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Study With Etanercept Focusing on Remission and Predictability of Remission in Real Life Clinical Practice (REACH RA)

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ClinicalTrials.gov Identifier: NCT02202837
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : December 3, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Rheumatoid Arthritis
Intervention Drug: etanercept
Enrollment 157
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description Participants with rheumatoid arthritis (RA) who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on Summary of Product Characteristics (SmPC). Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Period Title: Overall Study
Started 140 17
Completed 87 12
Not Completed 53 5
Reason Not Completed
Enbrel treatment discontinued             36             4
Other             10             0
Lost to Follow-up             7             1
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention Total
Hide Arm/Group Description Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC. Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC. Total of all reporting groups
Overall Number of Baseline Participants 140 17 157
Hide Baseline Analysis Population Description
The baseline analysis set (BAS) consisted of all participants enrolled in the study who were seen at baseline, whether from first or second cohort.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants 17 participants 157 participants
56.21  (13.55) 56.16  (11.63) 56.21  (13.32)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants 17 participants 157 participants
Female
93
  66.4%
11
  64.7%
104
  66.2%
Male
47
  33.6%
6
  35.3%
53
  33.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 76 10
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
43.4
(32.1 to 55.3)
30.0
(6.67 to 65.3)
2.Primary Outcome
Title Percentage of Participants With Simplified Disease Activity Index (SDAI) Less Than or Equal to (<=) 3.3 at Month 6 and Maintained Till Month 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 73 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
13.7
(6.77 to 23.8)
22.2
(2.81 to 60.0)
3.Primary Outcome
Title Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 6 and Maintained Till Month 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 78 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
3.85
(0.80 to 10.8)
18.2
(2.28 to 51.8)
4.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 74 9
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
2.70
(0.33 to 9.42)
0
(0 to 33.6)
5.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 79 11
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
11.4
(5.34 to 20.5)
18.2
(2.28 to 51.8)
6.Primary Outcome
Title Percentage of Participants With Remission Based on Seven-Joint Ultrasound (US7) Measurements at Month 6 and Maintained Till Month 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 70.8)
0
(0 to 84.2)
7.Primary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 70.8)
0
(0 to 84.2)
8.Secondary Outcome
Title Percentage of Participants With Disease Activity Score Based on 28-Joints Count (DAS28) <2.6 at Month 3, 6, 9 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 86 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 3 Number Analyzed 56 participants 9 participants
50.0
(36.3 to 63.7)
33.3
(7.49 to 70.1)
Month 6 Number Analyzed 76 participants 10 participants
56.6
(44.7 to 67.9)
60.0
(26.2 to 87.8)
Month 9 Number Analyzed 53 participants 7 participants
50.9
(36.8 to 64.9)
28.6
(3.67 to 71.0)
Month 12 Number Analyzed 76 participants 10 participants
51.3
(39.6 to 63.0)
40.0
(12.2 to 73.8)
9.Secondary Outcome
Title Percentage of Participants With Simplified Disease Activity Index (SDAI) <=3.3 at Month 3, 6, 9 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 84 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 3 Number Analyzed 55 participants 8 participants
12.7
(5.27 to 24.5)
12.5
(0.32 to 52.7)
Month 6 Number Analyzed 73 participants 9 participants
19.2
(10.9 to 30.1)
44.4
(13.7 to 78.8)
Month 9 Number Analyzed 50 participants 7 participants
28.0
(16.2 to 42.5)
14.3
(0.36 to 57.9)
Month 12 Number Analyzed 69 participants 9 participants
17.4
(9.32 to 28.4)
11.1
(0.28 to 48.3)
10.Secondary Outcome
Title Percentage of Participants With Clinical Disease Activity Index (CDAI) <=2.8 at Month 3, 6, 9 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 86 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 3 Number Analyzed 65 participants 11 participants
12.3
(5.47 to 22.8)
18.2
(2.28 to 51.8)
Month 6 Number Analyzed 78 participants 11 participants
7.69
(2.88 to 16.0)
36.4
(10.9 to 69.2)
Month 9 Number Analyzed 56 participants 8 participants
23.2
(13.0 to 36.4)
0.00
(0.00 to 36.9)
Month 12 Number Analyzed 75 participants 10 participants
14.7
(7.56 to 24.7)
10.0
(0.25 to 44.5)
