Trial Outcomes & Findings for Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (NCT NCT01756235)
NCT ID: NCT01756235
Last Updated: 2017-03-06
Results Overview
The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.
Recruitment status
COMPLETED
Target enrollment
462 participants
Primary outcome timeframe
Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))
Results posted on
2017-03-06
Participant Flow
A total of 462 participants were enrolled: 460 were in the main analysis set (MAS) population; 2 were excluded from MAS, as adalimumab treatment was not documented within this study.
Participant milestones
| Measure |
Participants With Rheumatoid Arthritis
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Overall Study
STARTED
|
462
|
|
Overall Study
COMPLETED
|
460
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Participants With Rheumatoid Arthritis
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|---|---|
|
Overall Study
Adalimumab Treatment was not Documented
|
2
|
Baseline Characteristics
Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice
Baseline characteristics by cohort
| Measure |
Participants With Rheumatoid Arthritis
n=460 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Age, Continuous
|
53.9 years
STANDARD_DEVIATION 12.1 • n=5 Participants
|
|
Gender
Female
|
378 Participants
n=5 Participants
|
|
Gender
Male
|
82 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=374 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score
|
870.0 units on a scale
Standard Deviation 4517.8
|
SECONDARY outcome
Timeframe: Month 3, Month 6 and Month 9Population: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=356 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Total Physical Activity SQUASH Score
Month 3 (N=356)
|
454.9 units on a scale
Standard Deviation 3553.9
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Score
Month 6 (N=316)
|
648.2 units on a scale
Standard Deviation 3565.1
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Score
Month 9 (N=273)
|
611.3 units on a scale
Standard Deviation 4130.4
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
SQUASH subscores capture physical activity. SQUASH-A subscore captures commuting activities, with scores ranging from 0 to 4082.400. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=382 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in SQUASH-A Scores
Month 3 (N=368)
|
-91.6 units on a scale
Standard Deviation 950.2
|
|
Mean Change From Baseline in SQUASH-A Scores
Month 6 (N=327)
|
-41.7 units on a scale
Standard Deviation 957.4
|
|
Mean Change From Baseline in SQUASH-A Scores
Month 9 (N=281)
|
3.5 units on a scale
Standard Deviation 1052.4
|
|
Mean Change From Baseline in SQUASH-A Scores
Month 12 (N=265)
|
10.4 units on a scale
Standard Deviation 880.4
|
|
Mean Change From Baseline in SQUASH-A Scores
Month 12 LOCF (N=382)
|
-35.7 units on a scale
Standard Deviation 1043.2
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
SQUASH subscores capture physical activity. SQUASH-B subscore captures leisure time activities, with scores ranging from 0 to 6123.600. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=375 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in SQUASH-B Scores
Month 3 (N=359)
|
399.5 units on a scale
Standard Deviation 2729.2
|
|
Mean Change From Baseline in SQUASH-B Scores
Month 6 (N=319)
|
497.9 units on a scale
Standard Deviation 2375
|
|
Mean Change From Baseline in SQUASH-B Scores
Month 9 (N=277)
|
358.9 units on a scale
Standard Deviation 2720.5
|
|
Mean Change From Baseline in SQUASH-B Scores
Month 12 (N=257)
|
831.3 units on a scale
Standard Deviation 3450.7
|
|
Mean Change From Baseline in SQUASH-B Scores
Month 12 LOCF (N=375)
|
578.0 units on a scale
Standard Deviation 3131.1
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
SQUASH subscores capture physical activity. SQUASH-C subscore captures house-hold activities, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=379 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in SQUASH-C Scores
Month 6 (N=325)
|
154.6 units on a scale
Standard Deviation 1516.5
|
|
Mean Change From Baseline in SQUASH-C Scores
Month 3 (N=364)
|
81.4 units on a scale
Standard Deviation 1507.5
|
|
Mean Change From Baseline in SQUASH-C Scores
Month 9 (N=281)
|
98.5 units on a scale
Standard Deviation 1590.6
|
|
Mean Change From Baseline in SQUASH-C Scores
Month 12 (N=261)
|
315.4 units on a scale
Standard Deviation 1750
|
|
Mean Change From Baseline in SQUASH-C Scores
Month 12 LOCF (N=379)
|
196.9 units on a scale
Standard Deviation 1725.9
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
SQUASH subscores capture physical activity. SQUASH-D subscore captures activity at work and school, with scores ranging from 0 to 3402.000. The SQUASH subscores have non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=382 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in SQUASH-D Scores
Month 3 (N=370)
|
47.3 units on a scale
Standard Deviation 823.2
|
|
Mean Change From Baseline in SQUASH-D Scores
Month 6 (N=330)
|
27.2 units on a scale
Standard Deviation 1102.3
|
|
Mean Change From Baseline in SQUASH-D Scores
Month 9 (N=284)
|
170.2 units on a scale
Standard Deviation 1263.7
|
|
Mean Change From Baseline in SQUASH-D Scores
Month 12 (N=266)
|
136.2 units on a scale
Standard Deviation 1733.3
