To compare the cost-effectiveness from a societal perspective of three treatment options, abatacept, rituximab or a anti-TNF alpha agent, for patients with rheumatoid arthritis who failed at least one anti-TNF alpha agent. Simultaneously, this study…
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes are the DAS28 at 12 months, quality adjusted life years and
societal costs over 12 months.
Secondary outcome
Secondary outcomes are the health assessment questionnaire, the short-form 36,
time to failure and the percentage of patients crossing over to another
treatment.
Background summary
A direct comparison of the efficacy and medication costs as measured in
controlled clinical trials (as often provided by the pharmaceutical companies)
might be an invalid representation of the effectiveness and costs in daily
clinical practice. To have the best balance between internal and external
validity, we propose a pragmatic randomized trial. The results of such study
could give valuable evidence for a common practice driven policy decision about
the prescription of abatacept, rituximab or another TNF alpha blocking
treatment for RA patients.
Study objective
To compare the cost-effectiveness from a societal perspective of three
treatment options, abatacept, rituximab or a anti-TNF alpha agent, for patients
with rheumatoid arthritis who failed at least one anti-TNF alpha agent.
Simultaneously, this study will provide data on the use of these medications in
detail with regard to doses, frequencies and patient population in daily
clinical practice.
Study design
We propose, following upcoming guidelines about expensive inpatient
pharmaceuticals, a pragmatic randomized trial. To prevent confounding by
indication, all patients are being randomized to start treatment either with
abatacept, rituximab or an anti TNF alpha agent. Thereafter, the treatment
strategy will be at the discretion of the attending rheumatologist meaning that
the rheumatologist is free to change treatment.
Intervention
a treatment with abatacept, rituximab or an anti-TNF alpha agent
Study burden and risks
because of the pragmatic design, patients are treated at the discretion of
their own rheumatologist. According to the Dutch guidelines, a patients on a
treatment with one of the biological agents should be monitored every three
months on his/ her disease activity. Follow-up visits for this study will be
planned on the same day as the visit at the out-patient clinic. For this study,
additional questionaires have to be administered to measure functional ability
(HAQ), quality of life (EQ-5d and SF-36) and the medical consumption.
postbus 9101
6500 HB Nijmegen
NL
postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
1) RA diagnosis according to ACR criteria
2) been treated adequately with one of the anti-TNF alpha agents with insufficient effects;
3) a moderate to high disease activity (DAS28 > 3.2)
Exclusion criteria
1) former treatment with abatacept or rituximab.
2) patient's or physician's preference for one of the agents
3) contraindications
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24611.091.08 |