- Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 3 [ Time Frame: Month 3 ]
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA 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 less than or equal to (<=) 3.2 = low disease activity, DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 less than (<) 2.6.
- Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6 [ Time Frame: Month 6 ]
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA 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 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.
- Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9 [ Time Frame: Month 9 ]
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA 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 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 <2.6.
- Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 12 [ Time Frame: Month 12 ]
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA 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 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity. A participant is considered to be in remission if they have a DAS28 < 2.6.
- Disease Activity Score Based on 28-joints Count (DAS28) at Month 3 [ Time Frame: Month 3 ]
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA 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 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
- Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 [ Time Frame: Month 6 ]
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA 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 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
- Disease Activity Score Based on 28-joints Count (DAS28) at Month 9 [ Time Frame: Month 9 ]
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA 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 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
- Disease Activity Score Based on 28-joints Count (DAS28) at Month 12 [ Time Frame: Month 12 ]
DAS28 calculated from the SJC and PJC using the 28 joints count, the ESR (mm/hr) and PtGA 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 = low disease activity, DAS28 >3.2 to 5.1 = moderate to high disease activity.
- Patient Global Assessment (PtGA) of Disease Activity Score at Month 3 [ Time Frame: Month 3 ]
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
- Patient Global Assessment (PtGA) of Disease Activity Score at Month 6 [ Time Frame: Month 6 ]
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
- Patient Global Assessment (PtGA) of Disease Activity Score at Month 9 [ Time Frame: Month 9 ]
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
- Patient Global Assessment (PtGA) of Disease Activity Score at Month 12 [ Time Frame: Month 12 ]
PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.
- Physician Global Assessment (PGA) of Disease Activity at Month 3 [ Time Frame: Month 3 ]
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
- Physician Global Assessment (PGA) of Disease Activity at Month 6 [ Time Frame: Month 6 ]
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
- Physician Global Assessment (PGA) of Disease Activity at Month 9 [ Time Frame: Month 9 ]
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
- Physician Global Assessment (PGA) of Disease Activity at Month 12 [ Time Frame: Month 12 ]
PGA was measured on a 0 to 10 cm VAS, with 0 cm = no disease activity to 10 cm = worst disease activity possible.
- Visual Analogue Scale for Pain (VAS-pain) at Month 3 [ Time Frame: Month 3 ]
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
- Visual Analogue Scale for Pain (VAS-pain) at Month 6 [ Time Frame: Month 6 ]
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
- Visual Analogue Scale for Pain (VAS-pain) at Month 9 [ Time Frame: Month 9 ]
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
- Visual Analogue Scale for Pain (VAS-pain) at Month 12 [ Time Frame: Month 12 ]
10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.
- C-reactive Protein (CRP) at Month 3 [ Time Frame: Month 3 ]
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
- C-reactive Protein (CRP) at Month 6 [ Time Frame: Month 6 ]
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
- C-reactive Protein (CRP) at Month 9 [ Time Frame: Month 9 ]
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
- C-reactive Protein (CRP) at Month 12 [ Time Frame: Month 12 ]
CRP is a marker of inflammation. CRP value higher than 0.5 mg/dL is consistent with inflammation.
- Erythrocyte Sedimentation Rate (ESR) at Month 3 [ Time Frame: Month 3 ]
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
- Erythrocyte Sedimentation Rate (ESR) at Month 6 [ Time Frame: Month 6 ]
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
- Erythrocyte Sedimentation Rate (ESR) at Month 9 [ Time Frame: Month 9 ]
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
- Erythrocyte Sedimentation Rate (ESR) at Month 12 [ Time Frame: Month 12 ]
ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 mm/hr. A higher rate is consistent with inflammation.
- Number of Participants With Rheumatoid Factor (RF) at Month 3 [ Time Frame: Month 3 ]
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
- Number of Participants With Rheumatoid Factor (RF) at Month 6 [ Time Frame: Month 6 ]
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
- Number of Participants With Rheumatoid Factor (RF) at Month 9 [ Time Frame: Month 9 ]
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
- Number of Participants With Rheumatoid Factor (RF) at Month 12 [ Time Frame: Month 12 ]
RF is the auto antibody directed against IgG and its concentration is observed in human serum or plasma. RF value higher than 20 U/mL is considered positive.
- Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3 [ Time Frame: Month 3 ]
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
- Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6 [ Time Frame: Month 6 ]
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
- Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 9 [ Time Frame: Month 9 ]
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
- Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 12 [ Time Frame: Month 12 ]
Anti-CCP antibodies are auto antibodies (antibodies directed against 1 or more of an individual's own proteins) that are frequently detected in the blood of rheumatoid arthritis participants. Anti-CCP antibodies value higher than 10 U/mL is considered positive.
- Number of Participants With Anti-nuclear Antibodies at Month 3 [ Time Frame: Month 3 ]
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
- Number of Participants With Anti-nuclear Antibodies at Month 6 [ Time Frame: Month 6 ]
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
- Number of Participants With Anti-nuclear Antibodies at Month 9 [ Time Frame: Month 9 ]
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
- Number of Participants With Anti-nuclear Antibodies at Month 12 [ Time Frame: Month 12 ]
Anti-nuclear antibodies are auto antibodies directed against contents of the nucleus and are present in higher than normal numbers in autoimmune disease. Anti-nuclear antibodies value higher than 1:160 is considered positive.
- Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3 [ Time Frame: Month 3 ]
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
- Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 6 [ Time Frame: Month 6 ]
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
- Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 9 [ Time Frame: Month 9 ]
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
- Number of Participants With Anti-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 12 [ Time Frame: Month 12 ]
Anti-DNA antibodies are auto antibodies directed against DNA and are present in higher than normal numbers in autoimmune disease. Anti-DNA antibodies value higher than 1:20 is considered positive.
- Duration of Morning Stiffness at Month 3 [ Time Frame: Month 3 ]
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
- Duration of Morning Stiffness at Month 6 [ Time Frame: Month 6 ]
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
- Duration of Morning Stiffness at Month 9 [ Time Frame: Month 9 ]
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
- Duration of Morning Stiffness at Month 12 [ Time Frame: Month 12 ]
Duration of morning stiffness: Time elapsed when participant woke up in morning and was able to resume normal activities without stiffness in minutes. Increase in stiffness duration from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represented improvement.
- Stanford Health Assessment Questionnaire (HAQ) Score at Month 3 [ Time Frame: Month 3 ]
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
- Stanford Health Assessment Questionnaire (HAQ) Score at Month 6 [ Time Frame: Month 6 ]
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
- Stanford Health Assessment Questionnaire (HAQ) Score at Month 9 [ Time Frame: Month 9 ]
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
- Stanford Health Assessment Questionnaire (HAQ) Score at Month 12 [ Time Frame: Month 12 ]
HAQ is a measure of functional limitations. Participants were rated on 4 point scale with scores: 0=no difficulty (normal), 1=some difficulty (adequate), 2=much difficulty (limited), 3=unable to do based on degree of difficulty experienced with 20 tasks grouped into 8 areas of dressing, rising, hygiene, reach, walking, eating, grip and activities. The higher score reported by the participant for any component question of the 8 categories determines the score for that categories. Total score is divided for 8. Average score range: 0 (no difficulty) to 3 (unable to do).
- 36-Item Short-Form Health Survey (SF-36) at Month 12 [ Time Frame: Month 12 ]
SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
