Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.

The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.

Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.

The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.

The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.

ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.

CRP is an acute phase protein. Levels of CRP increase with inflammation.

The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.

The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.

Disease stages/phases of rheumatoid arthritis (RA): Stage I represents synovitis: synovial membrane becomes hyperemic and edematous; joint effusions with high cell count; x-rays will as yet show no destructive changes, but soft tissue swelling or osteoporosis may be seen; Stage II: inflamed synovial tissue now proliferates and begins to grow into joint cavity across articular cartilage, which it gradually destroys; Stage III: pannus of synovium; eroded articular cartilage and exposed subchondral bone x-rays will show extensive cartilage loss; Stage IV represents end-stage disease.

Classification of global functional status in RA is as follows: Class I: completely able to perform usual activities of daily living (self-care, vocational, and avocational); Class II: able to perform usual self-care and vocational activities, but limited in avocational activities; Class III: able to perform usual self-care activities, but limited in vocational and avocational activities; and Class IV: limited in ability to perform usual self-care, vocational, and avocational activities.

CRP was measured in milligrams per liter (mg/L)

ESR was measured in millimeters per hour (mm/hr)

DAS28 calculated from the number of swollen joints and tender joints using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hr]) and Patient's Global Assessment of Disease Activity (participant-rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 ≤3.2 equals (=) low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

ITT Population

ITT Population

ITT Population

ITT Population

Participants were asked to rate their pain using a 0 to 100 mm visual analog scale (VAS), where 0 mm = no pain and 100 mm = worst possible pain. The participant was asked to mark the line corresponding to their perceived level of pain and the distance in mm from the left edge of the scale was measured.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

The participant's assessment of disease activity was performed using a 100 mm VAS ranging from no activity (0) to maximal activity (100). The participant was asked to mark the line corresponding to their perceived level of disease activity and the distance in mm from the left edge of the scale was measured.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

Physician's global assessment of disease activity was performed using a 100 mm VAS ranging from no arthritis activity (0) to maximal arthritis activity (100). The physician was asked to mark the line corresponding to their perceived level of the participant's disease activity and the distance in mm from the left edge of the scale was measured.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

The following 28 joints were assessed by the physician for swelling: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not swollen or 1=swollen. The total number was calculated from all the joints for a maximum score of 28.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

The following 28 joints were assessed by the physician for tenderness: metacarpophalangeal I-V (10), thumb interphalangeal (2), hand proximal interphalangeal II-V (8), wrist (2), elbow (2), shoulders (2), and knees (2). Joints were rated as 0=not tender or 1=tender. The total number was calculated from all the joints for a maximum score of 28.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

ESR indirectly measures how much inflammation is in the body. A higher ESR is indicative of increased inflammation.

TT population; n=number of participants assessed for the specified parameter at a given visit.

CRP is an acute phase protein. Levels of CRP increase with inflammation.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

The HAQ-DI was used to assess the physical ability and functional status of participants as well as quality of life. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from 4 response categories, ranging from 'without any difficulty' (Score=0) to 'unable to do' (Score=3). The overall score is the average of each of the 8 category scores and ranges from 0 to 3, where 0 represents no disability and 3 very severe, high-dependency disability.

ITT population; n=number of participants assessed for the specified parameter at a given visit.

The SF-36 measures the impact of disease on overall quality of life and consists of 8 subscales (physical function, pain, general and mental health, vitality, social function, physical and emotional health) which can be aggregated to derive a physical-component summary score and a mental-component summary score. Scores for each subscale range from 0 to 10, and the composite scores range from 0 to 100, with higher scores indicating better health.

ITT population; n=number of participants assessed for the specified parameter at a given visit.