Rheumatoid Arthritis Clinical Trial
Official title:
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.
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.
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Time Perspective: Prospective
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