Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel
Brief summary
This is an open label, multicenter study for extended treatment of patients who have participated in the Immunex clinical study 016.0012. The primary objective of this study is to evaluate the long term safety of etanercept (TNFR:Fc) in patients with early stage rheumatoid arthritis.
Interventions
BIOLOGICALEtanercept
Etanercept (TNFR:Fc) will be administered 50 mg per week as two 25 mg subcutaneous injections at separate sites, given either on the same day or 3 or 4 days apart.
Sponsors
Immunex Corporation
Amgen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Previous enrollment in Immunex protocol 016.0012. * No clinically significant adverse events thought to be due to etanercept (TNFR:Fc) during previous treatment. * Negative serum pregnancy test not more than 14 days before the first dose of study drug in females of childbearing potential. * No more than one NSAID at a dose not greater than the maximum recommended dose and stable for at least two weeks prior to administration of etanercept (TNFR:Fc).
Exclusion criteria
* Previous receipt of etanercept (TNFR:Fc) (p55), antibody to TNF, anti-CD4 antibody, or diphtheria IL-2 fusion protein. * Receipt of investigational drugs or biologics (other than etanercept (TNFR:Fc)) within interval between study drug in 016.0012 and this study. * Receipt of DMARDs (e.g., hydroxychloroquine, oral or injectable gold, azathioprine, cyclosporin, D-penicillamine, sulfasalazine, minocycline, or leflunomide) other than MTX within two weeks prior to the first dose of etanercept (TNFR:Fc) in this study. * Receipt of cyclophosphamide within 1 month prior to the first dose of etanercept (TNFR:Fc) in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Exposure to Etanercept With Gaps | Up to 8 years | Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment. |
| Total Exposure-Adjusted Rate of Malignancies | Up to 8 years | Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept |
| Total Exposure-Adjusted Rate of Deaths | Up to 8 years | Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept |
| Total Exposure Adjusted Rate of Serious Infectious Events | Up to 8 years | Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept |
| Total Exposure Adjusted Rate of Lymphomas | Up to 8 years | Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept |
| Malignancy | Up to 8 years | Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept |
| Lymphoma | Up to 8 years | Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept |
| Serious Infectious Event | Up to 8 years | Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication |
| Total Exposure Adjusted Rate of Serious Adverse Events | Up to 8 years | Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100) |
| Death | Up to 8 years | Death of the participant on study up to 30 days after the last dose of etanercept |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Improvement in Tender Joint Count From Baseline to Month 12 | Baseline and month 12 | Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point. |
| Percent Improvement in Swollen Joint Count From Baseline to Month 12 | Baseline and month 12 | Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12. |
| Percent Improvement in HAQ DI From Baseline to Month 12 | Baseline and month 12 | Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12. |
| Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12 | Baseline and month 12 | Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health. |
| Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12 | Baseline and month 12 | Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health. |
| Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12 | Baseline and month 12 | Percent improvement in the duration of morning stiffness from baseline to month 12 |
| Change From Baseline to Year 2 in Total Sharp Score | Baseline, Year 2 | Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing. |
| Change From Baseline to Year 2 in Sharp Score Erosion Subscale | Baseline, Year 2 | Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions. |
| Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale | Baseline, Year 2 | Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing. |
| Percent Improvement in C-Reactive Protein From Baseline to Month 12 | Baseline and month 12 | Percent improvement in C-reactive protein from baseline to month 12 |
| ACR20 Response at Month 3 | Baseline and month 3 | American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate) |
| Dosing Period | Up to 8 years | Duration of etanercept dosing |
| ACR20 Response at Month 12 | Baseline and month 12 | American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults |
| ACR50 Response at Month 12 | Baseline and month 12 | American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults |
| ACR70 Response at Month 12 | Baseline and month 12 | American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults |
| Standardized Incidence Rate for All SEER Cancers | Up to 8 years | Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data. |
| Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12 | Baseline and month 12 | Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms |
| Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12 | Baseline and Month 12 | Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms |
| Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12 | Baseline and month 12 | Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from no pain (0 cm) to severe pain (10 cm). |
Participant flow
Recruitment details
Participants were enrolled from 3 March 1999 through 17 Mar 2000
Participants by arm
| Arm | Count |
|---|---|
| Etanercept (Enbrel) Etanercept 50 mg subcutaneous dose weekly | 468 |
| Total | 468 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 54 |
| Overall Study | Completed month 12 only | 2 |
| Overall Study | Death | 10 |
| Overall Study | Lost to Follow-up | 35 |
| Overall Study | Other | 52 |
| Overall Study | Physician Decision | 46 |
| Overall Study | Protocol issues | 6 |
| Overall Study | Response status | 28 |
| Overall Study | Withdrawal by Subject | 41 |
Baseline characteristics
| Characteristic | Etanercept (Enbrel) |
|---|---|
