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Trial record 32 of 2725 for:    Rheumatoid Arthritis

Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)

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ClinicalTrials.gov Identifier: NCT01756235
Recruitment Status : Completed
First Posted : December 25, 2012
Results First Posted : March 6, 2017
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Observational
Study Design Time Perspective: Prospective
Condition Rheumatoid Arthritis
Enrollment 462
Recruitment Details 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.
Pre-assignment Details  
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice
Period Title: Overall Study
Started 462
Completed 460
Not Completed 2
Reason Not Completed
Adalimumab Treatment was not Documented             2
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Baseline Participants 460
Hide Baseline Analysis Population Description
Baseline analyses accounts for main analysis set (MAS) population (all participants who received at least 1 dose of study drug).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 460 participants
53.9  (12.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 460 participants
Female
378
  82.2%
Male
82
  17.8%
1.Primary Outcome
Title Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score
Hide Description 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.
Time Frame Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 374
Mean (Standard Deviation)
Unit of Measure: units on a scale
870.0  (4517.8)
2.Secondary Outcome
Title Mean Change From Baseline in Total Physical Activity SQUASH Score
Hide Description 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.
Time Frame Month 3, Month 6 and Month 9
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 356
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=356) 454.9  (3553.9)
Month 6 (N=316) 648.2  (3565.1)
Month 9 (N=273) 611.3  (4130.4)
3.Secondary Outcome
Title Mean Change From Baseline in SQUASH-A Scores
Hide Description 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.
Time Frame Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 382
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=368) -91.6  (950.2)
Month 6 (N=327) -41.7  (957.4)
Month 9 (N=281) 3.5  (1052.4)
Month 12 (N=265) 10.4  (880.4)
Month 12 LOCF (N=382) -35.7  (1043.2)
4.Secondary Outcome
Title Mean Change From Baseline in SQUASH-B Scores
Hide Description 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.
Time Frame Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 375
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=359) 399.5  (2729.2)
Month 6 (N=319) 497.9  (2375)
Month 9 (N=277) 358.9  (2720.5)
Month 12 (N=257) 831.3  (3450.7)
Month 12 LOCF (N=375) 578.0  (3131.1)
5.Secondary Outcome
Title Mean Change From Baseline in SQUASH-C Scores
Hide Description 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.
Time Frame Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 379
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=364) 81.4  (1507.5)
Month 6 (N=325) 154.6  (1516.5)
Month 9 (N=281) 98.5  (1590.6)
Month 12 (N=261) 315.4  (1750)
Month 12 LOCF (N=379) 196.9  (1725.9)
6.Secondary Outcome
Title Mean Change From Baseline in SQUASH-D Scores
Hide Description 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.
Time Frame Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 382
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=370) 47.3  (823.2)
Month 6 (N=330) 27.2  (1102.3)
Month 9 (N=284) 170.2  (1263.7)
Month 12 (N=266) 136.2  (1733.3)
Month 12 LOCF (N=382) 96.4  (1536.8)
7.Secondary Outcome
Title Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score
Hide Description 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.
Time Frame Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 433
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=431) -2.4  (1.4)
Month 6 (N=390) -2.8  (1.5)
Month 9 (N=362) -3.0  (1.5)
Month 12 (N=334) -3.3  (1.5)
Month 12 LOCF (N=433) -2.9  (1.7)
8.Secondary Outcome
Title Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
Hide Description 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.
Time Frame Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 459
Measure Type: Number
Unit of Measure: percentage of participants
Month 0 (N=459) 0.7
Month 3 (N=432) 21.3
Month 6 (N=390) 30.3
Month 9 (N=362) 32.3
Month 12 (N=334) 37.4
Month 12 LOCF (N=434) 31.1
9.Secondary Outcome
Title Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
Hide Description 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.
Time Frame Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 459
Measure Type: Number
Unit of Measure: percentage of participants
Month 0 (N=459) 1.3
Month 3 (N=432) 35.4
Month 6 (N=390) 46.4
Month 9 (N=362) 54.4
Month 12 (N=334) 66.2
Month 12 LOCF (N=434) 56.0
10.Secondary Outcome
Title Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories’ SQUASH Scores in Participants in Remission or LDAS
Hide Description 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.
