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

Ankylosing Spondylitis Clinical Trial

— IDEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754727
• Other study ID #: P13-682
• Status: Completed
• Phase: N/A
• First received: December 19, 2012
• Last updated: November 19, 2015
• Start date: December 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ethics CommitteeHungary: Institutional Ethics CommitteeRomania: Ethics CommitteeCzech Republic: Ethics CommitteeRussia: Ethics Committee
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 421
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Croatia	Site Reference ID/Investigator# 95219	Opatija
Croatia	Site Reference ID/Investigator# 95218	Split
Croatia	Site Reference ID/Investigator# 95214	Zagreb
Croatia	Site Reference ID/Investigator# 95215	Zagreb
Croatia	Site Reference ID/Investigator# 95216	Zagreb
Croatia	Site Reference ID/Investigator# 95217	Zagreb
Czech Republic	Site Reference ID/Investigator# 100987	Brno
Czech Republic	Site Reference ID/Investigator# 100983	Chomutov 1
Czech Republic	Site Reference ID/Investigator# 121469	Jihlava
Czech Republic	Site Reference ID/Investigator# 121470	Kromeriz
Czech Republic	Site Reference ID/Investigator# 100980	Moravska Ostrava a Privoz
Czech Republic	Site Reference ID/Investigator# 100977	Prague 2
Czech Republic	Site Reference ID/Investigator# 100978	Prague 2
Czech Republic	Site Reference ID/Investigator# 121463	Prague 2
Czech Republic	Site Reference ID/Investigator# 100982	Prague 5
Czech Republic	Site Reference ID/Investigator# 100986	Uherske Hradiste
Hungary	Site Reference ID/Investigator# 99935	Budapest
Hungary	Site Reference ID/Investigator# 99937	Budapest
Hungary	Site Reference ID/Investigator# 129327	Debrecen
Hungary	Site Reference ID/Investigator# 99938	Debrecen
Hungary	Site Reference ID/Investigator# 99939	Eger
Hungary	Site Reference ID/Investigator# 101655	Esztergom
Hungary	Site Reference ID/Investigator# 119497	Gyor
Hungary	Site Reference ID/Investigator# 99942	Gyula
Hungary	Site Reference ID/Investigator# 99949	Heviz
Hungary	Site Reference ID/Investigator# 99950	Kecskemet
Hungary	Site Reference ID/Investigator# 99951	Kistarcsa
Hungary	Site Reference ID/Investigator# 99952	Miskolc
Hungary	Site Reference ID/Investigator# 99953	Nyiregyhaza
Hungary	Site Reference ID/Investigator# 99940	Szeged
Hungary	Site Reference ID/Investigator# 99954	Szekesfehervar
Hungary	Site Reference ID/Investigator# 99955	Szombathely
Hungary	Site Reference ID/Investigator# 99941	Veszprem
Romania	Site Reference ID/Investigator# 96509	Barlad
Romania	Site Reference ID/Investigator# 96508	Brasov
Romania	Site Reference ID/Investigator# 100195	Bucharest
Romania	Site Reference ID/Investigator# 100197	Bucharest
Romania	Site Reference ID/Investigator# 106315	Bucharest
Romania	Site Reference ID/Investigator# 93739	Bucharest
Romania	Site Reference ID/Investigator# 93740	Bucharest
Romania	Site Reference ID/Investigator# 93741	Bucharest
Romania	Site Reference ID/Investigator# 96507	Bucharest
Romania	Site Reference ID/Investigator# 100198	Cluj-Napoca
Romania	Site Reference ID/Investigator# 95325	Constanta
Romania	Site Reference ID/Investigator# 95324	Craiova
Romania	Site Reference ID/Investigator# 95326	Craiova
Romania	Site Reference ID/Investigator# 96517	Deva
Romania	Site Reference ID/Investigator# 104035	Iasi
Romania	Site Reference ID/Investigator# 107855	Iasi
Romania	Site Reference ID/Investigator# 107856	Iasi
Romania	Site Reference ID/Investigator# 95330	Iasi
Romania	Site Reference ID/Investigator# 95331	Iasi
Romania	Site Reference ID/Investigator# 96519	Iasi
Romania	Site Reference ID/Investigator# 104616	Ploiesti
Romania	Site Reference ID/Investigator# 96520	Ploiesti
Romania	Site Reference ID/Investigator# 95328	Targu-Mures
Russian Federation	Site Reference ID/Investigator# 94625	Kazan
Russian Federation	Site Reference ID/Investigator# 94621	Khabarovsk
Russian Federation	Site Reference ID/Investigator# 94623	Khanty-Mansiysk
Russian Federation	Site Reference ID/Investigator# 105440	Moscow
Russian Federation	Site Reference ID/Investigator# 105442	Moscow
Russian Federation	Site Reference ID/Investigator# 105443	Moscow
Russian Federation	Site Reference ID/Investigator# 105445	Moscow
Russian Federation	Site Reference ID/Investigator# 105457	Moscow
Russian Federation	Site Reference ID/Investigator# 94618	Moscow
Russian Federation	Site Reference ID/Investigator# 94619	Moscow
Russian Federation	Site Reference ID/Investigator# 94627	Moscow
Russian Federation	Site Reference ID/Investigator# 94615	St-Petersburg
Russian Federation	Site Reference ID/Investigator# 94616	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 105459	Surgut
Russian Federation	Site Reference ID/Investigator# 94629	Tula
Russian Federation	Site Reference ID/Investigator# 94620	Voronezh

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Croatia,  Czech Republic,  Hungary,  Romania,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI)	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)	From Day 0 to Month 12	No
Secondary	Change in BASDAI 50 (Bath Ankylosing Spondylitis Daily Activity Index)	Percentage of patients who exhibit treatment response defined as BASDAI 50 from baseline to month 3, 6 and 9	From Day 0 to Month 9	No
Secondary	Change in Ankylosing Spondylitis Disease activity (ASDAS) score	Percentage of patients who exhibit treatment response defined as ASDAS=2.0 from baseline to month 3, 6, 9 and 12	From Day 0 to Month 12	No
Secondary	Change in the Number of hospital inpatient days	Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy	From "Day 0 - 12 months" to "Day 0 + 12 months"	No
Secondary	Change in the Number of hospitalizations	Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy	From "Day 0 - 12 months" to "Day 0 + 12 months"	No
Secondary	Change in the Number of sick leave days	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)	From "Day 0 - 12 months" to "Day 0 + 12 months"	No
Secondary	Change in the Number of sick leaves	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)	From "Day 0 - 12 months" to "Day 0 + 12 months"	No
Secondary	Change in the Number of outpatient visits to each kind of health care provider: general practitioner, rheumatologist, other specialists, physiotherapist, rheumatology nurse	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	From "Day 0 - 12 months" to "Day 0 + 12 months"	No
Secondary	Change in BASDAI 50 (Bath Ankylosing Spondylitis Daily Activity Index)	Change in BASDAI score between baseline and month 3, 6, 9 and 12	From Day 0 to Month 12	No
Secondary	Change in Ankylosing Spondylitis Disease activity (ASDAS) score	Change in ASDAS score between baseline and month 3, 6, 9 and 12	From Day 0 to Month 12	No
Secondary	Change in Bath Ankylosing Spondylitis Daily Activity Index (BASDAI)	Change in BASFI score between baseline and month 3, 6, 9 and 12	From Day 0 to Month 12	No

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