Pnemococcal vaccination of rheumatoid arthritis patients in biological treatment
Phase 1
- Conditions
- Immunoresponse on pneumococcal vaccination of rheumatoid arthritis patients in immunomodulatory therapyMedDRA version: 18.0Level: LLTClassification code 10069594Term: Pneumococcal immunizationSystem Organ Class: 100000004865Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-001299-79-DK
- Lead Sponsor
- Department of Infectious Diseases, Odense University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosed with rheumatoid arthritis
- Over 18 years old
- Not pregnant
- Receiving immunomodulatory therapy for rheumatoid arthritis (for randomized group)
- Patient at theumatology outpatient clinic at Odense University Hospital or King Christian X's Hospital for Rheumatic Diseases
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 2
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 98
Exclusion Criteria
- Hypersensitivity to diphtheria toxoid, active substance or excipients in the vaccines.
- Pneumovax vaccination within the last 12 months
- Refuses to be vaccinated
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: A direct head-to-head comparison of the specific pneumococcal antibody level pre and post vaccination in the different study groups, for Prevenar and Pneumovax, independently of treatment for rheumatoid arthritis.;Secondary Objective: A comparison of the specific pneumococcal antibody level pre and postvaccination (for Prevenar and Pneumovax) in the different treatment groups dependent on the treatment for rheumatoid arthritis.;Primary end point(s): The primary endpoint is a head-to-head comparison of the specifik pneumococcal antibody titer pre and post vaccination in the different study groups, independent of the treatment for rheumatoid arthritis.;Timepoint(s) of evaluation of this end point: Medio 2016
- Secondary Outcome Measures
Name Time Method Secondary end point(s): A comparison of the specific pneumococcal antibody titer pre and post vaccination in the different study groups, dependent on the treatment for rheumatoid arthritis.;Timepoint(s) of evaluation of this end point: Medio 2016