Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice

The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.

Time frame: Month 6 up to Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from swollen joint count (SJC) and tender/painful joint count (TJC) using 28 joints count, C-reactive protein (CRP) (milligrams per liter \[mg/L\]) or erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hr\]) levels and patient global assessment (PGA) of disease activity on a 0-100 mm scale (scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 \[less than or equal to\] \<=3.2 implied low disease activity and greater than (\>) 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28 less than (\<) 2.6 implied remission.

Time frame: Month 6 up to Month 12

Population: The completers analysis data set (CAS) consisted of all participants enrolled in study and who completed 12-month study, whether or not they missed some follow-up visits and regardless of cohort (first or second intention). Here, N (number of participants analyzed) signifies participants who were evaluable for this specified outcome measure.

The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1 and PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition).

Time frame: Month 6 up to Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1; CRP\<=1 mg/dl; PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition).

Time frame: Month 6 up to Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

Remission based on DAS28 + US7: DAS28 \<2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).

Time frame: Month 6 up to Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

A participant was in remission based on US7: if US7 synovitis sum score in grey-scale Ultrasonography (GSUS) =0, Power Doppler Ultrasonography (PDUS) =0 and erosion sum score in GSUS=0. US7 score is musculoskeletal ultrasonography (MKUS) composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, metacarpophalangeal (MCP) II and III, proximal interphalangeal (PIP) II and III, metatarsophalangeal (MTP) II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.

Time frame: Month 6 up to Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, physician (evaluator) global assessment of disease (EGA) and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI \>3.4 to 11 implied low disease activity, \>11 to 26 implied moderate disease activity, \>26 implied high disease activity and \<=3.3 implied disease remission.

Time frame: Month 6 up to Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.

Time frame: Baseline, Month 6 and Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 \<=3.2 implied low disease activity and \> 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28 \<2.6 implied remission.

Time frame: Baseline, Month 6 and Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the erosions. The joints were examined by GSUS for erosions from a dorsal, palmar/plantar and radial/lateral (only MCP 2 and MTP 5) aspect. The US7 erosion sum score in GSUS was the sum of the 14 following scores (MCP 2 dorsal, MCP 2 palmar, MCP 2 radial, MCP 3 dorsal, MCP 3 palmar, PIP 2 dorsal, PIP 2 palmar, PIP 3 dorsal, PIP 3 palmar, MTP 2 dorsal, MTP 2 plantar, MTP 5 dorsal, MTP 5 plantar and MTP 5 lateral) ranging from 0 to 1. Total score ranged from 0 (no erosions) to 14 (severe erosions), higher score= more erosions. The score was based on measurements made at fingers and toes and were calculated for both left and right sides, the score of the clinically most affected side.

Time frame: Month 6 and Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. GSUS is a scoring system use to determine synovitis. The joints were examined by GSUS for synovitis from a dorsal and palmar aspect. The US7 synovitis sum score in GSUS was the sum of the scores for 9 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 3 palmar, PIP 2 palmar, PIP 3 palmar, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0 =no synovitis to 3=severe synovitis. Total US7 GSUS score ranged from 0 (no synovitis) to 27 (severe synovitis), higher score= more synovitis.

Time frame: Baseline, Month 6 and Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 synovitis sum score in PDUS was the sum of the scores of 13 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 palmar, MCP 2 dorsal, MCP 3 palmar, MCP 3 dorsal, PIP 2 palmar, PIP 2 dorsal, PIP 3 palmar, PIP 3 dorsal, MTP 2 dorsal, MTP 5 dorsal) on a scale ranging from 0=no intraarticular color signal to 3 = \>=50% of the intraarticular area filled with color signals. Total US7 PSUS scores ranges from 0=no intraarticular color signal to 39 = \>=50% of the intraarticular area filled with color signals; higher scores= more severe disease.

Time frame: Baseline, Month 6 and Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. GSUS was a scoring system used to determine the tenosynovitis/paratenonitis. The joints were examined by GSUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in GSUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP I2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis GSUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.

