E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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E.2.2 | Secondary objectives of the trial |
-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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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).
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |