Effects of different anti-rheumatic treatments of arthritis on antibody response following pneumococcal vaccination using Prevenar

• Conditions: Patients with rheumatic diseases (rheumatoid arthritis and spondyloarthripaties) who are going to be vaccinated with Prevenar vaccine in order to study the serological responses to two pneumococcal serotypes and to study the impact of different treatment modalities on serological responses.

• Registration Number: EUCTR2007-006539-29-SE
• Lead Sponsor: Dept of Rheumatology, Lund University Hospital, Lund, Sweden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-20
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

All patients with chronic arthritis treated with biologic agents ( such as TNF-blockers, IL-1 blocker or those receiving anti-CD20 treatment) at Dept of Rheumatology in Lund and followed up with structured clinical protocol are eligible for this study. Thus the following groups of patients are planned to be studied:
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 DMARDs
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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

age<18 years, pregnancy, allergi against the active substance in the vaccine, treatment with bilogical agens for conditions other than rheumatoid arthritis (RA) or spondylarthrophaties, ongoing infection

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Aim of the study using PREVENAR vaccine<br><br>-to study the impact of different treatments on serological response after vaccination with 7-valent pneumococcal vaccine (PREVENAR) in patients with established arthritis<br>;Secondary Objective: -to examine if result of the study using 23-valent nonconjugated pneumococcal vaccine could be confirmed when conjugate vaccine consisting of 7 polysaccharide antigen (14, 6B, 19F, 4, 9V, 18C and 23F) is used<br>- to study if Prevenar vaccination is well tolerated in patients with arthritis <br>;Primary end point(s): Serological responses to two pneumococcal serotypes included in Prevenar vaccine between different treatment groups. At least a twofold increase in levels of IgG will be regarded adequate response and sufficient for protection to pneumococcal infection.