|
|
Mean Change From Baseline in SQUASH-D Scores
Month 12 LOCF (N=382)
|
96.4 units on a scale
Standard Deviation 1536.8
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein, and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=433 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score
Month 3 (N=431)
|
-2.4 units on a scale
Standard Deviation 1.4
|
|
Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score
Month 6 (N=390)
|
-2.8 units on a scale
Standard Deviation 1.5
|
|
Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score
Month 9 (N=362)
|
-3.0 units on a scale
Standard Deviation 1.5
|
|
Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score
Month 12 (N=334)
|
-3.3 units on a scale
Standard Deviation 1.5
|
|
Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score
Month 12 LOCF (N=433)
|
-2.9 units on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Remission is defined as DAS28 of less than 2.6. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=459 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
Month 0 (N=459)
|
0.7 percentage of participants
|
|
Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
Month 3 (N=432)
|
21.3 percentage of participants
|
|
Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
Month 6 (N=390)
|
30.3 percentage of participants
|
|
Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
Month 9 (N=362)
|
32.3 percentage of participants
|
|
Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
Month 12 (N=334)
|
37.4 percentage of participants
|
|
Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
Month 12 LOCF (N=434)
|
31.1 percentage of participants
|
SECONDARY outcome
Timeframe: Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
LDAS is defined as DAS28 of less than 3.2. The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=459 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
Month 0 (N=459)
|
1.3 percentage of participants
|
|
Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
Month 3 (N=432)
|
35.4 percentage of participants
|
|
Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
Month 6 (N=390)
|
46.4 percentage of participants
|
|
Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
Month 9 (N=362)
|
54.4 percentage of participants
|
|
Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
Month 12 (N=334)
|
66.2 percentage of participants
|
|
Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
Month 12 LOCF (N=434)
|
56.0 percentage of participants
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=214 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH (Month 3, N=198)
|
473.3 units on a scale
Standard Deviation 3417.8
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-A (Month 3, N=204)
|
-57.5 units on a scale
Standard Deviation 609.4
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-B (Month 3, N=200)
|
438.3 units on a scale
Standard Deviation 2480.6
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-C (Month 3, N=200)
|
87.0 units on a scale
Standard Deviation 1617.6
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-D (Month 3, N=205)
|
-11.3 units on a scale
Standard Deviation 762.1
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH (Month 6, N=181)
|
979.8 units on a scale
Standard Deviation 3567.4
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-A (Month 6, N=187)
|
-23.2 units on a scale
Standard Deviation 724.8
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-B (Month 6, N=183)
|
761.0 units on a scale
Standard Deviation 2383.3
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-C (Month 6, N=186)
|
234.5 units on a scale
Standard Deviation 1518.8
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-D (Month 6, N=189)
|
-8.6 units on a scale
Standard Deviation 1142.7
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH (Month 9, N=162)
|
1209.8 units on a scale
Standard Deviation 4126.9
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-A (Month 9, N=165)
|
130.3 units on a scale
Standard Deviation 874.0
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-B (Month 9, N=164)
|
707.2 units on a scale
Standard Deviation 2815.5
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-C (Month 9, N=165)
|
255.9 units on a scale
Standard Deviation 1713.8
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-D (Month 9, N=167)
|
142.4 units on a scale
Standard Deviation 1298.6
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH (Month 12, N=167)
|
1912.4 units on a scale
Standard Deviation 4592.1
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-A (Month 12, N=171)
|
80.7 units on a scale
Standard Deviation 724.8
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-B (Month 12, N=167)
|
1158.7 units on a scale
Standard Deviation 3168.1
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-C (Month 12, N=169)
|
470.7 units on a scale
Standard Deviation 1898.4
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-D (Month 12, N=171)
|
171.6 units on a scale
Standard Deviation 1905.4
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH (Month 12 LOCF, N=211)
|
1494.8 units on a scale
Standard Deviation 4513.8
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-A (Month 12 LOCF, N=214)
|
53.4 units on a scale
Standard Deviation 860.0
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-B (Month 12 LOCF, N=211)
