Effects of Different Antirheumatic Treatments of Arthritis on Antibody Response Following Vaccination Using Prevenar®
NCT ID: NCT00828997
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
505 participants
INTERVENTIONAL
2008-08-31
2018-01-31
Brief Summary
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In contrast when using polypeptide immunisation (influenza vaccine) we found that anti-TNF significantly impaired the serological response compared to the methotrexate treated RA patients. The aim of this study is to analyze serological responses after Prevenar vaccination in patients with chronic arthritis and to study the impact of different treatment modalities on serological responses.
It will be of interest to see if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.
Detailed Description
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In contrast when using polypeptide immunisation (influenza vaccine) we found that anti-TNF significantly impaired the serological response compared to the methotrexate treated RA patients.
The aim of this study is to analyze serological responses after PREVENAR vaccination in patients with RA or spondylarthropathy and to study the impact of different treatment modalities on serological responses.
It will be of interest to see if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.
Study design:
Unblinded study in RA patients and patients with spondylarthropathies. All subjects will be vaccinated once with Prevenar and the serological response will be followed by blood draws.
Patient Population to be Included:
RA patients on methotrexate and/or other DMARDS RA patients on anti-TNF drugs as monotherapy RA patients on anti-TNF +MTX and/or other DMARDSs Spondylarthropathy patients on anti-TNF drugs as monotherapy Spondylarthropathy patients on anti-TNF drugs +MTX Spondylarthropathy patients on NSAIDs (There is a possibility to stratify for steroid use).
Primary and Secondary Efficacy Endpoints:
Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups.
An ethical approval from the Ethical Review Board at Lund University is mandatory for this study as well as an approval from the Swedish MPA.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Prevenar vaccine
all participants are immunized with a dose of pneumococcal conjugate vaccine
Prevenar vaccination
vaccination with Prevenar vaccine in patients with arthritis
Interventions
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Prevenar vaccination
vaccination with Prevenar vaccine in patients with arthritis
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of RA or spondylarthropathy
Exclusion Criteria
* Allergy
* Has received pneumococcal vaccination within 5 years
18 Years
ALL
No
Sponsors
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Lund University
OTHER
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Meliha C Kapetanovic, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Dept of Rheumatology, Lund University Hospital, Lund, Sweden
Locations
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Lund, , Sweden
Countries
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References
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Nagel J, Geborek P, Saxne T, Jonsson G, Englund M, Petersson IF, Nilsson JA, Truedsson L, Kapetanovic MC. The association between antibody levels before and after 7-valent pneumococcal conjugate vaccine immunization and subsequent pneumococcal infection in chronic arthritis patients. Arthritis Res Ther. 2015 May 19;17(1):124. doi: 10.1186/s13075-015-0636-z.
Nagel J, Geborek P, Saxne T, Jonsson G, Englund M, Petersson IF, Nilsson JA, Kapetanovic MC. The risk of pneumococcal infections after immunization with pneumococcal conjugate vaccine compared to non-vaccinated inflammatory arthritis patients. Scand J Rheumatol. 2015;44(4):271-9. doi: 10.3109/03009742.2014.984754. Epub 2015 Feb 6.
Crnkic Kapetanovic M, Saxne T, Jonsson G, Truedsson L, Geborek P. Rituximab and abatacept but not tocilizumab impair antibody response to pneumococcal conjugate vaccine in patients with rheumatoid arthritis. Arthritis Res Ther. 2013 Oct 30;15(5):R171. doi: 10.1186/ar4358.
Crnkic Kapetanovic M, Saxne T, Truedsson L, Geborek P. Persistence of antibody response 1.5 years after vaccination using 7-valent pneumococcal conjugate vaccine in patients with arthritis treated with different antirheumatic drugs. Arthritis Res Ther. 2013 Jan 4;15(1):R1. doi: 10.1186/ar4127.
Roseman C, Truedsson L, Kapetanovic MC. The effect of smoking and alcohol consumption on markers of systemic inflammation, immunoglobulin levels and immune response following pneumococcal vaccination in patients with arthritis. Arthritis Res Ther. 2012 Jul 23;14(4):R170. doi: 10.1186/ar3923.
Kapetanovic MC, Roseman C, Jonsson G, Truedsson L, Saxne T, Geborek P. Antibody response is reduced following vaccination with 7-valent conjugate pneumococcal vaccine in adult methotrexate-treated patients with established arthritis, but not those treated with tumor necrosis factor inhibitors. Arthritis Rheum. 2011 Dec;63(12):3723-32. doi: 10.1002/art.30580.
Other Identifiers
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EU-nr 2007-006539-29
Identifier Type: -
Identifier Source: org_study_id