Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis (RA)

An observational study of Rheumatoid Arthritis, run by Abbott at 10 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluation of Health Related Quality of Life (HRQL) is of a paramount importance in assessing the impact of rheumatoid arthritis on patients' health status, however when costs associated with rheumatoid arthritis are also taken into account, the information provided may lead to a more balanced view in analyzing the… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
How many people: 124 participants
Where: 10 sitesGreece
Study dates: Nov 2007to Jun 2010
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients with rheumatoid arthritis, from hospital centres and private physicians, who were prescribed adalimimab according to the approved SmPC in the European Union, prior to the study enrollment

Who may be able to join

Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving adalimumab under normal clinical practice for at least one month and according to the approved Summary of Product Characteristics (SmPC) in the European Union.
Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Who cannot join

Contraindications according to the SmPC
Patients should not participate in other observational Abbott study

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

Greece10 sites

Site Reference ID/Investigator# 32052
Athens, 115 21
Site Reference ID/Investigator# 32068
Athens, 115 27
Site Reference ID/Investigator# 32069
Athens, 11527
Site Reference ID/Investigator# 32071
Crete, 71500
Site Reference ID/Investigator# 32072
Ioannina, 45500
Site Reference ID/Investigator# 32073
Larissa, 41221
Site Reference ID/Investigator# 32064
Thessaloniki, 54636
Site Reference ID/Investigator# 32065
Thessaloniki, 54642
Site Reference ID/Investigator# 32066
Thessaloniki, 564 29
Site Reference ID/Investigator# 32067
Thessaloniki, 570 10

Other trials in Greece

About this study

Official title: Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis

In accordance with the above, the main objective this study was to evaluate the impact of adalimumab treatment not only on patients' Health Related Quality of Life but also on the cost of the disease management. In order to accomplish this the study has been focused on:

Estimating the direct and indirect cost incurred by adalimumab treatment.
Measuring the Health Related Quality of Life of rheumatoid arthritis patients under adalimumab treatment.
Exploring the cost-utility relationship of rheumatoid arthritis patients treated with adalimumab by combining the Health Related Quality of Life of rheumatoid arthritis patients and direct as well as indirect costs due to RA.

More specifically, data related to patients' Health Related Quality of Life and cost associated with rheumatoid arthritis will be recorded for one-year period, and collected at four subsequent visits: baseline, month 3, 6 and 12. The visit before starting treatment with adalimumab will be considered as baseline. This information was used to compare Health Related Quality of Life and cost data before and after adalimumab initiation and therefore identify the effect of adalimumab treatment in patients with rheumatoid arthritis.

Read the detailed description

Data concerning patients' Health Related Quality of Life as well as the cost of the disease treatment were collected at four subsequent periods and specifically at baseline (Visit 1), and at months 3, 6 and 12.

Moreover, at baseline patients' socioeconomic, and history of illness data as well as the use of other prescribed medication and costs due to rheumatoid arthritis have been recorded, in order to identify patients' health state before adalimumab treatment initiation.

Patients discontinuing therapy (drop-outs) either due to adverse events or on their own initiative were categorized and analyzed separately, while reasons leading to discontinuation were recorded. Adverse events were not collected in this study with the exception of adverse events leading to withdrawal.

In order to evaluate the cost-utility of adalimumab both the cost of the disease treatment and the Health Related Quality of Life of rheumatoid arthritis patients have been taken into account. The process is described below:

Face-to-face interviews were conducted by the physicians/investigators in charge in all four subsequent periods as well as before adalimumab treatment initiation. A questionnaire, divided into the following sections, was administered: 1. Patients' Sociodemographic Characteristics 2. Measurement of Health Related Quality of Life in Rheumatoid Arthritis patients 3. Cost Assessment

Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Adalimumab treatment, Evaluation of the patients' Health Related Quality of Life, Cost of the disease management
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01078116
Study group	Role	What they receive
Patients with Rheumatoid Arthritis		Eligible rheumatoid arthritis patients treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union

What is being measured

The primary outcome is the main question the study is designed to answer.

Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability.
Measured: Enrollment visit (Baseline), month 3, month 6, month 12
Health Related Quality of Life (European Quality of Life 5 Dimensions)
European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health.
Measured: Enrollment visit (Baseline), month 3, month 6, month 12
Health Related Quality of Life (Health Assessment Questionnaire)
Health Assessment Questionnaire (HAQ) is designed to assess patients' abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes.
Measured: Enrollment visit (Baseline), month 3, month 6, month 12
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best).
Measured: Enrollment visit (Baseline), month 3, month 6, month 12
Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)
The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years [QALYs]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2007Jun 2010

First posted2 Mar 2010 (estimated)
Study startNov 2007
Primary completionJun 2010
Study completionJun 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 124 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01078116
Sponsor's protocol ID: P10-159
Acronym: HEOR
Status last verified: Aug 2011
First submitted: 26 Feb 2010
Last updated: 11 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cost Utility Analyses of Adalimumab Treatment in Patients With Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01078116
Acronym / sponsor ID: HEOR / P10-159
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis, Adalimumab treatment, Evaluation of the patients' Health Related Quality of Life, Cost of the disease management
Study type: Observational
Recruitment status: Completed
Enrolment: 124 participants (actual)
Lead sponsor: AbbottIndustry (pharma, biotech, devices)
Collaborators: Institute of Political Economical & Social Researches, Greece
Study start: Nov 2007
Primary completion: Jun 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 2 Mar 2010 (estimated)
Results: Posted 25 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Estimating the direct and indirect cost incurred by adalimumab treatment.
Measuring the Health Related Quality of Life of rheumatoid arthritis patients under adalimumab treatment.
Exploring the cost-utility relationship of rheumatoid arthritis patients treated with adalimumab by combining the Health Related Quality of Life of rheumatoid arthritis patients and direct as well as indirect costs due to RA.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with Rheumatoid Arthritis	–	–Eligible rheumatoid arthritis patients treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients with rheumatoid arthritis, from hospital centres and private physicians, who were prescribed adalimimab according to the approved SmPC in the European Union, prior to the study enrollment

Key inclusion criteria (2 listed)

Patients with moderate or severe active rheumatoid arthritis, who have been prescribed and are receiving adalimumab under normal clinical practice for at least one month and according to the approved Summary of Product Characteristics (SmPC) in the European Union.
Patients must be willing to consent to data being collected and provided to Abbott Laboratories.

Key exclusion criteria (2 listed)

Contraindications according to the SmPC
Patients should not participate in other observational Abbott study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment
Time frame: Enrollment visit (Baseline), month 3, month 6, month 12
Direct and indirect per-participant costs were estimated at Baseline (enrollment visit) for the 3-month period prior to initiation of adalimumab treatment, and at 3, 6 and 12 months following initiation of treatment. Direct costs included pharmaceutical costs, diagnostic and monitoring test costs, hospitalization costs, rheumatologist's costs, social insurance rheumatologist's costs, other specialists costs, physiotherapy costs, rehabilitation cost, home care cost, equipment cost and transportation cost. Indirect costs refer to loss of income due to rheumatoid arthritis disability.
Health Related Quality of Life (European Quality of Life 5 Dimensions)
Time frame: Enrollment visit (Baseline), month 3, month 6, month 12
European Quality of Life 5 Dimensions (EQ-5D) is a generic health related quality of life instrument which assesses 5 health dimensions on a scale of 1 (no problems) to 5 (worst health). An overall score is derived ranging from -.59 to +1; a higher score indicates better health.
Health Related Quality of Life (Health Assessment Questionnaire)
Time frame: Enrollment visit (Baseline), month 3, month 6, month 12
Health Assessment Questionnaire (HAQ) is designed to assess patients' abilities to perform activities of daily living. Scores range between 0 and 3, where higher values represent worse outcomes.
Health Related Quality of Life (Medical Outcome Study Short Form 36)
Time frame: Enrollment visit (Baseline), month 3, month 6, month 12
Medical Outcome Study Short Form 36 (MOS SF-36) is a generic health related quality of life assessment that consists of 36 questions within 8 domains. Results from each domain are summarized and transformed into a scale ranging from 0 (worst) to 100 (best).
Cost-Utility Relationship of Rheumatoid Arthritis Patients Treated With Adalimumab Using Incremental Cost-Effectiveness Approach (ICER)
Time frame: 12 months
The ICER calculation is based on comparison of differences in costs and utilities (based on Quality of Life Adjusted years [QALYs]) between Baseline and the 12 month visit. The ICER represents the extra costs that have to be incurred for one extra unit of perfect health to be produced. A treatment is determined to be cost-effective if the ICER is below a certain threshold (National Health Systems of European Union have suggested a threshold of 50,000 euros).

