1, 27]Chi-squared, Corrected
Comparison: Week 36p-value: 0.495% CI: [-5.2, 16.8]Chi-squared, Corrected
Comparison: Week 48p-value: 0.6395% CI: [-9.8, 20.4]Chi-squared, Corrected
Comparison: Week 48p-value: 0.3195% CI: [-18, 4.2]Chi-squared, Corrected
Secondary
Percentage of Participants With Disease Worsening
Percentage of participants who fulfilled disease-worsening criteria for the first time is presented. Disease worsening is defined as any of the following: * an SDAI \> 3.3 and ≤ 11 during 2 consecutive visits at least 2 weeks apart * SDAI \> 3.3 and ≤ 11 on 3 or more separate visits * SDAI \> 11 after randomization. The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Disease Worsening | Week 12 | 42.0 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Disease Worsening | Baseline | 0.0 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Disease Worsening | Week 36 | 10.1 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Disease Worsening | Week 48 | 4.8 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With Disease Worsening | Week 24 | 8.7 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Disease Worsening | Week 48 | 0.0 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Disease Worsening | Week 12 | 23.0 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Disease Worsening | Week 24 | 14.6 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Disease Worsening | Week 36 | 3.2 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With Disease Worsening | Baseline | 0.0 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Disease Worsening | Baseline | 0.0 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Disease Worsening | Week 48 | 4.3 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Disease Worsening | Week 36 | 8.3 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Disease Worsening | Week 12 | 17.6 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With Disease Worsening | Week 24 | 6.1 percentage of participants |
Secondary
Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Baseline | 96.0 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 36 | 36.1 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 24 | 38.8 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 48 | 30.5 percentage of participants |
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 12 | 50.0 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 48 | 52.1 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Baseline | 92.1 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 12 | 64.0 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 24 | 56.6 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 36 | 55.6 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 12 | 74.5 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 48 | 56.3 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 36 | 55.1 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Baseline | 96.1 percentage of participants |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Percentage of Participants With SDAI Remission (≤ 3.3) at All Measured Timepoints | Week 24 | 62.0 percentage of participants |
Comparison: Baselinep-value: 195% CI: [-6.5, 6.6]Chi-squared, Corrected
Comparison: Baselinep-value: 0.3895% CI: [-10.4, 2.6]Chi-squared, Corrected
Comparison: Week 12p-value: 0.00795% CI: [9, 40]Chi-squared, Corrected
Comparison: Week 12p-value: 0.06395% CI: [0.4, 27.6]Chi-squared, Corrected
Comparison: Week 24p-value: 0.01295% CI: [6.7, 39.8]Chi-squared, Corrected
Comparison: Week 24p-value: 0.01895% CI: [4.1, 31.5]Chi-squared, Corrected
Comparison: Week 36p-value: 0.04495% CI: [2.1, 35.9]Chi-squared, Corrected
Comparison: Week 36p-value: 0.0195% CI: [5.8, 33.2]Chi-squared, Corrected
Comparison: Week 48p-value: 0.00595% CI: [8.9, 42.5]Chi-squared, Corrected
Comparison: Week 48p-value: 0.00495% CI: [7.9, 35.2]Chi-squared, Corrected
Secondary
Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
Time frame: Week 48
Population: Primary Analysis Set: all randomized participants. Nonresponder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy | 28.7 percentage of participants |
| Double-Blind Treatment: Etanercept Monotherapy | Percentage of Participants With SDAI Remission (≤ 3.3) at Week 48: Etanercept and Methotrexate vs. Methotrexate Monotherapy | 52.9 percentage of participants |
p-value: 0.00695% CI: [7.9, 40.5]Chi-squared, Corrected
Secondary
SDAI Score at All Measured Timepoints
The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease.
Time frame: Baseline, Week 12, Week 24, Week 36 and Week 48
Population: Primary Analysis Set: all randomized participants. Observed cases at given timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | SDAI Score at All Measured Timepoints | Week 48 | 3.41 score on a scale | Standard Error 0.4 |
| Double-Blind Treatment: Methotrexate Monotherapy | SDAI Score at All Measured Timepoints | Week 24 | 5.61 score on a scale | Standard Error 0.98 |
| Double-Blind Treatment: Methotrexate Monotherapy | SDAI Score at All Measured Timepoints | Week 36 | 4.03 score on a scale | Standard Error 0.62 |
| Double-Blind Treatment: Methotrexate Monotherapy | SDAI Score at All Measured Timepoints | Baseline | 1.29 score on a scale | Standard Error 0.1 |
| Double-Blind Treatment: Methotrexate Monotherapy | SDAI Score at All Measured Timepoints | Week 12 | 7.01 score on a scale | Standard Error 1.01 |
| Double-Blind Treatment: Etanercept Monotherapy | SDAI Score at All Measured Timepoints | Baseline | 1.26 score on a scale | Standard Error 0.14 |
| Double-Blind Treatment: Etanercept Monotherapy | SDAI Score at All Measured Timepoints | Week 24 | 4.98 score on a scale | Standard Error 0.92 |
| Double-Blind Treatment: Etanercept Monotherapy | SDAI Score at All Measured Timepoints | Week 12 | 4.37 score on a scale | Standard Error 0.75 |
| Double-Blind Treatment: Etanercept Monotherapy | SDAI Score at All Measured Timepoints | Week 48 | 2.33 score on a scale | Standard Error 0.23 |
| Double-Blind Treatment: Etanercept Monotherapy | SDAI Score at All Measured Timepoints | Week 36 | 2.25 score on a scale | Standard Error 0.36 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | SDAI Score at All Measured Timepoints | Week 24 | 3.28 score on a scale | Standard Error 0.77 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | SDAI Score at All Measured Timepoints | Week 36 | 2.41 score on a scale | Standard Error 0.4 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | SDAI Score at All Measured Timepoints | Week 48 | 2.86 score on a scale | Standard Error 0.92 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | SDAI Score at All Measured Timepoints | Baseline | 1.18 score on a scale | Standard Error 0.17 |
| Double-Blind Treatment: Etanercept Plus Methotrexate | SDAI Score at All Measured Timepoints | Week 12 | 4.39 score on a scale | Standard Error 1.22 |
Comparison: Baselinep-value: 0.5895% CI: [-0.48, 0.27]two sample t-test
Comparison: Baselinep-value: 0.8595% CI: [-0.37, 0.31]two sample t-test
Comparison: Week 12p-value: 0.1295% CI: [-5.89, 0.67]two sample t-test
Comparison: Week 12p-value: 0.03795% CI: [-5.12, -0.16]two sample t-test
Comparison: Week 24p-value: 0.06395% CI: [-4.8, 0.13]two sample t-test
Comparison: Week 24p-value: 0.6495% CI: [-3.27, 2.01]two sample t-test
Comparison: Week 36p-value: 0.03195% CI: [-3.09, -0.15]two sample t-test
Comparison: Week 36p-value: 0.01595% CI: [-3.2, -0.35]two sample t-test
Comparison: Week 48p-value: 0.5895% CI: [-2.55, 1.45]two sample t-test
Comparison: Week 48p-value: 0.0295% CI: [-1.99, -0.17]two sample t-test
Secondary
Time to Disease Worsening
Disease worsening is defined as any of the following: * an SDAI \> 3.3 and ≤ 11 during 2 consecutive visits at least 2 weeks apart * SDAI \> 3.3 and ≤ 11 on 3 or more separate visits * SDAI \> 11 after randomization. The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
Time frame: up to Week 48
Population: Primary Analysis Set: all randomized participants. Participants with disease worsening.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Time to Disease Worsening | 12.14 weeks |
| Double-Blind Treatment: Etanercept Monotherapy | Time to Disease Worsening | 13.21 weeks |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Time to Disease Worsening | 18.93 weeks |
p-value: <0.001Log Rank
p-value: <0.001Log Rank
Secondary
Time to Recapture SDAI Remission After Starting Rescue Treatment
In participants who receive rescue treatment during the double-blind treatment period. The SDAI is a composite score that is based on the number of tender and swollen joints using a 28-joint count, Physician's Global Assessment of Disease Activity using a visual analog scale (VAS) where 0=no activity at all and 100=worst activity imaginable, Patient's Global Assessment of Disease Activity using a VAS where 0=no arthritis activity at all and 100=worst arthritis activity imaginable, and C-reactive protein (CRP) in mg/dL. The SDAI score ranges from 0 to 86, with higher scores representing worse disease. SDAI remission was defined as a score of ≤ 3.3.
Time frame: Between rescue and remission or Week 48, whichever comes first.
Population: Rescue Analysis Set: randomized participants who met the definition of disease-worsening and received both at least 1 dose of active rescue therapy etanercept and at least 1 dose of active rescue therapy methotrexate. Participants who recaptured SDAI remission. Observed cases.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Double-Blind Treatment: Methotrexate Monotherapy | Time to Recapture SDAI Remission After Starting Rescue Treatment | 11.00 weeks |
| Double-Blind Treatment: Etanercept Monotherapy | Time to Recapture SDAI Remission After Starting Rescue Treatment | 12.00 weeks |
| Double-Blind Treatment: Etanercept Plus Methotrexate | Time to Recapture SDAI Remission After Starting Rescue Treatment | 11.36 weeks |
p-value: 0.31Log Rank
p-value: 0.51Log Rank