American College of Rheumatology (ACR) criteria improvement consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-Blind period.

Intent-to-treat population (ITT): all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study.

American College of Rheumatology (ACR) criteria improvement consisting of 50% or 70% (ACR50/70) reduction in tender or swollen joint counts and 50% or 70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit. Week 12 = end of Double-blind period.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), non-responder imputation (NRI; missing ACR responses imputed as non-responders).

American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 20% (ACR20) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 50% (ACR50) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

American College of Rheumatology (ACR) criteria improvement in a subject's disease condition versus Baseline consisting of 70% (ACR70) reduction in tender or swollen joint counts and 20/50/70% improvement in 3 of the following 5 criteria: 1) physician's global assessment of disease activity, 2) subject's assessment of disease activity, 3) subject's assessment of pain, 4) subject's assessment of functional disability via a health assessment questionnaire, and 5) C-reactive protein at each visit.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).

Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

Sixty-eight or 66 joints or regions (34 or 32 per body side [hip joints excluded]) were assessed by pressure and joint manipulation on physical examination for tender joint count (TJC) or swollen joint count (SJC), respectively. Both joint tenderness and swelling were classified as either present ("1"), absent ("0"), replaced ("9"), or no assessment ("NA"). The Total TJC or SJC was derived as the sum of all 1s evaluated; the range for TJC and SJC were 0 - 68 and 0 - 66, respectively. The higher the joint count, the worse the rheumatoid arthritis. Week 12 = end of Double-Blind period.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state. Week 12 = end of Double-Blind period.

Intent-to-Treat (ITT) population (all subjects who received at least 1 dose of study drug during the double-blind period), Last Observation Carried Forward (LOCF).

Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

Visual analog scale (VAS) was used for the physician's (PhGA) and patient's (PGA) global assessment of disease activity and the patient's assessment of pain. PhGA assessed the patient's current status, PGA assessed status within the last 24 h, and patient's assessment of pain assessed pain status during the last week. All 3 assessments were scored on a 100 mm horizontal scale. The scores range from 0 (no symptoms) to 100 (maximum symptoms); therefore lower VAS scores represent a better disease state.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index = improvement in disease (0 = no difficulties). Week 12 = end of Double-Blind period.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the double-blind portion of the study), Last Observation Carried Forward (LOCF).

HAQ is a self-reported, subject-oriented outcome measure. The Standard Disability Index of HAQ for a subject is calculated as the mean of the following 8 category scores (range: 0-3): dressing and grooming, rising, eating, walking, hygiene, reach, grip, and activities. The score of each category is calculated as the maximum of the scores for the questions of that category. The Disability Index cannot be computed if the patient does not have scores for at least 6 categories. A decrease in the Disability Index indicates an improvement in disease (0 = no difficulties).

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period. Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Double-Blind portion of the study), Observed cases included.

SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.

SF-36 (v.2) is a standardized health survey consisting of 36 questions to measure functional health status. The SF-36 score has two components: physical (PCS) and mental (MCS). Summary scores are calculated using the following 8 scales: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. The score for a component is an average of the individual question scores, which are scaled 0 (not functioning) to 100 (highest functioning). An increase in SF-36 PCS or MCS indicates improved health status.

Intent-to-Treat (ITT) population (all randomized subjects who received at least 1 dose of study drug during the Open-Label period). Participant numbers are reduced from the Double-Blind period as not all enrolled participants in the DB period also enrolled in the OL period.