Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

Number of Participants With Investigator-Identified Serious Infections

Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.

Time frame: Baseline (Day 1) up to Week 28 (Follow-up)

Number of Participants With Injection Site Reactions

Injection site reactions included injection site erythema, swelling, pain and warmth.

Time frame: Baseline (Day 1) up to Week 28 (Follow-up)

Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities

Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to\[\>=\]0.5,less than\[\<\]1.0 10\^9/L),lymphocyte (\<0.5 10\^9/L),hemoglobin (Hb) (\<80,\>=65 gram per liter \[g/L\]),platelet(\<50.0,\>=25.0 10\^9/L),white blood count(WBC) (\<2.0, \>=1.0 10\^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than\[\>\]5.0\*upper range \[UR\], \<=20.0\*UR unit per liter\[U/L\]);bilirubin(\>1.5\*UR, less than or equal to\[\<=\]3.0\*UR micromole per liter\[mcmol/L\]);creatinine(\>3.0\*UR, \<=6.0\*UR mcmol/L);albumin (\<20.0 g/L),urea(\>3.0\*UR, \<=4.0\*UR g/L);potassium (K)-high,low (\>6.0,\<=7.0or\<3.0,\>=2.5 mcmol/L); sodium(Na)-high,low(\>155, \<=160 or \<130, \>=120 mcmol/L)and Grade 4: neutrophil(\<0.5 10\^9/L),Hb (\<65 g/L);platelet (\<25.0 10\^9/L); WBC(\<1.0 10\^9/L);AP,AST,ALT(\>20.0\*UR U/L);bilirubin(\>3.0\*UR mcmol/L);creatinine (\>6.0\*UR mcmol/L);urea (\>4.0\*UR g/L);K-high,low (\>7.0or\<2.5 mcmol/L);Na-high, low (\>160or\<120 mcmol/L).

Time frame: Baseline (Day 1) up to Week 28 (Follow-up)

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.

Time frame: Week 4, 12, 24

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.

Time frame: Week 4, 12, 24

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.

Time frame: Week 4, 12, 24

Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24

DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour \[mm/hour\]) and participant's general health visual analog scale assessment (scores: 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (\<) 2.6= remission, \<3.2= low disease activity, greater than or equal to (\>=) 3.2 to 5.1= moderate disease activity and \>5.1= high disease activity.

Time frame: Baseline, Week 4, 12, 24

Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter \[mg/L\]) and participant's general health visual analog scale assessment (scores ranging 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (\<) 2.6= remission, \<3.2= low disease activity, greater than or equal to (\>=) 3.2 to 5.1= moderate disease activity and \>5.1= high disease activity.

Time frame: Baseline, Week 4, 12, 24

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24

HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Time frame: Baseline, Week 4, 12, 24