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

Study Overview
=================
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.

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.

Official Title
-----------------
Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®

Conditions
-----------------
Rheumatoid Arthritis, Spondylarthropathy

Intervention / Treatment
-----------------
* Biological: Prevenar vaccination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years Clinical diagnosis of RA or spondylarthropathy Exclusion Criteria: Pregnancy Allergy Has received pneumococcal vaccination within 5 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Prevenar vaccine<br>all participants are immunized with a dose of pneumococcal conjugate vaccine | Biological: Prevenar vaccination<br>* vaccination with Prevenar vaccine in patients with arthritis<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups. |  | 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to analyse if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine. |  | 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rheumatoid arthritis, spondylarthropathy, immunological response following vaccination with Prevenar