Time frame: Baseline, Month 6 and Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

US7 score was MKUS composite scoring system which combined soft tissue lesions (synovitis and tenosynovitis/paratenonitis) and destructive processes (erosions) in a single scoring system. PDUS assessed the degree of synovial inflammation of the joints of both hands. The joints were examined by PDUS from a dorsal and palmar aspect. The US7 tenosynovitis/paratenonitis sum score in PDUS was the sum of the scores for 7 following parts (wrist dorsal, wrist palmar, wrist ulnar, MCP 2 dorsal, MCP 2 palmar, MCP 3 dorsal, MCP 3 palmar) on a scale ranging from 0 =no synovitis to 1=severe synovitis. Total US7 tenosynovitis/paratenonitis PDUS score ranged from 0 (no synovitis) to 7 (severe synovitis), higher score= more synovitis.

Time frame: Baseline, Month 6 and Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI \>3.4 to 11 implied low disease activity, \>11 to 26 implied moderate disease activity, \>26 implied high disease activity and \<=3.3 implied disease remission.

Time frame: Baseline, Month 6 and Month 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

The CDAI was the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition). CDAI total score ranged from 0-76 with higher scores indicating increased disease activity.

Time frame: Month 3, 6, 9 and 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

DAS28 was a measure of disease activity in participants with rheumatoid arthritis. DAS28 was calculated from SJC and TJC using 28 joints count, CRP (mg/L) or ESR) (mm/hr) levels and PGA of disease activity on a 0-100 mm scale (scores ranging from 0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). DAS28 score range from 0 (none) to 9.4 (extreme disease activity). DAS28 \<=3.2 implied low disease activity and \> 3.2 to \<=5.1 implied moderate disease activity, \>5.1 implied high disease activity, and DAS28 \<2.6 implied remission.

Time frame: Month 3, 6, 9 and 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

A participant was in remission based on US7: if US7 synovitis sum score in GSUS =0, PDUS =0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions (synovitis) and destructive processes (erosions) in a single scoring system. US7 score included MKUS examination of the following joints of the more clinically affected side: wrist, MCP II and III, PIP II and III, MTP II and V. The joints were examined by GSUS and PDUS for synovitis. Synovitis in GSUS and PDUS was analyzed on a scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of the intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on a binary basis 0 and 1 where 0=no remission and remission=1.

Time frame: Month 6 and 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1 and PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition).

Time frame: Month 3, 6, 9 and 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention).

The ACR/EULAR Boolean-based remission rate measured the severity of disease. A participant was considered as having achieved the Boolean-based ACR/EULAR remission at a visit if all of the following 4 criteria were met at that visit: TJC (in 28 joints) \<=1; SJC (in 28 joints) \<=1; CRP\<=1 mg/dl; PGA\<=1 (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition).

Time frame: Month 3, 6, 9 and 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

Remission based on DAS28 + US7: DAS28 \<2.6 and US7 synovitis sum score in GSUS=0, PDUS=0 and US7 erosion sum score in GSUS=0. DAS28: SJC + TJC in 28 joints count + CRP(mg/L) or ESR(mm/hr) levels and PGA on 0-100 mm scale (0 mm \[very well\] to 100 mm \[extremely bad\], higher scores indicated worst health condition). U7 Remission: US7 synovitis sum score in GSUS=0, PDUS=0 and erosion sum score in GSUS=0. US7 score is MKUS composite scoring system which combined soft tissue lesions(synovitis) and destructive processes(erosions) in single scoring system. US7 score included MKUS examination of given joints: wrist, MCP II and III, PIP II and III, MTP II and V. Joints were examined by GSUS and PDUS for synovitis on scale of 0-3 (GSUS: 0=no synovitis, 3=severe synovitis; higher score=more synovitis); (PDUS: 0=no intraarticular color signal, 3 = \>=50% of intraarticular area filled with color signals). Erosions in GSUS and PDUS were calculated on binary basis 0 (no remission) and 1 (remission).

Time frame: Month 6 and 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.

The SDAI was the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, EGA and PGA (assessed on a 0 mm \[very well\] to 10 mm \[extremely bad\] scale; higher scores indicated worst health condition) and CRP (mg/dL). SDAI total score ranged from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. SDAI \>3.4 to 11 implied low disease activity, \>11 to 26 implied moderate disease activity, \>26 implied high disease activity and \<=3.3 implied disease remission.

Time frame: Month 3, 6, 9 and 12

Population: The CAS consisted of all participants enrolled in the study and who completed the 12-month study, whether or not they missed some follow-up visits and regardless of the cohort (first or second intention). Here, N signifies those participants who were evaluable for this specified outcome measure.