Impact of Adalimumab (Humira) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice (IDEA)
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Purpose
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.
| Condition |
|---|
|
Ankylosing Spondylitis |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Impact of Adalimumab (Humira) Therapy on Selected Health Care Resource Utilization and Sick Leave in Patients With Ankylosing Spondylitis in Clinical Practice |
- Change in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) [ Time Frame: From Day 0 to Month 12 ] [ Designated as safety issue: No ]Percentage of patients who exhibit treatment response at the end of the observational period of 12 months as compared with baseline. Response is defined at least 50% from baseline (BASDAI 50)
- Change in BASDAI 50 (Bath Ankylosing Spondylitis Daily Activity Index) [ Time Frame: From Day 0 to Month 9 ] [ Designated as safety issue: No ]Percentage of patients who exhibit treatment response defined as BASDAI 50 from baseline to month 3, 6 and 9
- Change in Ankylosing Spondylitis Disease activity (ASDAS) score [ Time Frame: From Day 0 to Month 12 ] [ Designated as safety issue: No ]Percentage of patients who exhibit treatment response defined as ASDAS≥2.0 from baseline to month 3, 6, 9 and 12
- Change in the Number of hospital inpatient days [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy
- Change in the Number of hospitalizations [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy
- Change in the Number of sick leave days [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)
- Change in the Number of sick leaves [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)
- Change in the Number of outpatient visits to each kind of health care provider: general practitioner, rheumatologist, other specialists, physiotherapist, rheumatology nurse [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]Difference in the number of outpatient visits to each kind of health care provider: general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist, rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy
- Change in BASDAI 50 (Bath Ankylosing Spondylitis Daily Activity Index) [ Time Frame: From Day 0 to Month 12 ] [ Designated as safety issue: No ]Change in BASDAI score between baseline and month 3, 6, 9 and 12
- Change in Ankylosing Spondylitis Disease activity (ASDAS) score [ Time Frame: From Day 0 to Month 12 ] [ Designated as safety issue: No ]Change in ASDAS score between baseline and month 3, 6, 9 and 12
- Change in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI) [ Time Frame: From Day 0 to Month 12 ] [ Designated as safety issue: No ]Change in BASFI score between baseline and month 3, 6, 9 and 12
| Estimated Enrollment: | 460 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Ankylosing Spondylitis |
Detailed 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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
This study is a post-marketing observational study (PMOS) in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
Study population will consist of adult (aged ≥18 years) patients with ankylosing spondylitis (AS) that can be treated with adalimumab as per locally approved label and prescription guidelines.
Inclusion Criteria:
- Has ankylosing spondylitis (AS) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines,
- Is adult (aged ≥ 18 years)
- Has been started on adalimumab therapy no more than one (1) month prior to the study enrollment
- Has negative result of tuberculosis screening test or is receiving tuberculosis prophylaxis as per local guidelines
- 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
Exclusion Criteria:
• Has contraindications for the treatment with adalimumab (please see the latest version of the locally approved label)
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01754727
Show 74 Study Locations
| Study Director: | Liliana Iosub | AbbVie |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01754727 History of Changes |
| Other Study ID Numbers: | P13-682 |
| Study First Received: | December 19, 2012 |
| Last Updated: | February 16, 2015 |
| Health Authority: | Romania: Ethics Committee Croatia: Ethics Committee Russia: Ethics Committee Hungary: Institutional Ethics Committee Czech Republic: Ethics Committee |
Keywords provided by AbbVie:
|
Post-marketing observational study (PMOS) Protocol Ankylosing Spondylitis Effectiveness of adalimumab (Humira) |
Additional relevant MeSH terms:
|
Spondylitis Spondylitis, Ankylosing Ankylosis Arthritis Bone Diseases Bone Diseases, Infectious Infection Joint Diseases Musculoskeletal Diseases |
Spinal Diseases Spondylarthritis Spondylarthropathies Adalimumab Anti-Inflammatory Agents Antirheumatic Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 27, 2015