Rheumatoid ArthritisPACENCT01756235
Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice
An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 462 participants
- Where
- No sites listed yet
- Study dates
- Dec 2012to Oct 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)
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.
Read the 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).
- Conditions
- Rheumatoid Arthritis
- Keywords
- Post-marketing observational study (PMOS) Protocol, Rheumatoid Arthritis, Physical Activity, Adalimumab, Humira®
- Medical subject headings
- Arthritis, Rheumatoid, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Rheumatoid Arthritis | Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))
Secondary outcomes (17)
Mean Change From Baseline in Total 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.
Measured: Month 3, Month 6 and Month 9
Mean Change From Baseline in SQUASH-A Scores
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.
Measured: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Mean Change From Baseline in SQUASH-B Scores
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.
Measured: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Mean Change From Baseline in SQUASH-C Scores
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.
Measured: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Mean Change From Baseline in SQUASH-D Scores
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.
Measured: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Mean Change From Baseline in Disease Activity Index - 28 Joints (DAS28) Score
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.
Measured: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Percentage of Participants in Clinical Disease Remission (DAS28<2.6)
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.
Measured: Month 0, Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Percentage of Participants With Low Disease Activity State (LDAS, DAS28<3.2)
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Month 0 and Month 12 LOCF
Correlation Between Physical Activity (Total SQUASH Score and Individual Physical Activity Categories' SQUASH Scores) and HAQ-DI Scores
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Month 0 and Month 12 LOCF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 462 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elena Smirnova, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01756235
- Sponsor's protocol ID
- P13-683
- Acronym
- PACE
- Status last verified
- Jan 2017
- First submitted
- 20 Dec 2012
- Last updated
- 6 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)
- ClinicalTrials.gov ID
- NCT01756235
- Acronym / sponsor ID
- PACE / P13-683
- Conditions
- Rheumatoid Arthritis
- Keywords
- Post-marketing observational study (PMOS) Protocol, Rheumatoid Arthritis, Physical Activity, Adalimumab, Humira®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 462 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 25 Dec 2012 (estimated)
- Results
- Posted 6 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Rheumatoid Arthritis | – | –Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
17 secondary outcomes
Mean Change From Baseline in Total Physical Activity SQUASH Score
Time frame: Month 3, Month 6 and Month 9
Mean Change From Baseline in SQUASH-A Scores
Time frame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Mean Change From Baseline in SQUASH-B Scores
Time frame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Mean Change From Baseline in SQUASH-C Scores
Time frame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
Mean Change From Baseline in SQUASH-D Scores
Time frame: Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Smirnova, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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))). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.