The objective of this study is to investigate whether there is a change in lipids and bonemarkers and what the frequency of occurence of (riskfactors for) cardiovascular disease, osteoporosis and antibodies during treatment with rituximab.
ID
Source
Brief title
Condition
- Cardiac disorders, signs and symptoms NEC
- Autoimmune disorders
- Joint disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study variables will be a change in lipids (total cholesterol, HDL, LDL
and TG) and lipoproteins (Lp-a, Apo-A1, Apo-B), bonemineral densitiy (DEXA) and
bonemarkers (osteocalcine, OPG, *-CTx and RANKL) and antibodyformation.
Secondary outcome
Secundary study variables will be a change in disease activity (DAS 28),
functional capacity (HAQ-score), radiologic progression (Sharp van der Heyde
score) and B cell count.
Background summary
Since the year 2000 rheumatoid arthritis (RA) can be treated with
immunomodulating drugs (biologicals). One of these agents is rituximab, which
results in B cell depletion by binding selectively on the celmembraneprotein CD
20. Recently it was found that B cells play a major role in the pathogenesis of
rheumatoid arthritis. In rheumatoid arthritis there is a high prevalence and
incidence of comorbidity, i.e. osteoporosis and cardiovascular diseases. It is
unclear what the influence of rituximab is on (these riskfactors for) this
comorbidity in rheumatoid arthritis. Moreover, it's unknown whether antibodies
against rituximab will appear during the treatment with rituximab.
Study objective
The objective of this study is to investigate whether there is a change in
lipids and bonemarkers and what the frequency of occurence of (riskfactors for)
cardiovascular disease, osteoporosis and antibodies during treatment with
rituximab.
Study design
prospective observational multicentre study
Study burden and risks
Patients will be seen eight times for collecting data (including
questionnaires, laboratory and radiologic tests) during the 2 years follow up.
De Boelelaan 1117
1081 HV Amsterdam
Nederland
De Boelelaan 1117
1081 HV Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
According to the thesis of the Dutch association of rheumatology (NVR): treatment with rituximab of rheumatoid arthritis patients:
- rheumatoid arthritis diagnosed according to the ACR criteria 1987
- active rheumatoid arthritis
- previous failure of TNF alpha blocking
Exclusion criteria
- malignity
- active tuberculosis or other active infection
- pregnancy and lactation
- severe heart failure (NYHA IV) or other cardiac disease
- hypersensitivity to one of the active substances of rituximab or murine proteins
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 | NL18857.029.07 |