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

Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01756235

Acronym

PACE

Enrollment

462

Registered

2012-12-25

Start date

2012-12-31

Completion date

2015-10-31

Last updated

2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Post-marketing observational study (PMOS) Protocol, Rheumatoid Arthritis, Physical Activity, Adalimumab, Humira®

Brief summary

The purpose of this study was to evaluate physical activity and its changes in participants with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.

Detailed description

This post-marketing observational study was conducted in a multi-country, multi-center and single-arm format. Data were collected prospectively. Adult participants with diagnosis of RA who were assigned for treatment with adalimumab (Humira®) were eligible for participation. During this period four follow-up visits were planned for observation of the participant and documentation of data. Ideally, these visits should have been performed approximately 3 (V1), 6 (V2), 9 (V3) and 12 (V4) months after the baseline visit (V0).

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Had rheumatoid arthritis (RA) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines * Had been started on adalimumab therapy no more than one (1) month prior to the study enrolment * Had negative result of tuberculosis (TB) screening test or was receiving TB prophylaxis as per local guidelines * Had provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion criteria

* Was unable to walk either due to RA or a comorbid condition * Was unable to perform basic self-care activities * Had contraindications for treatment with adalimumab

Design outcomes

Primary

Measure	Time frame	Description
Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score	Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))	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.

Secondary

Measure	Time frame	Description
Mean Change From Baseline in SQUASH-A Scores	Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Mean Change From Baseline in SQUASH-B Scores	Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Mean Change From Baseline in SQUASH-C Scores	Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Mean Change From Baseline in SQUASH-D Scores	Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score	Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Percentage of Participants in Clinical Disease Remission (DAS28<2.6)	Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)	Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Mean Change From Baseline in Total Physical Activity SQUASH Scores and Individual Physical Activity Categories' SQUASH Scores in Participants in Remission or LDAS	Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Mean Change From Baseline in Total Physical Activity SQUASH Score	Month 3, Month 6 and Month 9	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.
Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score	Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores	Month 0 and Month 12 LOCF	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.
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores	Month 0 and Month 12 LOCF	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.
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Age Categories	Month 0 and Month 12 LOCF	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.
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Gender	Month 0 and Month 12 LOCF	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.
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Education	Month 0 and Month 12 LOCF	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.
Mean Change From Baseline in Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) Influenced by Occupation	Month 0 and Month 12 LOCF	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.
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	Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF	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.

Participant flow

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.

Participants by arm

Arm	Count
Participants With Rheumatoid Arthritis Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.	460
Total	460

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adalimumab Treatment was not Documented	2

Baseline characteristics

Characteristic	Participants With Rheumatoid Arthritis
Age, Continuous	53.9 years STANDARD_DEVIATION 12.1
Gender Female	378 Participants
Gender Male	82 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 0
serious Total, serious adverse events	32 / 460

Outcome results

Primary

Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score

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))