|
964.5 units on a scale
Standard Deviation 3127.4
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-C (Month 12 LOCF, N=212)
|
367.5 units on a scale
Standard Deviation 1808.5
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS
SQUASH-D (Month 12 LOCF, N=214)
|
90.0 units on a scale
Standard Deviation 1778.7
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
This outcome analyses the quantitative SQUASH score and individual SQUASH scores by DAS28 categories. The quantitative SQUASH score (ranging from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), leisure time activities (SQUASH-B), household activities (SQUASH-C) and activity at work and school (SQUASH-D). The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level. DAS28 categories being assessed are remission (defined as DAS28 of less than 2.6) and LDAS (defined as DAS28 of less than 3.2).The DAS28 is a validated index of rheumatoid arthritis disease activity. Tender joint counts and swollen joint counts across 28 joints, C-reactive protein (CRP), and general health assessed via the visual analog scale (VAS) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher scores indicating higher disease activity.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=167 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH (Month 3, N=157)
|
434.5 units on a scale
Standard Deviation 3739.9
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-A (Month 3, N=163)
|
-134.8 units on a scale
Standard Deviation 1255.7
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-B (Month 3, N=158)
|
352.9 units on a scale
Standard Deviation 3029.8
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-C (Month 3, N=163)
|
75.1 units on a scale
Standard Deviation 1370.3
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-D (Month 3, N=164)
|
120.7 units on a scale
Standard Deviation 893.0
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH (Month 6, N=135)
|
203.6 units on a scale
Standard Deviation 3526.4
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-A (Month 6, N=140)
|
-66.5 units on a scale
Standard Deviation 1202.3
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-B (Month 6, N=136)
|
143.9 units on a scale
Standard Deviation 2325.7
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-C (Month 6, N=139)
|
47.6 units on a scale
Standard Deviation 1512.2
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-D (Month 6, N=141)
|
75.1 units on a scale
Standard Deviation 1047.9
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH (Month 9, N=111)
|
-262.1 units on a scale
Standard Deviation 3995.1
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-A (Month 9, N=116)
|
-176.9 units on a scale
Standard Deviation 1245.6
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-B (Month 9, N=113)
|
-146.6 units on a scale
Standard Deviation 2503.3
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-C (Month 9, N=116)
|
-125.5 units on a scale
Standard Deviation 1373.1
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-D (Month 9, N=117)
|
209.8 units on a scale
Standard Deviation 1216.5
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH (Month 12, N=88)
|
230.7 units on a scale
Standard Deviation 4924.9
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-A (Month 12, N=94)
|
-117.6 units on a scale
Standard Deviation 1102.0
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-B (Month 12, N=90)
|
223.9 units on a scale
Standard Deviation 3867.2
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-C (Month 12, N=92)
|
30.1 units on a scale
Standard Deviation 1403.4
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-D (Month 12, N=95)
|
72.4 units on a scale
Standard Deviation 1377.4
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH (Month 12 LOCF, N=162)
|
61.6 units on a scale
Standard Deviation 4420.2
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-A (Month 12 LOCF, N=167)
|
-150.2 units on a scale
Standard Deviation 1235.1
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-B (Month 12 LOCF, N=163)
|
81.3 units on a scale
Standard Deviation 3083.7
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-C (Month 12 LOCF, N=166)
|
-19.8 units on a scale
Standard Deviation 1599.0
|
|
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS
SQUASH-D (Month 12 LOCF, N=167)
|
105.1 units on a scale
Standard Deviation 1166.4
|
SECONDARY outcome
Timeframe: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores range from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the overall score indicates improvement.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=396 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Month 3 (N=384)
|
-0.5 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Month 6 (N=345)
|
-0.7 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Month 9 (N=300)
|
-0.8 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Month 12 (N=284)
|
-0.9 units on a scale
Standard Deviation 0.6
|
|
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Month 12 LOCF (N=396)
|
-0.7 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: Month 0 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The SQUASH and its subscores are instruments to measure the physical activity level, whereas the DAS28 measures disease activity. In order to evaluate the relationship between physical function and disease activity (as measured by the two scales), Pearson correlation coefficients were calculated for the SQUASH scores and the DAS28. A decrease in physical functioning is likely to be connected to stronger disease activity.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=432 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH and DAS28 (Month 0, N=423)
|
-0.19 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH and DAS28 (Month 12 LOCF, N=386)
|
-0.21 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH-A and DAS28 (Month 0, N=431)
|
-0.06 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH-A and DAS28 (Month 12 LOCF, N=386)
|
-0.07 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH-B and DAS28 (Month 0, N=424)
|
-0.10 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH-B and DAS28 (Month 12 LOCF, N=386)
|
-0.17 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH-C and DAS28 (Month 0, N=429)
|
-0.19 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH-C and DAS28 (Month 12 LOCF, N=386)
|
-0.15 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH-D and DAS28 (Month 0, N=432)
|
-0.09 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores
SQUASH-D and DAS28 (Month 12 LOCF, N=386)
|
-0.08 Correlation coeficient
|
SECONDARY outcome
Timeframe: Month 0 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The SQUASH and its subscores are instruments to measure the physical activity level, whereas the HAQ-DI measures physical functioning. In order to evaluate the relationship between physical function and physical activity (as measured by the both scales), Pearson correlation coefficients were calculated for the SQUASH scores and the HAQ-DI. A decrease in physical functioning is likely to prohibit physical activity.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=430 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH (Month 0, N=421)
|
-0.30 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH (Month 12 LOCF, N=385)
|
-0.22 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH-A (Month 0, N=429)
|
-0.16 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH-A (Month 12 LOCF, N=385)
|
-0.11 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH-B (Month 0, N=422)
|
-0.21 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH-B (Month 12 LOCF, N=385)
|
-0.19 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH-C (Month 0, N=427)
|
-0.20 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH-C (Month 12 LOCF, N=385)
|
-0.10 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH-D (Month 0, N=430)
|
-0.14 Correlation coeficient
|
|
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
SQUASH-D (Month 12 LOCF, N=385)
|
-0.10 Correlation coeficient
|
SECONDARY outcome
Timeframe: Month 0 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=382 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH (<65 years, N=297)
|
1066.2 units on a scale
Standard Deviation 4456.6
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH (>=65 years, N=77)
|
113.1 units on a scale
Standard Deviation 4699.9
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH A (<65 years, N=302)
|
-27.5 units on a scale
Standard Deviation 1066.4
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH A (>=65 years, N=80)
|
-66.7 units on a scale
Standard Deviation 956.4
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH B (<65 years, N=298)
|
770.8 units on a scale
Standard Deviation 2850.4
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH B (>=65 years, N=77)
|
-167.8 units on a scale
Standard Deviation 3972.9
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH C (<65 years, N=300)
|
189.5 units on a scale
Standard Deviation 1779.6
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH C (>=65 years, N=79)
|
225.0 units on a scale
Standard Deviation 1514.7
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH D (<65 years, N=302)
|
103.8 units on a scale
Standard Deviation 1691.5
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories
SQUASH D (>=65 years, N=80)
|
68.3 units on a scale
Standard Deviation 697.8
|
SECONDARY outcome
Timeframe: Month 0 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=382 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH (Male, N=70)
|
1500.1 units on a scale
Standard Deviation 5026.2
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH (Female, N=304)
|
724.9 units on a scale
Standard Deviation 4388.7
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH-A (Male, N=70)
|
-133.9 units on a scale
Standard Deviation 1091.0
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH-A (Female, N=312)
|
-13.7 units on a scale
Standard Deviation 1032.8
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH-B (Male, N=70)
|
948.3 units on a scale
Standard Deviation 3565.2
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH-B (Female, N=305)
|
493.0 units on a scale
Standard Deviation 3022.8
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH-C (Male, N=70)
|
344.7 units on a scale
Standard Deviation 1774.0
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH-C (Female, N=309)
|
163.4 units on a scale
Standard Deviation 1716.0
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH-D (Male, N=70)
|
264.6 units on a scale
Standard Deviation 1719.8
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender
SQUASH-D (Female, N=312)
|
58.6 units on a scale
Standard Deviation 1493.0
|
SECONDARY outcome
Timeframe: Month 0 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=382 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH (High School, N=195)
|
831.7 units on a scale
Standard Deviation 3946.1
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH (Lower than High School, N=179)
|
911.8 units on a scale
Standard Deviation 5079.0
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH-A (High School, N=198)
|
-45.2 units on a scale
Standard Deviation 926.9
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH-A (Lower than High School, N=184)
|
-25.5 units on a scale
Standard Deviation 1158.0
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH-B (High School, N=195)
|
520.5 units on a scale
Standard Deviation 2187.4
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH-B (Lower than High School, N=180)
|
640.4 units on a scale
Standard Deviation 3910.3
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH-C (High School, N=198)
|
202.1 units on a scale
Standard Deviation 1751.3
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH-C (Lower than High School, N=181)
|
191.2 units on a scale
Standard Deviation 1702.5
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH-D (High School, N=198)
|
131.4 units on a scale
Standard Deviation 1644.3
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education
SQUASH-D (Lower than High School, N=184)
|
58.7 units on a scale
Standard Deviation 1415.5
|
SECONDARY outcome
Timeframe: Month 0 and Month 12 LOCFPopulation: Analysis included all participants who received at least one dose of adalimumab with evaluable data.
The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.
Outcome measures
| Measure |
Participants With Rheumatoid Arthritis
n=381 Participants
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH (Manual job, N=184)
|
1235.3 units on a scale
Standard Deviation 4853.6
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH (Non-manual job, N=189)
|
518.4 units on a scale
Standard Deviation 4160.2
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH-A (Manual job, N=188)
|
62.2 units on a scale
Standard Deviation 977.3
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH-A (Non-manual job, N=193)
|
-131.3 units on a scale
Standard Deviation 1100.4
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH-B (Manual job, N=185)
|
614.5 units on a scale
Standard Deviation 3452.2
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH-B (Non-manual job, N=189)
|
544.1 units on a scale
Standard Deviation 2799.3
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH-C (Manual job, N=186)
|
456.6 units on a scale
Standard Deviation 1875.8
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH-C (Non-manual job, N=192)
|
-53.0 units on a scale
Standard Deviation 1535.6
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH-D (Manual job, N=188)
|
40.1 units on a scale
Standard Deviation 1486.4
|
|
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation
SQUASH-D (Non-manual job, N=193)
|
151.7 units on a scale
Standard Deviation 1590.1
|
Adverse Events
Participants With Rheumatoid Arthritis
Serious events: 32 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Rheumatoid Arthritis
n=460 participants at risk
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
|
|---|---|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
General disorders
CHEST PAIN
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
General disorders
NO THERAPEUTIC RESPONSE
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Hepatobiliary disorders
CHOLECYSTITIS ACUTE
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.43%
2/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
BRONCHITIS
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
CYTOMEGALOVIRUS HEPATITIS
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
HERPES OPHTHALMIC
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
LOCALISED INFECTION
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
PULMONARY TUBERCULOSIS
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
TONSILLITIS
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Infections and infestations
VAGINAL INFECTION
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
LUPUS-LIKE SYNDROME
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG ADENOCARCINOMA
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Nervous system disorders
INTERCOSTAL NEURALGIA
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Nervous system disorders
ISCHAEMIC STROKE
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.43%
2/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
PHOTODERMATOSIS
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
|
Skin and subcutaneous tissue disorders
SKIN DISORDER
|
0.22%
1/460 • Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 12 months.
Non serious adverse events were not collected for this study.
|
Other adverse events
Adverse event data not reported
Additional Information
Global Medical Information
AbbVie
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- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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Restriction type: OTHER