To demonstrate non-inferiority of a T2T strategy in which conventional synthetic disease modifying drugs (csDMARDs) refractory RApatients are initially treated with tsDMARD baricitinib versus the comparable T2T strategy in which patients are…
ID
Source
Brief title
Condition
- Autoimmune disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is non-inferiority of tsDAMRD f irst versus TNFi first in
terms of ACR50 response at 12 weeks.
Secondary outcome
* To test for superiority of baricitinib first versus TNFi biological first in
c sDMARDs refractory RA patients in terms of ACR response,
in case of non-inferiority of baricitinib first.
• To evaluate safety of baricitinib versus b iological (TNFi) first in csDMARDs
refractory RA patients.
• To compare time to first remission and time to persistent remission between
treatment arms.
• To compare radiographic outcomes between treatment arms.
• To compare patient reported outcomes between treatment arm s.
• To compare health economical outcomes between treatment arm s.
Background summary
Outcomes of patients with rheumatoid arthritis (RA) have improved markedly over
the last decades, mainly due to the availability of
novel biological therapies and the practice of adjusting treatment to ensure
that predefined disease activity targets are met and
maintained over time, i.e. treat to target (T2T). Despite these developments,
sustained disease control still cannot be achieved in a
substantial sub-population of patients in clinical practice. Recently, a new
class of so called targeted synthetic disease modifying
drugs (tsDAMRD) has become available as a potential additional second line
treatment option for patients with RA. However, not
much is currently known about the real-world benefits these medications provide
when applied within contemporary T2T based
management strategies.
Study objective
To demonstrate non-inferiority of a T2T strategy in which conventional
synthetic disease modifying drugs (csDMARDs) refractory RA
patients are initially treated with tsDMARD baricitinib versus the comparable
T2T strategy in which patients are initially treated with a
biological tumor necrosis factor inhibitor (TNFi) in a pragmatic randomized
trial.
Study design
48-week multi-center, open label, pragmatic, non-inferiority trial.
Intervention
Patients will be randomized ( 1:1) to a treatment strategy starting with
tsDMARD or a treatment strategy starting with TNFi. Patients
will be followed up over the course of 48 weeks with scheduled clinic visits at
0, 12, 24, 36, and 48 weeks, and will also be
encouraged to schedule visits if they experience a disease flare or adverse
events in between scheduled visits. At each visit,
disease activity guided therapeutic adjustments will be made as necessary, with
the aim of achieving clinical remission. In both
groups, therapeutic adjustments include the option to taper or switch
medication, depending on the clinical status of the patient.
Study burden and risks
All medicinal products used in this study have marketing authorization for
patients with rheumatoid arthritis, are recommended in
international guidelines for the target population of this pragmatic trial and
all medicinal products are prescribed at indicated
dosages. Monitoring procedures for this study comply with the CBO guidelines
for rheumatoid arthritis. The study therefore imposes
a similar risk and burden on patients as routine clinical care.
Twekkelerplein 44
Hengelo 7553 LK
NL
Twekkelerplein 44
Hengelo 7553 LK
NL
Listed location countries
Age
Inclusion criteria
Clinical diagnosis of RA
• Active disease defined a s DAS28> 3.2
• Former treatment according to T2T prin ciples, at the discretion of the
attending rheumatologist, i.e. past treatment decisions informed by disease
activity measurements
• Previous use of at least one csDMARD
Exclusion criteria
• Disease duration >5 years
• Previous treatment with any biological DMARD or tsDMARD
• Contraindication for either TNFi or JAK inhibitor
• Latent or active tuberculosis
• Active or recurrent infections
• 3x upper limit of normal ALAT
• GFR < 30 ml/min.
• Failure to provide written informed consent
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2019-000505-72-NL |
| CCMO | NL68883.091.19 |
| Other | NL7547 |