No registrations found.
ID
Source
Brief title
Health condition
RA, reumatoide artritis, Rheumatoid Arthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The coprimary immunogenicity end points are the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer (more than 4-fold), and the factor increase in the geometric mean titer (GMT).
Secondary outcome
N/A
Background summary
N/A
Study objective
Since previous studies suggest that an influenza vaccination is probably less or even not effective in rituximab treated RA patients, we want to investigate if this also holds true for this new vaccine against the H1N1 virus.
Study design
Prior to vaccine administration and 4 weeks after second vaccination.
Intervention
All patients and volunteers will receive an A/H1N1 vaccine according to the National Guidelines. The administration of the vaccine will be coordinated by the Dutch government. Before the first vaccination and 4 weeks after the second vaccination serum samples will be collected and B-lymphocyte counts will be assessed. Functional tests on the isolated B- and T lymphocytes will be performed.
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
P.O. Box 22660
P.P. Tak
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
p.p.tak@amc.nl
Inclusion criteria
Inclusion criteria for group A:
1. Able and willing to give written informed consent;
2. RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months;
3. Age 18-85 years;
4. Been treated with rituximab and B-cell depleted (<0.1x109/L).
Inclusion criteria for group B:
1. Able and willing to give written informed consent;
2. RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months;
3. Treatment with methotrexate;
4. Age 18-85 years.
Inclusion criteria for healthy volunteers:
1. Able and willing to give written informed consent;
2. Age 18-85 years.
Exclusion criteria
Exclusion criteria for groups A and B:
1. Therapy within the previous 60 days with:
A. Any experimental drug;
B. Monoclonal antibodies (for group A: other than rituximab);
C. Growth factors;
D. Other anti-cytokines.
2. Therapy within the previous 28 days with:
A. Parenteral or intra-articular corticoid injections;
B. Oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily.
3. Chronic infections or infections requiring anti-microbial therapy. Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus;
4. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
Exclusion criteria for healthy volunteers:
1. Any clinically significant medical condition.
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 |
|---|---|
| NTR-new | NL2338 |
| NTR-old | NTR2445 |
| Other | MEC AMC / EUdraCT : 09/312 / 2009-016789-10 ; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |