Impact of Adalimumab (Humira) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice — IDEA  

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

• NCT number: NCT01754727
• Study type: Observational
• Source: AbbVie
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Completion date: October 2015