11.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 85 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 3 Number Analyzed 56 participants 9 participants
5.36
(1.12 to 14.9)
11.1
(0.28 to 48.3)
Month 6 Number Analyzed 74 participants 9 participants
6.76
(2.23 to 15.1)
11.1
(0.28 to 48.3)
Month 9 Number Analyzed 51 participants 7 participants
5.88
(1.23 to 16.2)
0.00
(0.00 to 41.0)
Month 12 Number Analyzed 73 participants 10 participants
9.59
(3.94 to 18.8)
0.00
(0.00 to 30.9)
12.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 87 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 3 Number Analyzed 66 participants 12 participants
10.6
(4.37 to 20.6)
16.7
(2.09 to 48.4)
Month 6 Number Analyzed 79 participants 11 participants
16.5
(9.06 to 26.5)
45.5
(16.8 to 76.6)
Month 9 Number Analyzed 57 participants 8 participants
26.3
(15.5 to 39.7)
25.0
(3.19 to 65.1)
Month 12 Number Analyzed 80 participants 11 participants
18.8
(10.9 to 29.0)
18.2
(2.28 to 51.8)
13.Secondary Outcome
Title Percentage of Participants With no Signs of Ultrasound Synovitis (Ultrasound Remission) at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 6
0.00
(0.00 to 70.8)
0.00
(0.00 to 70.8)
Month 12
0.00
(0.00 to 70.8)
0.00
(0.00 to 70.8)
14.Secondary Outcome
Title 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
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 3 2
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
Month 6
0.00
(0.00 to 70.8)
0.00
(0.00 to 84.2)
Month 12
0.00
(0.00 to 70.8)
0.00
(0.00 to 84.2)
15.Secondary Outcome
Title Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 86 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 86 participants 12 participants
5.06  (1.15) 5.32  (1.44)
Change at Month 6 Number Analyzed 76 participants 10 participants
2.39  (1.21) 1.92  (2.27)
Change at Month 12 Number Analyzed 75 participants 10 participants
2.36  (1.29) 1.37  (1.01)
16.Secondary Outcome
Title Change From Baseline in Simplified Disease Activity Index (SDAI) at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 84 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 84 participants 12 participants
32.2  (13.67) 35.83  (19.86)
Change at Month 6 Number Analyzed 73 participants 9 participants
21.06  (11.17) 19.62  (18.80)
Change at Month 12 Number Analyzed 68 participants 9 participants
20.30  (12.49) 12.10  (8.29)
17.Secondary Outcome
Title Change From Baseline in Clinical Disease Activity Index (CDAI) at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 86 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 86 participants 12 participants
31.12  (13.15) 34.17  (18.96)
Change at Month 6 Number Analyzed 78 participants 11 participants
20.06  (10.46) 15.64  (16.64)
Change at Month 12 Number Analyzed 75 participants 10 participants
18.85  (13.04) 13.20  (11.71)
18.Secondary Outcome
Title Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 4 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 4 participants 2 participants
6.21  (2.67) 9.50  (2.12)
Change at Month 6 Number Analyzed 3 participants 2 participants
3.24  (3.95) 8.36  (2.32)
Change at Month 12 Number Analyzed 3 participants 2 participants
3.24  (4.20) 3.00  (1.41)
19.Secondary Outcome
Title Change From Baseline in Seven-Joint Ultrasound (US7) Synovitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.90  (3.76) 6.50  (7.78)
Change at Month 6 6.29  (3.87) 5.85  (8.70)
Change at Month 12 6.90  (2.81) 0.50  (3.54)
20.Secondary Outcome
Title Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 3 participants 1 participants
2.00  (2.65) 0.00
Change at Month 6 Number Analyzed 2 participants 1 participants
0.50  (0.71) 0.00
Change at Month 12 Number Analyzed 2 participants 1 participants
0.50  (0.71) 0.00
21.Secondary Outcome
Title Change From Baseline in Seven-Joint Ultrasound (US7) Tenosynovitis/Paratenonitis Power Doppler Ultrasonography (PDUS) Score at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Number Analyzed 3 participants 1 participants
0.67  (1.15) 0.00
Change at Month 6 Number Analyzed 2 participants 1 participants
1.00  (1.41) 0.00
Change at Month 12 Number Analyzed 2 participants 1 participants
1.00  (1.41) 0.00
22.Secondary Outcome
Title Change From Baseline in Seven-Joint Ultrasound (US7) Erosion Grey-Scale Ultrasonography (GSUS) Score at Month 6 and 12
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description:
Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.67  (0.58) 5.00  (1.41)
Change at Month 6 0.33  (0.58) 1.50  (2.12)
Change at Month 12 0.33  (0.58) 0.50  (0.71)
Time Frame From Day 1 up to 28 days after end of treatment (12 months)
Adverse Event Reporting Description Same event may appear as AE and serious AE, what is presented are distinct events. Event may be categorized as serious in 1 participant and as non-serious in another participant or 1 participant may have experienced both serious and non-serious event during study.
