Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)
Physical activity has positive impacts upon pain, disease activity and functional status in patients with rheumatoid arthritis (RA). Additionally, it may decrease the augmented cardiovascular risk in this patient population. Despite these apparent benefits of physical activity in RA, very little is known about physical activity in patients on biologic therapy. It could be hypothesized that improved control of RA signs and symptoms, better physical function and inhibition of structural damage all make the ground for an increased physical activity in patients treated with biologic agents after inadequate response to conventional Disease Modifying Antirheumatic Drugs (DMARDs).
Adalimumab is the biologic agent which demonstrated unsurpassed efficacy in improving physical function, as well as short- and long-term work productivity outcomes in patients with RA. Therefore, adalimumab is a good candidate biologic agent to evaluate the impact on physical activity in RA.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)|
- Difference in total Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) score [ Time Frame: Day 0 to 12 months ]
- Differences in total physical activity SQUASH score [ Time Frame: Day 0 to 9 months ]
- Differences in *individual physical activity categories' SQUASH scores (*commuting activities, leisure time and sport activities, household activities, activities at work and school) [ Time Frame: Day 0 to 12 months ]
- Difference in DAS28 score [ Time Frame: Day 0 to 12 months ]
- Percentage of patients in clinical disease remission (DAS28<2.6) and low disease activity (LDAS, DAS28<3.2) [ Time Frame: Day 0 to 12 months ]
- Differences in total physical activity SQUASH scores and individual physical activity categories' SQUASH scores between patients in remission or LDAS and those who did not attain remission or LDAS [ Time Frame: Day 0 to 12 months ]
- Difference in HAQ-DI score [ Time Frame: Day 0 to Month 12 ]
- Correlation between physical activity (total SQUASH score and individual physical activity categories' SQUASH scores) and DAS28 scores [ Time Frame: Day 0 to Month 12 ]
- Correlation between physical activity (total SQUASH score and individual physical activity categories' SQUASH scores) and HAQ-DI scores [ Time Frame: Day 0 to Month 12 ]
- Influence of certain sociodemographic factors (age, gender, education and occupation) on physical activity (total SQUASH score and individual physical activity categories' SQUASH scores) [ Time Frame: Day 0 to Month 12 ]
|Study Start Date:||December 2012|
|Study Completion Date:||October 2015|
|Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
This Post-marketing Observational Study (PMOS) will be conducted in a prospective, single-arm, multicenter, multi-country format.
According to the requirements for non-interventional or observational studies, no additional diagnostic or monitoring procedures will be applied to the patients included in the study other than those which would ordinarily be applied in the course of the particular therapeutic strategy. Only data which are part of routine will be collected.
As this is an observational, non-interventional study, patient's treatments are determined solely by the treating physician, which falls within the scope of the physician's/institution's general liability insurance coverage.
As this study is observational in nature, the follow-up visits are not interventional and strictly scheduled, but rather left to the judgment of each investigator. The investigator should record visit data in the Case Report Form (CRF) from no more than five (5) visits, which are closest to the 3- month intervals within the 12-month study period for each patient.
Failure to observe these usual practice intervals of patient visits will not constitute a breach or violation of the protocol.
No more than five (5) patient's visits are indicated for CRF completion within the 12-month observational period:
- Visit 0 (V0): Baseline
- Visit 1 (V1): Follow-up at 3 months
- Visit 2 (V2): Follow-up at 6 months
- Visit 3 (V3): Follow-up at 9 months
- Visit 4 (V4): Follow-up at 12 months (Study End).
A patient may withdraw from this PMOS at any time without prejudice. If the physician, for any reason, decides it is in the best interest of the patient to permanently discontinue adalimumab, treatment should be stopped. The reason for discontinuation should be documented in the CRF.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756235
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|Study Director:||Elena Smirnova, MD||AbbVie|