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SEVRA-TRIAL Safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens in patients with rheumatoid arthritis treated with anti TNF-Š antibodies (adalimumab) and anti B cell therapy (Rituximab).


- candidate number2824
- NTR NumberNTR1088
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-okt-2007
- Secondary IDs06/261 MEC AMC
- Public TitleSEVRA-TRIAL Safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens in patients with rheumatoid arthritis treated with anti TNF-Š antibodies (adalimumab) and anti B cell therapy (Rituximab).
- Scientific TitleSEVRA-TRIAL Safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens in patients with rheumatoid arthritis treated with anti TNF-Š antibodies (adalimumab) and anti B cell therapy (Rituximab).
- ACRONYMSEVRA
- hypothesisTo assess the effect of adalimumab (anti-TNF alpha) and rituximab (anti- B cell) therapy on the safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens.
- Healt Condition(s) or Problem(s) studiedRheumatoid arthritis
- Inclusion criteria1. Able and willing to give written informed consent;
2. A 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. Eligible for anti-TNF Š therapy (according to the Dutch guidelines) or eligible for rituximab therapy;
5. Use of concurrent dmard therapy is allowed, provided the dose and frequency have been stable for at least 28 days. Subjects may be taking nonsteroidal anti-inflammatory drugs, provided the dose and frequency have been stable for at least 28 days. Subjects may be receiving prednisone therapy  10 mg/day provided that the dosage has been stable for at least 2 months prior to entry.
- Exclusion criteria1. A positive PPD skin test (> 4 mm induration);
2. Pregnancy;
3. Breastfeeding;
4. A history of or current acute inflammatory joint disease of different origin e.g. mixed connective tissue disease, seronegative spondylarthropathy, psoriatic arthritis, Reiterís syndrome, systemic lupus erythematosus or any arthritis with onset prior to age 16 years;
5. Acute major trauma;
6. Therapy within the previous 60 days with: any experimental drug,alkylating agents, e.g. cyclophosphamide, chlorambucil, monoclonal antibodies (including infliximab and etanercept), growth factors, or other cytokines;
7. Therapy within the previous 28 days with: parenteral or intra-articular corticoid injections, oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily;
8. HIV infection;
9. History of severe allergic or anaphylactic reactions to vaccines;
10. Vaccination with KLH, Pneumovax, Meningovax, Polio or tetanus toxoid in the past 12 months;
11. Fever (orally measured > 38 įC), chronic infections or infections requiring anti-microbial therapy Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus;
12. Manifest cardiac failure (stage III or IV according to NYHA classification);
13. Progressive fatal disease/terminal illness;
14. Congenital or acquired (known HIV-positive status) immunodeficiency;
15. History of lymphoproliferative disease or treatment with total lymphoid irradiation;
16. White cell count less than 3.5 x 109/l;
17. Platelet count less than 100 x 109/l;
18. Haemoglobin of less than 5.3 mmol/l;
19. Body weight of less than 45 kg;
20. History of drug or alcohol abuse;
21. Any concomitant medical condition which would in the investigatorís opinion compromise the patientís ability to tolerate, absorb, metabolize or excrete the study medication;
22. Inability to give informed consent;
23. Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2007
- planned closingdate1-mei-2010
- Target number of participants40
- InterventionsVaccinatie met KLH, Tetanus vaccine, Hepatitis A vaccine, pneumo 23, Mencevax ACWY en poliomyelitisvaccin.
- Primary outcomePercentage of patients with positive response to vaccination prior and post adalimumab or rituximab therapy, and measured 4 weeks after administration of the vaccins. Response is defined as a 2-fold increase in antibody levels to the administered antigens or as an absolute change in specific antibody of 1 g/mL, or seroconversion in patients with a non-protective baseline level of antibodies (<1/40).
- Secondary outcomeTo analyse the effect of vaccination on RA disease parameters and the influence of adalimumab and rituximab therapy on T and B cell response after vaccination, as well as the relation T-B cell response. This will be done by analyzing T and B cell subsets, T cell cytokine production to specific antibody stimulus measured by elispot and immunoglobuline subtypes.
- TimepointsN/A
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. P.P. Tak
- CONTACT for SCIENTIFIC QUERIESdr P.H. Remans
- Sponsor/Initiator Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
- PublicationsN/A
- Brief summaryEvaluating the effect of anti TNF alpha(adalimumab) therapy and anti B cell therapy (Rituximab) on the safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens in DMARD refractory RA patients.
- Main changes (audit trail)
- RECORD18-okt-2007 - 20-mrt-2008


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