The follow-up study has two main research questions:o Is the treatment of early RA according to the COBRA-light schedule as effective (based on DAS44 score, ACR/EULAR remission criteria, HAQ score and the Sharp/van der Heijde score) as standard…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The most important parameters of the follow-up study are the status of disease
activity (DAS44 score), functional capacity (HAQ score) and radiological
progression (Sharp/van der Heijde score) per treatment group after 48 months.
The results of both treatment groups will be compared with each other. In
addition, the average disease activity, functional capacity and radiological
progression of the past 48 months will be calculated and compared between
treatment both groups.
Secondary outcome
Secondary study parameters of the study are the level of improvement of the
patients (ACR response score), RA medication use, adverse events and potential
additional medication use and the Charlson Comorbidity Index (CCI).
Background summary
Recent research showed that COBRA-light therapy is clinically non-inferior to
standard COBRA therapy: both strategies effectively lower disease activity
after six months treatment in early, active RA patients. As it is of major
importance to investigate the long term effects of the new treatment, we would
like to initiate a new study to investigate the effects of the COBRA-light
treatment after four years follow-up.
Study objective
The follow-up study has two main research questions:
o Is the treatment of early RA according to the COBRA-light schedule as
effective (based on DAS44 score, ACR/EULAR remission criteria, HAQ score and
the Sharp/van der Heijde score) as standard COBRA therapy after four years?
o What is the course of the disease in this group of early RA patients, who
were intensively treated according to modern combination therapies during the
past four years?
Study design
The follow-up study is an observational study, consisting of one visit per
patient. The measurements will, on average, be performed four years after
inclusion.
Study burden and risks
The follow-up study consists of one visit per patient, which will take about
two to three hours per patient. The next measurements will be performed during
this measure moment: a short interview, a physical examination (among others:
height and weight, waist-hip-circumference, examination of the joints,
bioelectrical impedance analysis and an ultrasound examination of the carotid
arteries) and the patient will be asked to fill out eight questionnaires. In
addition, blood will be collected at the laboratory, an electrocardiogram will
be made, and X-ray photo*s and DXA-scans will be made at the Radiology
department.
The risks of the follow-up study consist of the (usual) risk at blood
collection and an additional radiation burden, as patients participating in
this study are exposed to additional X-rays, compared to regular health care,
when the whole-body DXA-scan is performed. The amount of extra radiation to
which the patient is exposed during this measurement is 0.01 mSv, which is
lower than the amount of additional radiation that is allowed in our country.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
All patients who participated in the COBRA-light-study (and who started with the therapy).
Exclusion criteria
Patients who did not start with the COBRA therapy
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 | NL42005.029.12 |