Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study

Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 6

时间窗: 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 12

时间窗: 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.

Patient Global Assessment (PtGA) of Disease Activity Score at Month 9

时间窗: 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

时间窗: 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 6

时间窗: 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.

Visual Analogue Scale for Pain (VAS-pain) at Month 6

时间窗: Month 6

10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.

Percentage of Participants With Disease Activity Score Based on 28-joints Count (DAS28) Remission at Month 9

时间窗: 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 3

时间窗: 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.

Disease Activity Score Based on 28-joints Count (DAS28) at Month 12

时间窗: 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 6

时间窗: Month 6

PtGA measured using a 10 cm (VAS) ranging from 0 cm = very good to 10 cm = very bad.

Visual Analogue Scale for Pain (VAS-pain) at Month 3

时间窗: Month 3

10 cm line (VAS) marked by participant. Intensity of pain range 0 cm = no pain to 10 cm = worst possible pain.

Number of Participants With Rheumatoid Factor (RF) at Month 9

时间窗: 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.

Disease Activity Score Based on 28-joints Count (DAS28) at Month 3

时间窗: 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.

Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 3

时间窗: 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.

Disease Activity Score Based on 28-joints Count (DAS28) at Month 6

时间窗: 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

时间窗: 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.

Patient Global Assessment (PtGA) of Disease Activity Score at Month 3

时间窗: Month 3

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

时间窗: 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 9

时间窗: 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

时间窗: 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 9

时间窗: 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

时间窗: 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

时间窗: 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 12

时间窗: Month 12

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

时间窗: 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

时间窗: Month 9

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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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 12

时间窗: 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-nuclear Antibodies at Month 3

时间窗: 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 9

时间窗: 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-deoxyribonucleic Acid (Anti-DNA) Antibodies at Month 3

时间窗: 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 12

时间窗: 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.

Number of Participants With Anti-cyclic Citrullinated Protein (Anti-CCP) Antibodies at Month 6

时间窗: 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

时间窗: 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

时间窗: 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 6

时间窗: 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 12

时间窗: 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 6

时间窗: 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

时间窗: 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.

Duration of Morning Stiffness at Month 3

时间窗: 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

时间窗: 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.

Stanford Health Assessment Questionnaire (HAQ) Score at Month 6

时间窗: 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).

Duration of Morning Stiffness at Month 9

时间窗: 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

时间窗: 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

时间窗: 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 9

时间窗: 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

时间窗: 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

时间窗: 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).