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Effects of Different Antirheumatic Treatments of Arthritis on Antibody Response Following Vaccination Using Prevenar® (PVA)

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ClinicalTrials.gov Identifier: NCT00828997
Recruitment Status : Completed
First Posted : January 26, 2009
Last Update Posted : December 12, 2018
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane

Brief Summary:

Previous studies have analyzed serological responses following pneumococcal vaccination using 23-valent vaccination (Pneumovax) in Rheumatoid Arthritis (RA) patients that were on different therapeutic modalities including TNF-blockers and methotrexate. The results have shown that serological response was significantly reduced in RA patients receiving methotrexate compared to those receiving TNF-blockers.

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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Spondylarthropathy Biological: Prevenar vaccination Phase 4

Detailed Description:

Background: Previous studies have analyzed serological responses following pneumococcal vaccination using 23-valent vaccination (Pneumovax) in Rheumatoid Arthritis (RA) patients that were on different therapeutic modalities including TNF-blockers and methotrexate. The results have shown that serological response was significantly reduced in RA patients receiving methotrexate compared to those receiving TNF-blockers (Rheumatology (Oxford) 2006 Jan; 45(1):106-11).

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 505 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®
Study Start Date : August 2008
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018


Arm Intervention/treatment
Prevenar vaccine
all participants are immunized with a dose of pneumococcal conjugate vaccine
Biological: Prevenar vaccination
vaccination with Prevenar vaccine in patients with arthritis




Primary Outcome Measures :
  1. Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups. [ Time Frame: 2009 ]

Secondary Outcome Measures :
  1. to analyse if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine. [ Time Frame: 2009 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Clinical diagnosis of RA or spondylarthropathy

Exclusion Criteria:

  • Pregnancy
  • Allergy
  • Has received pneumococcal vaccination within 5 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00828997


Locations
Sweden
Lund, Sweden
Sponsors and Collaborators
Region Skane
Lund University
Investigators
Principal Investigator: Meliha C Kapetanovic, MD,PhD Dept of Rheumatology, Lund University Hospital, Lund, Sweden

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT00828997     History of Changes
Other Study ID Numbers: EU-nr 2007-006539-29
First Posted: January 26, 2009    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: December 2018

Keywords provided by Region Skane:
rheumatoid arthritis
spondylarthropathy
immunological response following vaccination with Prevenar

Additional relevant MeSH terms:
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Arthritis
Arthritis, Rheumatoid
Spondylarthropathies
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs