To determine the efficacy and safety of abatacept SC in rheumatoid arthritis patients in daily clinical practice over 24 months. In addition, the retention rate of abatacept SC will be assessed during this study.
ID
Source
Brief title
Condition
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Efficacy will be determined in comparison to baseline by measuring disease
activity, radiological progression and
functional capacity during follow-up. Safety will be determined by the
occurrence of side effects.
Secondary outcome
nvt
Background summary
1) Abatacept, a co-stimulation blocker via CD 86 competition, has recently been
approved as subcutaneous (SC) injections in the Netherlands for the treatment
of moderate to severe rheumatoid arthritis. As efficacy in daily clinical
practice can differ from the clinical (registration) trials, e.g due to
different patient groups, it is important to monitor the daily clinical
practice.
2) Recent evidence suggests that Abatacept SC has a low immunogenicity and
favorable safety and clinical efficacy in patients with RA when administered in
the presence or absence of background MTX and in the absence of an initial
intraveneous (IV) loading, this should be further investigated in daily
clinical practice
Study objective
To determine the efficacy and safety of abatacept SC in rheumatoid arthritis
patients in daily clinical practice over 24 months. In addition, the retention
rate of abatacept SC will be assessed during this study.
Study design
Prospective observational cohort study of patients diagnosed with moderate to
severe active RA and initiated and treated with abatacept SC. Efficacy and
safety data will be collected throughout the study.
Study burden and risks
Consists of an extra blood sample taken concurrently with regular/routine
laboratory testing.Optionally genetic factors directly influencing the
inflammatory process will be determined. Reference samples might be used for
example for determination of glucose metabolism, lipd profile and inflammatory
markers.
dr Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
dr Jan van Breemenstraat 2
Amsterdam 1056 AB
NL
Listed location countries
Age
Inclusion criteria
Patients * 18 years old at treatment initiation
Patients informed and accepting to participate (Written informed consent)
Patients diagnosed with established moderate to severe active RA as per the 1987 ACR criteria/2010 ACR/EULAR Rheumatoid Arthritis Classification Criteria
Patients who at their physician*s discretion are initiated with abatacept SC.
Exclusion criteria
Patients currently participating in any interventional clinical trial in RA
Contraindications against abatacept SC treatment.
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 | NL45634.048.13 |