Results and safety

Results posted to the registry on 25 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Adalimumab Treatment	124	76

Primary outcome: Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment

Time frame: Enrollment visit (Baseline), month 3, month 6, month 12. Mean (Standard Deviation). Unit: Euros

Measure	Adalimumab Treatment n = 121
Direct Costs at Baseline (n=121)	272.99 (383.48)
Indirect Costs at Baseline (n=13)	1162.62 (1146.60)
Direct Costs at 3 months (n=104)	2662.73 (446.86)
Indirect Costs at 3 months (n=8)	659.13 (648.82)
Direct Costs at 6 months (n=91)	2692.28 (243.82)
Indirect Costs at 6 months (n=4)	500.00 (336.65)
Direct Costs at 12 months (n=76)	2649.42 (533.47)
Indirect Costs at 12 months (n=1)	580.00 (0)

Population analysed: Analysis is based on the number of participants completing the assessments at each visit.

Primary outcome: Health Related Quality of Life (European Quality of Life 5 Dimensions)

Time frame: Enrollment visit (Baseline), month 3, month 6, month 12. Mean (Standard Deviation). Unit: Units on a scale

Measure	Adalimumab Treatment n = 121
EQ-5D Score at Baseline	0.43 (0.16)
EQ-5D Score at 3 months	0.53 (0.23)
EQ-5D Score at 6 months	0.56 (0.23)
ED-5D Score at 12 months	0.62 (0.25)

Population analysed: Analysis is based on the number of participants completing the assessments at each visit.

Primary outcome: Health Related Quality of Life (Health Assessment Questionnaire)

Time frame: Enrollment visit (Baseline), month 3, month 6, month 12. Mean (Standard Deviation). Unit: units on a scale

Measure	Adalimumab Treatment n = 121
HAQ Score at Baseline	1.33 (0.70)
HAQ Score at 3 months	0.95 (0.80)
HAQ Score at 6 months	0.83 (0.64)
HAQ Score at 12 months	0.62 (0.64)

Population analysed: Analysis is based on the number of participants completing the assessment at each time point.

Primary outcome: Health Related Quality of Life (Medical Outcome Study Short Form 36)

Time frame: Enrollment visit (Baseline), month 3, month 6, month 12. Mean (Standard Deviation). Unit: Units on a scale

Measure	Adalimumab Treatment n = 121
Physical Functioning Score at Baseline	33.5 (26.0)
Physical Functioning Score at 3 months	50.0 (29.4)
Physical Functioning Score at 6 months	56.4 (27.8)
Physical Functioning Score at 12 months	60.0 (28.9)
Role Physical Score at Baseline	18.7 (34.0)
Role Physical Score at 3 months	36.8 (43.3)
Role Physical Score at 6 months	41.0 (43.7)
Role Physical Score at 12 months	51.0 (45.0)

Population analysed: Analysis is based on the number of participants completing the assessment at each time point.

Adverse events

Time frame: Adverse event data were not collected in this study with the exception of adverse events leading to withdrawal. Adverse events are collected in the main study NCT 01086033 (GREC-2004-06) and will be reported upon completion of that study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adalimumab Treatment	3 of 124 (2.4%)	2 of 124 (1.6%)	Not reported

Limitations and caveats (from the sponsor): Study NCT 01078116 (P10-159) is a substudy of NCT 01086033(GREC-2004-06). Adverse events were not recorded in this study but will be reported in the main study upon completion. Only adverse events leading to withdrawal are reported in this substudy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thanasis Floros, MD study chair

Abbott Laboratories Hellas S.A.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Abbott at 10 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimation of the Direct and Indirect Cost Incurred by Adalimumab Treatment (time frame: Enrollment visit (Baseline), month 3, month 6, month 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01078116.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2011.