Trial record 20 of 51 for:    Open Studies | "Spondylitis, Ankylosing"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01754727
First received: December 19, 2012
Last updated: August 11, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • 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
Study Population

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.

Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754727

Contacts
Contact: Kresimir Furkovic, MD +385 1 2350 531 kresimir.furkovic@abbvie.com
Contact: Jonathan Moller, MD +33 1 4560 1185 jonathan.moller@abbvie.com

  Show 102 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Maja Hojnik 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: August 11, 2014
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, Ankylosing
Spondylitis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 26, 2014