Time Frame Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 214
Mean (Standard Deviation)
Unit of Measure: units on a scale
SQUASH (Month 3, N=198) 473.3  (3417.8)
SQUASH-A (Month 3, N=204) -57.5  (609.4)
SQUASH-B (Month 3, N=200) 438.3  (2480.6)
SQUASH-C (Month 3, N=200) 87.0  (1617.6)
SQUASH-D (Month 3, N=205) -11.3  (762.1)
SQUASH (Month 6, N=181) 979.8  (3567.4)
SQUASH-A (Month 6, N=187) -23.2  (724.8)
SQUASH-B (Month 6, N=183) 761.0  (2383.3)
SQUASH-C (Month 6, N=186) 234.5  (1518.8)
SQUASH-D (Month 6, N=189) -8.6  (1142.7)
SQUASH (Month 9, N=162) 1209.8  (4126.9)
SQUASH-A (Month 9, N=165) 130.3  (874.0)
SQUASH-B (Month 9, N=164) 707.2  (2815.5)
SQUASH-C (Month 9, N=165) 255.9  (1713.8)
SQUASH-D (Month 9, N=167) 142.4  (1298.6)
SQUASH (Month 12, N=167) 1912.4  (4592.1)
SQUASH-A (Month 12, N=171) 80.7  (724.8)
SQUASH-B (Month 12, N=167) 1158.7  (3168.1)
SQUASH-C (Month 12, N=169) 470.7  (1898.4)
SQUASH-D (Month 12, N=171) 171.6  (1905.4)
SQUASH (Month 12 LOCF, N=211) 1494.8  (4513.8)
SQUASH-A (Month 12 LOCF, N=214) 53.4  (860.0)
SQUASH-B (Month 12 LOCF, N=211) 964.5  (3127.4)
SQUASH-C (Month 12 LOCF, N=212) 367.5  (1808.5)
SQUASH-D (Month 12 LOCF, N=214) 90.0  (1778.7)
11.Secondary Outcome
Title 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
Hide Description 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.
Time Frame Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 167
Mean (Standard Deviation)
Unit of Measure: units on a scale
SQUASH (Month 3, N=157) 434.5  (3739.9)
SQUASH-A (Month 3, N=163) -134.8  (1255.7)
SQUASH-B (Month 3, N=158) 352.9  (3029.8)
SQUASH-C (Month 3, N=163) 75.1  (1370.3)
SQUASH-D (Month 3, N=164) 120.7  (893.0)
SQUASH (Month 6, N=135) 203.6  (3526.4)
SQUASH-A (Month 6, N=140) -66.5  (1202.3)
SQUASH-B (Month 6, N=136) 143.9  (2325.7)
SQUASH-C (Month 6, N=139) 47.6  (1512.2)
SQUASH-D (Month 6, N=141) 75.1  (1047.9)
SQUASH (Month 9, N=111) -262.1  (3995.1)
SQUASH-A (Month 9, N=116) -176.9  (1245.6)
SQUASH-B (Month 9, N=113) -146.6  (2503.3)
SQUASH-C (Month 9, N=116) -125.5  (1373.1)
SQUASH-D (Month 9, N=117) 209.8  (1216.5)
SQUASH (Month 12, N=88) 230.7  (4924.9)
SQUASH-A (Month 12, N=94) -117.6  (1102.0)
SQUASH-B (Month 12, N=90) 223.9  (3867.2)
SQUASH-C (Month 12, N=92) 30.1  (1403.4)
SQUASH-D (Month 12, N=95) 72.4  (1377.4)
SQUASH (Month 12 LOCF, N=162) 61.6  (4420.2)
SQUASH-A (Month 12 LOCF, N=167) -150.2  (1235.1)
SQUASH-B (Month 12 LOCF, N=163) 81.3  (3083.7)
SQUASH-C (Month 12 LOCF, N=166) -19.8  (1599.0)
SQUASH-D (Month 12 LOCF, N=167) 105.1  (1166.4)
12.Secondary Outcome
Title Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score
Hide Description 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.
Time Frame Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 396
Mean (Standard Deviation)
Unit of Measure: units on a scale
Month 3 (N=384) -0.5  (0.6)
Month 6 (N=345) -0.7  (0.6)
Month 9 (N=300) -0.8  (0.6)
Month 12 (N=284) -0.9  (0.6)
Month 12 LOCF (N=396) -0.7  (0.7)
13.Secondary Outcome
Title Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) and DAS28 Scores
Hide Description 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.
Time Frame Month 0 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 432
Measure Type: Number
Unit of Measure: Correlation coeficient
SQUASH and DAS28 (Month 0, N=423) -0.19
SQUASH and DAS28 (Month 12 LOCF, N=386) -0.21
SQUASH-A and DAS28 (Month 0, N=431) -0.06
SQUASH-A and DAS28 (Month 12 LOCF, N=386) -0.07
SQUASH-B and DAS28 (Month 0, N=424) -0.10
SQUASH-B and DAS28 (Month 12 LOCF, N=386) -0.17
SQUASH-C and DAS28 (Month 0, N=429) -0.19
SQUASH-C and DAS28 (Month 12 LOCF, N=386) -0.15
SQUASH-D and DAS28 (Month 0, N=432) -0.09
SQUASH-D and DAS28 (Month 12 LOCF, N=386) -0.08
14.Secondary Outcome
Title Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) and HAQ-DI Scores
Hide Description 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.
Time Frame Month 0 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 430
Measure Type: Number
Unit of Measure: Correlation coeficient
SQUASH (Month 0, N=421) -0.30
SQUASH (Month 12 LOCF, N=385) -0.22
SQUASH-A (Month 0, N=429) -0.16
SQUASH-A (Month 12 LOCF, N=385) -0.11
SQUASH-B (Month 0, N=422) -0.21
SQUASH-B (Month 12 LOCF, N=385) -0.19
SQUASH-C (Month 0, N=427) -0.20
SQUASH-C (Month 12 LOCF, N=385) -0.10
SQUASH-D (Month 0, N=430) -0.14
SQUASH-D (Month 12 LOCF, N=385) -0.10
15.Secondary Outcome
Title Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Age Categories
Hide Description 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.
Time Frame Month 0 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 382
Mean (Standard Deviation)
Unit of Measure: units on a scale
SQUASH (<65 years, N=297) 1066.2  (4456.6)
SQUASH (>=65 years, N=77) 113.1  (4699.9)
SQUASH A (<65 years, N=302) -27.5  (1066.4)
SQUASH A (>=65 years, N=80) -66.7  (956.4)
SQUASH B (<65 years, N=298) 770.8  (2850.4)
SQUASH B (>=65 years, N=77) -167.8  (3972.9)
SQUASH C (<65 years, N=300) 189.5  (1779.6)
SQUASH C (>=65 years, N=79) 225.0  (1514.7)
SQUASH D (<65 years, N=302) 103.8  (1691.5)
SQUASH D (>=65 years, N=80) 68.3  (697.8)
16.Secondary Outcome
Title Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Gender
Hide Description 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.
Time Frame Month 0 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 382
Mean (Standard Deviation)
Unit of Measure: units on a scale
SQUASH (Male, N=70) 1500.1  (5026.2)
SQUASH (Female, N=304) 724.9  (4388.7)
SQUASH-A (Male, N=70) -133.9  (1091.0)
SQUASH-A (Female, N=312) -13.7  (1032.8)
SQUASH-B (Male, N=70) 948.3  (3565.2)
SQUASH-B (Female, N=305) 493.0  (3022.8)
SQUASH-C (Male, N=70) 344.7  (1774.0)
SQUASH-C (Female, N=309) 163.4  (1716.0)
SQUASH-D (Male, N=70) 264.6  (1719.8)
SQUASH-D (Female, N=312) 58.6  (1493.0)
17.Secondary Outcome
Title Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Education
Hide Description 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.
Time Frame Month 0 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 382
Mean (Standard Deviation)
Unit of Measure: units on a scale
SQUASH (High School, N=195) 831.7  (3946.1)
SQUASH (Lower than High School, N=179) 911.8  (5079.0)
SQUASH-A (High School, N=198) -45.2  (926.9)
SQUASH-A (Lower than High School, N=184) -25.5  (1158.0)
SQUASH-B (High School, N=195) 520.5  (2187.4)
SQUASH-B (Lower than High School, N=180) 640.4  (3910.3)
SQUASH-C (High School, N=198) 202.1  (1751.3)
SQUASH-C (Lower than High School, N=181) 191.2  (1702.5)
SQUASH-D (High School, N=198) 131.4  (1644.3)
SQUASH-D (Lower than High School, N=184) 58.7  (1415.5)
18.Secondary Outcome
Title Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories’ SQUASH Scores) Influenced by Occupation
Hide Description 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.
Time Frame Month 0 and Month 12 LOCF
Hide Outcome Measure Data
Hide Analysis Population Description
Analysis included all participants who received at least one dose of adalimumab with evaluable data.
