An AE was defined as any untoward medical occurrence in a clinical investigation participant that was administered study drug, regardless of causal attribution.

All participants receiving study drug were included in the safety analysis set.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.

The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included swollen joint count (SJC), tender joint count (TJC), acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status (GH). For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC 28]) + (0.28 × √[SJC 28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 48 - DAS28-ESR at Baseline.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.

The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index included SJC, TJC, acute phase response (ESR or high sensitivity C-reactive protein [hsCRP]) and general health status. For this study, ESR was used to calculate DAS28 score. The index was calculated using the following formula: DAS28 = (0.56 × √[TJC28]) + (0.28 × √[SJC28]) + (0.7 × ln[ESR]) + (0.014 × GH). The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity. Change in DAS28ESR=DAS28-ESR at Week 96 - DAS28-ESR at Baseline.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.

The SDAI was the numerical sum of five outcome parameter: SJC and TJC, Patient Global Assessment of Disease Activity (PGA) and Investigator Global Assessment of Disease Activity (IGA), and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 48 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity. Here, n signifies the number of subjects evaluable at the specified time points.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.

The SDAI was the numerical sum of five outcome parameter: SJC and TJC, PGA and IGA, and level of hsCRP. The index was calculated using the following formula SDAI = TJC28 + SJC28 + PGA + IGA + CRP. Change in SDAI = SDAI at Week 96 - SDAI at Baseline. SDAI total score = 0-86. SDAI <=3.3 indicates clinical remission, >3.4 to 11 = low disease activity, >11 to 26 = moderate disease activity, and >26 = high (or severe) disease activity.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.

An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement. Here, 'n' represents the number of participants with a measure at specified time point.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.

An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A smaller number indicated improvement.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Number of participants analyzed represent number of participants who were evaluable for the outcome measure.

An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. A negative number indicated improvement.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.

An assessment of 66 joints for swelling and 68 joints for tenderness was made. Joints were assessed and classified as tender/not tender and swollen/not swollen by pressure and joint manipulation on physical examination. Change in SJC = SJC at Week 96 - SJC at Baseline. A negative number indicated improvement.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration.

This assessment represents the patient's overall assessment of their current disease activity on a 100 millimeter (mm) horizontal VAS. The extreme left end of the line should be described as "no disease activity" (symptom free and no arthritis symptoms) and the extreme right end as "maximum disease activity" (maximum arthritis disease activity). Scores ranged from 0 to 100 with a higher score indicating more disease activity. A negative change score indicated less disease activity.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.

This assessment represents the patient's assessment of his/her current level of pain on a 100 mm horizontal VAS. The extreme left end of the line should be described as "no pain" and the extreme right end as "unbearable pain". Scores ranged from 0 to 100 with a higher score indicating more pain. A negative change score indicated less pain.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.

The HAQ-DI is a questionnaire specific for rheumatoid arthritis and consists of 20 questions referring to 8 domains: Dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities. Minimum score was 0, maximum score was 3. A smaller score indicated improvement.

Per-protocol population included all participants who had at least one dose of study medication and at least one safety evaluation after dose administration. Here, 'n' represents the number of participants with a measure at the specified time point.