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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01756235
First received: December 20, 2012
Last updated: January 17, 2017
Last verified: January 2017
  Purpose
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.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Mean Change From Baseline in Total Physical Activity SQUASH Score [ Time Frame: 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 SQUASH-A Scores [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 Scores and Individual Physical Activity Categories' SQUASH Scores in Participants Those Who Did Not Attain Remission or LDAS [ Time Frame: 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 Health Assessment Questionnaire Disability Index (HAQ-DI) Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 462
Study Start Date: December 2012
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Participants with Rheumatoid Arthritis
Participants with rheumatoid arthritis treated with adalimumab in routine 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).
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Study population consisted of participants with rheumatoid arthritis (RA) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756235

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Elena Smirnova, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01756235     History of Changes
Other Study ID Numbers: P13-683
Study First Received: December 20, 2012
Results First Received: October 26, 2016
Last Updated: January 17, 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Post-marketing observational study (PMOS) Protocol
Rheumatoid Arthritis
Physical Activity
Adalimumab
Humira®

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 22, 2017