 
Arm/Group Title Etanercept: First Intention Etanercept: Second Intention
Hide Arm/Group Description Participants with RA who received Etanercept as their first biological product, according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC. Participants with RA who received Etanercept as second biological product (either after use of another anti-TNF or another mechanism of action), according to prevailing reimbursement criteria in Belgium were observed prospectively for 12 months. The dose and frequency of drug was decided by physician based on SmPC.
All-Cause Mortality
Etanercept: First Intention Etanercept: Second Intention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/140 (0.00%)   0/17 (0.00%) 
Hide Serious Adverse Events
Etanercept: First Intention Etanercept: Second Intention
Affected / at Risk (%) Affected / at Risk (%)
Total   5/140 (3.57%)   2/17 (11.76%) 
Cardiac disorders     
Acute myocardial infarction * 1  0/140 (0.00%)  1/17 (5.88%) 
General disorders     
Fatigue * 1  1/140 (0.71%)  0/17 (0.00%) 
Pain Chest * 1  1/140 (0.71%)  0/17 (0.00%) 
Infections and infestations     
Diverticulitis * 1  1/140 (0.71%)  0/17 (0.00%) 
Metabolism and nutrition disorders     
Decreased appetite * 1  1/140 (0.71%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis * 1  1/140 (0.71%)  0/17 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma * 1 [1]  1/140 (0.71%)  0/17 (0.00%) 
Nervous system disorders     
Carotid artery stenosis * 1  0/140 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders     
Dermal cyst * 1  1/140 (0.71%)  0/17 (0.00%) 
Night sweats * 1  1/140 (0.71%)  0/17 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
[1]
This event is a gender specific event.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Etanercept: First Intention Etanercept: Second Intention
Affected / at Risk (%) Affected / at Risk (%)
Total   51/140 (36.43%)   6/17 (35.29%) 
Blood and lymphatic system disorders     
Leukopenia * 1  1/140 (0.71%)  0/17 (0.00%) 
Lymphadenopathy * 1  1/140 (0.71%)  0/17 (0.00%) 
Thrombocytopenia * 1  1/140 (0.71%)  0/17 (0.00%) 
Cardiac disorders     
Angina Pectoris * 1  1/140 (0.71%)  0/17 (0.00%) 
Cardiac disorder * 1  1/140 (0.71%)  0/17 (0.00%) 
Eye disorders     
Dry eye * 1  1/140 (0.71%)  0/17 (0.00%) 
Eye Irritation * 1  1/140 (0.71%)  0/17 (0.00%) 
Visual impairment * 1  1/140 (0.71%)  0/17 (0.00%) 
Gastrointestinal disorders     
Abdominal pain upper * 1  1/140 (0.71%)  0/17 (0.00%) 
Diarrhea * 1  1/140 (0.71%)  0/17 (0.00%) 
Dry Mouth * 1  0/140 (0.00%)  1/17 (5.88%) 
Nausea * 1  2/140 (1.43%)  0/17 (0.00%) 
General disorders     
Asthenia * 1  0/140 (0.00%)  1/17 (5.88%) 
Fatigue * 1  2/140 (1.43%)  0/17 (0.00%) 
Injection site reaction * 1  1/140 (0.71%)  0/17 (0.00%) 
Injection site erythema * 1  2/140 (1.43%)  1/17 (5.88%) 
