Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trial 016.0012

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

Dosing Period

Duration of etanercept dosing

Time frame: Up to 8 years

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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