Defining Which Remission Criterion at Month 6 Predicts Remission at Month 12 in a Real Life Clinical Practice, in a Cohort of Rheumatoid Arthritis Patients Treated with Etanercept
The analysis of the primary endpoint will be based on a logistic regression defining the dependent variable as the remission at Month 12 and the 5 independent variables as CDAI, SDAI, DAS28, DAS28 and Ultrasound, and EULAR Boolean definition for clinical practice and clinical studies. This analysis will be conducted in each arm of the study as well as after a pooling of both patient groups. In this context it seems reasonable to ensure the completion of the study by a total approximate number of 100 patients (approximately 50 patients per arm). In order to ensure 50 completers in each arm, 70 patients will be recruited at baseline, taking into account a drop out rate of 30% over 1 year period.
Study Type
OBSERVATIONAL
Enrollment
157
etanercept 1 x 50 mg/week or 2 x 25mg/week
etanercept 1 x 50 mg/week or 2 x 25mg/week
Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) Less Than (<) 2.6 at Month 6 and Maintained Till Month 12
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
Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12
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
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12
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
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CHU Dinant Godinne
Yvoir, Namur, Belgium
ASZ Aalst
Aalst, Belgium
Algemeen Stedelijk Ziekenhuis
Aalst, Belgium
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, Belgium
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium
St. Lucas ZH
Assebroeck, Belgium
St-Lucas Ziekenhuis
Assebroek, Belgium
Centre Hospitalier Universitarie Brugmann
Brussels, Belgium
CHIREC
Brussels, Belgium
Private Practice
Champion, Belgium
...and 25 more locations
Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion
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
Percentage of Participants With Remission at Month 6 and Maintained Till Month 12 Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion
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
Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12
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
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Maintained Till Month 12
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
Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12
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
Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12
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
Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12
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
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Studies) Boolean Criterion at Month 3, 6, 9 and 12
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
Percentage of Participants With Remission Based on American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) (Clinical Practice) Boolean Criterion at Month 3, 6, 9 and 12
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
Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12
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
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28) in Combination With Seven-Joint Ultrasound (US7) Measurement at Month 6 and Month 12
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
Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12
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
Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12
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
Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12
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
Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
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
Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
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
Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
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
Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
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
Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
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