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description:
Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
Overall Number of Participants Analyzed 381
Mean (Standard Deviation)
Unit of Measure: units on a scale
SQUASH (Manual job, N=184) 1235.3  (4853.6)
SQUASH (Non-manual job, N=189) 518.4  (4160.2)
SQUASH-A (Manual job, N=188) 62.2  (977.3)
SQUASH-A (Non-manual job, N=193) -131.3  (1100.4)
SQUASH-B (Manual job, N=185) 614.5  (3452.2)
SQUASH-B (Non-manual job, N=189) 544.1  (2799.3)
SQUASH-C (Manual job, N=186) 456.6  (1875.8)
SQUASH-C (Non-manual job, N=192) -53.0  (1535.6)
SQUASH-D (Manual job, N=188) 40.1  (1486.4)
SQUASH-D (Non-manual job, N=193) 151.7  (1590.1)
Time Frame 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.
Adverse Event Reporting Description Non serious adverse events were not collected for this study.
 
Arm/Group Title Participants With Rheumatoid Arthritis
Hide Arm/Group Description Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
All-Cause Mortality
Participants With Rheumatoid Arthritis
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Rheumatoid Arthritis
Affected / at Risk (%)
Total   32/460 (6.96%) 
Blood and lymphatic system disorders   
LEUKOPENIA * 1  1/460 (0.22%) 
THROMBOCYTOPENIA * 1  1/460 (0.22%) 
Cardiac disorders   
CARDIAC FAILURE * 1  1/460 (0.22%) 
MYOCARDIAL INFARCTION * 1  1/460 (0.22%) 
General disorders   
CHEST PAIN * 1  1/460 (0.22%) 
NO THERAPEUTIC RESPONSE * 1  1/460 (0.22%) 
OEDEMA PERIPHERAL * 1  1/460 (0.22%) 
Hepatobiliary disorders   
CHOLECYSTITIS ACUTE * 1  1/460 (0.22%) 
Immune system disorders   
DRUG HYPERSENSITIVITY * 1  1/460 (0.22%) 
HYPERSENSITIVITY * 1  2/460 (0.43%) 
Infections and infestations   
BRONCHITIS * 1  1/460 (0.22%) 
CYTOMEGALOVIRUS HEPATITIS * 1  1/460 (0.22%) 
HERPES OPHTHALMIC * 1  1/460 (0.22%) 
LOCALISED INFECTION * 1  1/460 (0.22%) 
PULMONARY TUBERCULOSIS * 1  1/460 (0.22%) 
TONSILLITIS * 1  1/460 (0.22%) 
VAGINAL INFECTION * 1  1/460 (0.22%) 
Investigations   
ALANINE AMINOTRANSFERASE INCREASED * 1  1/460 (0.22%) 
ASPARTATE AMINOTRANSFERASE INCREASED * 1  1/460 (0.22%) 
Musculoskeletal and connective tissue disorders   
LUPUS-LIKE SYNDROME * 1  1/460 (0.22%) 
OSTEOARTHRITIS * 1  1/460 (0.22%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
LUNG ADENOCARCINOMA * 1  1/460 (0.22%) 
PANCREATIC CARCINOMA * 1  1/460 (0.22%) 
Nervous system disorders   
INTERCOSTAL NEURALGIA * 1  1/460 (0.22%) 
ISCHAEMIC STROKE * 1  1/460 (0.22%) 
LOSS OF CONSCIOUSNESS * 1  1/460 (0.22%) 
Renal and urinary disorders   
RENAL FAILURE * 1  1/460 (0.22%) 
Respiratory, thoracic and mediastinal disorders   
PLEURISY * 1  1/460 (0.22%) 
Skin and subcutaneous tissue disorders   
ECZEMA * 1  1/460 (0.22%) 
ERYTHEMA * 1  2/460 (0.43%) 
PHOTODERMATOSIS * 1  1/460 (0.22%) 
PRURITUS * 1  1/460 (0.22%) 
SKIN DISORDER * 1  1/460 (0.22%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 18.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Rheumatoid Arthritis
Affected / at Risk (%)
Total   0/0 
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.
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.
Results Point of Contact
Name/Title: Global Medical Information
Organization: AbbVie
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01756235     History of Changes
Other Study ID Numbers: P13-683
First Submitted: December 20, 2012
First Posted: December 25, 2012
Results First Submitted: October 26, 2016
Results First Posted: March 6, 2017
Last Update Posted: March 6, 2017