Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rheumatoid Arthritis
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 462
- Primary Endpoint
- Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score
Time Frame: 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 Outcomes
- Mean Change From Baseline in SQUASH-B Scores(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in SQUASH-D Scores(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- Mean Change From Baseline in SQUASH-C Scores(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- 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)
- 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)
- Mean Change From Baseline in Total Physical Activity SQUASH Score(Month 3, Month 6 and Month 9)
- Mean Change From Baseline in SQUASH-A Scores(Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- 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)
- Percentage of Participants in Clinical Disease Remission (DAS28<2.6)(Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF)
- 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)
- Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and DAS28 Scores(Month 0 and Month 12 LOCF)
- Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores(Month 0 and Month 12 LOCF)
- 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)
- 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)
- 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)
- 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)