Injection site pruritus * 1  0/140 (0.00%)  1/17 (5.88%) 
Injection site hypersensitivity * 1  7/140 (5.00%)  2/17 (11.76%) 
Injection site pain * 1  1/140 (0.71%)  0/17 (0.00%) 
Oedema * 1  1/140 (0.71%)  0/17 (0.00%) 
Oedema peripheral * 1  1/140 (0.71%)  0/17 (0.00%) 
Immune system disorders     
Hypersensitivity * 1  5/140 (3.57%)  0/17 (0.00%) 
Infections and infestations     
Acute sinusitis * 1  1/140 (0.71%)  0/17 (0.00%) 
Body tinea * 1  1/140 (0.71%)  0/17 (0.00%) 
Bronchitis * 1  2/140 (1.43%)  0/17 (0.00%) 
Chlamydial infection * 1  1/140 (0.71%)  0/17 (0.00%) 
Gingivitis * 1  1/140 (0.71%)  0/17 (0.00%) 
Influenza * 1  2/140 (1.43%)  0/17 (0.00%) 
Oral herpes * 1  1/140 (0.71%)  1/17 (5.88%) 
Pharyngitis * 1  1/140 (0.71%)  0/17 (0.00%) 
Pneumonia * 1  1/140 (0.71%)  0/17 (0.00%) 
Respiratory tract infection * 1  2/140 (1.43%)  0/17 (0.00%) 
Rhinitis * 1  1/140 (0.71%)  0/17 (0.00%) 
Sinusitis * 1  1/140 (0.71%)  1/17 (5.88%) 
Upper respiratory tract infection * 1  2/140 (1.43%)  0/17 (0.00%) 
Urinary tract infection * 1  1/140 (0.71%)  0/17 (0.00%) 
Viral pharyngitis * 1  1/140 (0.71%)  0/17 (0.00%) 
Investigations     
Liver function test abnormal * 1  1/140 (0.71%)  0/17 (0.00%) 
Platelet count decreased * 1  1/140 (0.71%)  0/17 (0.00%) 
Weight decreased * 1  1/140 (0.71%)  0/17 (0.00%) 
White blood cell count decreased * 1  1/140 (0.71%)  0/17 (0.00%) 
Musculoskeletal and connective tissue disorders     
Periarthritis * 1  1/140 (0.71%)  0/17 (0.00%) 
Sjogren's syndrome * 1  1/140 (0.71%)  0/17 (0.00%) 
Tendonitis * 1  0/140 (0.00%)  1/17 (5.88%) 
Nervous system disorders     
Carpal tunnel syndrome * 1  3/140 (2.14%)  0/17 (0.00%) 
Dysgeusia * 1  1/140 (0.71%)  0/17 (0.00%) 
Headache * 1  1/140 (0.71%)  1/17 (5.88%) 
Paresthesia * 1  3/140 (2.14%)  0/17 (0.00%) 
Polyneuropathy * 1  1/140 (0.71%)  0/17 (0.00%) 
Syncope * 1  1/140 (0.71%)  0/17 (0.00%) 
Psychiatric disorders     
Depressive mood * 1  1/140 (0.71%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnea * 1  1/140 (0.71%)  1/17 (5.88%) 
Respiratory disorder * 1  1/140 (0.71%)  0/17 (0.00%) 
Skin and subcutaneous tissue disorders     
Alopecia * 1  2/140 (1.43%)  0/17 (0.00%) 
Dermatitis allergic * 1  3/140 (2.14%)  0/17 (0.00%) 
Eczema * 1  1/140 (0.71%)  0/17 (0.00%) 
Hyperkeratosis * 1  1/140 (0.71%)  0/17 (0.00%) 
Pruritus * 1  3/140 (2.14%)  0/17 (0.00%) 
Skin Irritation * 1  1/140 (0.71%)  0/17 (0.00%) 
Rash * 1  4/140 (2.86%)  0/17 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02202837    
Other Study ID Numbers: B1801378
B1801378 ( Other Identifier: Alias Study Number )
REACH-RA ( Other Identifier: Alias Study Number )
First Submitted: July 15, 2014
First Posted: July 29, 2014
Results First Submitted: April 23, 2018
Results First Posted: December 3, 2018
Last Update Posted: December 3, 2018