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.
Conditions
Interventions
Trade Name: Prevenar vaccine
Product Name: Prevenar vaccine
Pharmaceutical Form: Injection*
INN or Proposed INN: 7-valent Pneumococcal Conjugate vaccine
Sponsors
Dept of Rheumatology, Lund University Hospital, Lund, Sweden
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the study using PREVENAR vaccine -to study the impact of different treatments on serological response after vaccination with 7-valent pneumococcal vaccine (PREVENAR) in patients with established arthritis ;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 - to study if Prevenar vaccination is well tolerated in patients with arthritis ;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. | — |
Countries
Sweden
Outcome results
None listed