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: November 6, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Spondylarthropathy
Biological: Prevenar vaccination
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®

Resource links provided by NLM:


Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups. [ Time Frame: 2009 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: August 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Prevenar vaccine Biological: Prevenar vaccination
vaccination with Prevenar vaccine in patients with arthritis

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Region Skane

Additional 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
Study First Received: January 23, 2009
Last Updated: November 6, 2013
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylarthropathies
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014