| Age Continuous | 51.38 Year STANDARD_DEVIATION 12.38 |
| C-Reactive Protein | 3.28 mg/dL STANDARD_DEVIATION 4.9 |
| Duration of Morning Stiffness | 182.24 Minutes STANDARD_DEVIATION 286.63 |
| Health Assessment Questionnaire Disability Index | 1.30 Units on a scale STANDARD_DEVIATION 0.67 |
| Mental Component Summary Score from SF-36 | 48.28 Units on a scale STANDARD_DEVIATION 11.52 |
| Participant Global Assessment of Disease Status | 5.51 Units on a scale STANDARD_DEVIATION 2.27 |
| Participant Pain Visual Analog Scale | 5.01 Units on a scale STANDARD_DEVIATION 2.62 |
| Physical Component Summary Score from SF-36 | 30.42 Units on a scale STANDARD_DEVIATION 9.69 |
| Physician Global Assessment of Disease Status | 5.32 Units on a scale STANDARD_DEVIATION 2.3 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 4 Participant |
| Race/Ethnicity, Customized Asian | 5 Participant |
| Race/Ethnicity, Customized Black or African American | 23 Participant |
| Race/Ethnicity, Customized Hispanic or Latino | 25 Participant |
| Race/Ethnicity, Customized Other | 4 Participant |
| Race/Ethnicity, Customized White or Caucasian | 407 Participant |
| Sex: Female, Male Female | 351 Participants |
| Sex: Female, Male Male | 117 Participants |
| Swollen Joint Count | 20.30 Joints STANDARD_DEVIATION 12.6 |
| Tender Joint Count | 25.81 Joints STANDARD_DEVIATION 16.71 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 320 / 468 |
| serious Total, serious adverse events | 169 / 468 |
Outcome results
Primary
Death
Death of the participant on study up to 30 days after the last dose of etanercept
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Death | 10 Participants |
Primary
Lymphoma
Occurrence of one or more lymphomas on study within 30 days of the last dose of etanercept
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Lymphoma | 6 Participants |
Primary
Malignancy
Occurrence of one or more malignancies within the participant on study within 30 days of the last dose of etanercept
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Malignancy | 31 Participants |
Primary
Serious Infectious Event
Occurrence of one or more serious infectious events within the participant on study within 30 days of the last dose of study medication
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Serious Infectious Event | 51 Participants |
Primary
Total Exposure-Adjusted Rate of Deaths
Rate of deaths within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Total Exposure-Adjusted Rate of Deaths | 0.35 Deaths per 100 participant-years |
Primary
Total Exposure Adjusted Rate of Lymphomas
Rate of lymphomas occurring on study within 30 days of the last dose of etanercept, adjusted for total exposure to etanercept
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Total Exposure Adjusted Rate of Lymphomas | 0.24 Lymphomas per 100 participant-years |
Primary
Total Exposure-Adjusted Rate of Malignancies
Exposure-adjusted rate of malignancies, excluding nonmelanoma skin cancers, occurring on study within 30 days of the last dose of etanercept
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Total Exposure-Adjusted Rate of Malignancies | 1.32 Malignancies per 100 participant-years |
Primary
Total Exposure Adjusted Rate of Serious Adverse Events
Rate of serious adverse events adjusted to total exposure to etanercept (events / exposure \* 100)
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Total Exposure Adjusted Rate of Serious Adverse Events | 13.84 Events per 100 patient-years |
Primary
Total Exposure Adjusted Rate of Serious Infectious Events
Exposure-adjusted rate of serious infectious events (associated with hospitalization or IV antibiotics) occurring on study within 30 days of the last dose of etanercept
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Total Exposure Adjusted Rate of Serious Infectious Events | 2.88 Events per 100 participant-years |
Primary
Total Exposure to Etanercept With Gaps
Total participant exposure to etanercept (Enbrel) with gaps, calculated as the sum of the times on treatment for all participants. Gaps of up to 14 days from the last treatment in a previous Etanercept study were ignored in calculating time on treatment.
Time frame: Up to 8 years
Population: All enrolled participants who received at least one dose of etanercept
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | Total Exposure to Etanercept With Gaps | 2882.50 Participant-years |
Secondary
ACR20 Response at Month 12
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data at month 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | ACR20 Response at Month 12 | 262 Participants |
Secondary
ACR20 Response at Month 3
American College of Rheumatology (ACR) 20, defined as a 20% improvement in both tender and swollen joints (78 joints) and a 20% improvement in 3 of 5 items (physician and patient global assessments, patient pain assessment, patient self-assessed disability, and acute-phase C-reactive protein or erythrocyte sedimentation rate)
Time frame: Baseline and month 3
Population: All enrolled participants who received at least one dose of etanercept and had available data at month 3
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | ACR20 Response at Month 3 | 276 Participants |
Secondary
ACR50 Response at Month 12
American College of Rheumatology (ACR) 50, defined as a 50% improvement in both tender and swollen joints (78 joints) and a 50% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data at month 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | ACR50 Response at Month 12 | 192 Participants |
Secondary
ACR70 Response at Month 12
American College of Rheumatology (ACR) 70, defined as a 70% improvement in both tender and swollen joints (78 joints) and a 70% improvement in 3 of 5 items (including physician and patient global assessments), in adults
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data at month 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Etanercept (Enbrel) | ACR70 Response at Month 12 | 110 Participants |
Secondary
Change From Baseline to Year 2 in Sharp Score Erosion Subscale
Change from baseline to year 2 in the joint erosion subscale of the Total Sharp Score. This subscale has a range of 0 to 230, where 0 = no change and higher values represent a worsening in joint erosions.
Time frame: Baseline, Year 2
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept (Enbrel) | Change From Baseline to Year 2 in Sharp Score Erosion Subscale | 0.54 Units on a scale |
Secondary
Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale
Change from baseline to year 2 in the joint space narrowing subscale of the Total Sharp Score. This subscale has a range of 0 to 168, where 0 = no change and higher values represent a worsening of joint space narrowing.
Time frame: Baseline, Year 2
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept (Enbrel) | Change From Baseline to Year 2 in Sharp Score Joint Space Narrowing Subscale | 0.64 Units on a scale |
Secondary
Change From Baseline to Year 2 in Total Sharp Score
Change from baseline to year 2 in Total Sharp Score. This score has a range of 0 to 398, where 0 = no change and higher scores represent a worsening of joint erosions and joint space narrowing.
Time frame: Baseline, Year 2
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and year 2
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept (Enbrel) | Change From Baseline to Year 2 in Total Sharp Score | 1.17 Units on a scale |
Secondary
Dosing Period
Duration of etanercept dosing
Time frame: Up to 8 years
Population: All participants who received at least one dose of etanercept
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Dosing Period | 2249.6 Days | Standard Deviation 1180 |
Secondary
Percent Improvement in C-Reactive Protein From Baseline to Month 12
Percent improvement in C-reactive protein from baseline to month 12
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in C-Reactive Protein From Baseline to Month 12 | 31.57 Percent change | Standard Deviation 132.83 |
Secondary
Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12
Percent improvement in the duration of morning stiffness from baseline to month 12
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in Duration of Morning Stiffness From Baseline to Month 12 | 44.08 Percent change | Standard Deviation 156.2 |
Secondary
Percent Improvement in HAQ DI From Baseline to Month 12
Percent improvement in the Health Assessment Questionnaire Disability Index (HAQ DI) from baseline to month 12.
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in HAQ DI From Baseline to Month 12 | 40.91 Percent change | Standard Deviation 66.09 |
Secondary
Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12
Percent improvement in the Mental Component Summary Score of the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in Mental Component Summary Score of SF-36 From Baseline to Month 12 | -12.31 Percent change | Standard Deviation 31.48 |
Secondary
Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12
Percent improvement in the Participant Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
Time frame: Baseline and Month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in Participant Global Assessment of Disease Status From Baseline to Month 12 | 35.46 Percent change | Standard Deviation 60.62 |
Secondary
Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12
Percent improvement in the Participant Pain Visual Analog Scale (VAS) from baseline to month 12, using a 10 cm scale ranging from no pain (0 cm) to severe pain (10 cm).
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in Participant Pain Visual Analog Scale From Baseline to Month 12 | 30.64 Percent change | Standard Deviation 103.25 |
Secondary
Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12
Percent improvement in the Physician Global Assessment of disease status from baseline to month 12, assessed using a 0 - 10 Likert scale, where 0 = asymptomatic and 10 = severe symptoms
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in Physician Global Assessment of Disease Status From Baseline to Month 12 | 50.07 Percent change | Standard Deviation 58.07 |
Secondary
Percent Improvement in Swollen Joint Count From Baseline to Month 12
Percent improvement in swollen joint count (based on up to 68 joints) from baseline to month 12.
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in Swollen Joint Count From Baseline to Month 12 | 52.04 Percent change | Standard Deviation 87.97 |
Secondary
Percent Improvement in Tender Joint Count From Baseline to Month 12
Percent improvement in tender joint count (based on up to 71 joints) from baseline to month 12. Tender joints were assessed clinically, and the number of such joints was counted at each time point.
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in Tender Joint Count From Baseline to Month 12 | 49.70 Percent change | Standard Deviation 147.16 |
Secondary
Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12
Percent improvement in the Physical Component Summary Score for the Short Form 36 Health Survey (SF-36) from baseline to month 12. This score has a range of 0 to 100, with higher scores indicating better health.
Time frame: Baseline and month 12
Population: All enrolled participants who received at least one dose of etanercept and had available data for this outcome measure at baseline and month 12
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etanercept (Enbrel) | Percent Improvement in the Physical Component Summary Score for SF-36 From Baseline to Month 12 | -39.65 Percent change | Standard Deviation 55.43 |
Secondary
Standardized Incidence Rate for All SEER Cancers
Standardized incidence rate for all cancers tracked by the National Cancer Institute's Surveillance Epidemiology and End Results (SEER) system, calculated as the ratio of the observed to expected age- and sex-adjusted incidence rates (per person-year) of cancer. Expected rates were based on 1998-2002 SEER data.
Time frame: Up to 8 years
Population: All participants who received at least one dose of etanercept
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Etanercept (Enbrel) | Standardized Incidence Rate for All SEER Cancers | 0.99 Standardized incidence rate |