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Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar® (PVA)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Lund University
Information provided by (Responsible Party):
Region Skane
ClinicalTrials.gov Identifier:
NCT00828997
First received: January 23, 2009
Last updated: September 5, 2011
Last verified: September 2011
History of Changes

January 23, 2009
September 5, 2011
August 2008
December 2011   (final data collection date for primary outcome measure)
Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups. [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00828997 on ClinicalTrials.gov Archive Site
to analyse if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine. [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®
Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®

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.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Rheumatoid Arthritis
  • Spondylarthropathy
Biological: Prevenar vaccination
vaccination with Prevenar vaccine in patients with arthritis
Not Provided
Kapetanovic MC, Roseman C, Jönsson 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
500
December 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy
  • Allergy
  • Has received pneumococcal vaccination within 5 years
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT00828997
EU-nr 2007-006539-29
Yes
Region Skane
Region Skane
Lund University
Principal Investigator: Meliha C Kapetanovic, MD,PhD Dept of Rheumatology, Lund University Hospital, Lund, Sweden
Region Skane
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP