Ankylosing Spondylitis Clinical Trial
Official title:
Impact of Adalimumab (Humira) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice
Ankylosing Spondylitis (AS) is a disease that represents a considerable economic burden to
the health care system as well as the whole society. The introduction of biologic therapy,
though allowing for superior clinical and work productivity outcomes, has significantly
increased direct medical costs of AS. Therefore it is important to weight the benefits
against the costs to gain a basis for decisions on health care resource allocation.
Due to differences in the health care systems, health insurance and general country
settings, health economic data cannot be generalized across countries. Such data is
generally lacking in Central and Eastern European countries, especially in the field of
rheumatology. This study will evaluate selected health care resource utilization and
productivity losses in patients with AS during and before the treatment with adalimumab in
clinical practice. The impact of adalimumab therapy on the extent of outpatient attendance,
hospitalizations and sick leave, which could be influenced by relatively short-term
adalimumab therapy, will be taken into account, and in relation to treatment response. There
is no published data on the impact of adalimumab therapy on hospitalizations and outpatient
attendance in patients with AS. Further, data on health care resource utilization and sick
leave before and during adalimumab therapy could be translated into financial cost estimates
(potential cost savings) by each participating country, based on their own country specific
cost per resource.
This Post-marketing Observational Study (PMOS) will be conducted in a prospective,
single-arm, multicenter, multi-country format.
Retrospective data will be obtained by medical chart or electronic record review.
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
;
Time Perspective: Prospective
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