E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To assess the efficacy of A/H1N1 vaccination in patients treated with rituximab therapy |
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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 |
The aim of this study is to evaluate the effect of rituximab on the efficacy of vaccination with the A/H1N1-vaccine in RA patients
The coprimary immunogenicity end points are the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer (more than 4-fold), and the factor increase in the geometric mean titer (GMT), measured 4 weeks after the last administration of the vaccine. |
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E.2.2 | Secondary objectives of the trial |
The secondary endpoint is to analyse the B-lymphocyte count at the same time point as the determination of the antibody titers.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria for group A - Able and willing to give written informed consent - RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months - Age 18-85 years - Been treated with rituximab and B-cell depleted (<0.1x109/L)
Inclusion criteria for group B - Able and willing to give written informed consent - RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months - Age 18-85 years
Inclusion criteria for healthy volunteers - Able and willing to give written informed consent - Age 18-85 years
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E.4 | Principal exclusion criteria |
Exclusion criteria for group A and B - Therapy within the previous 60 days with: • any experimental drug • monoclonal antibodies ( for group A: other than rituximab) • growth factors • other anti-cytokines - Therapy within the previous 28 days with: • parenteral or intra-articular corticoid injections • oral corticosteroid therapy exceeding a prednisone equivalent of 10 mg daily - Chronic infections or infections requiring anti-microbial therapy. Other active medical conditions such as inflammatory bowel disease, bleeding diathesis, or severe unstable diabetes mellitus - Any concomitant medical condition which would in the investigator’s opinion compromise the patient’s ability to tolerate, absorb, metabolize or excrete the study medication. - Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude.
Exclusion criteria for healthy volunteers - Any clinically significant medical condition
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E.5 End points |
E.5.1 | Primary end point(s) |
The coprimary immunogenicity end points are the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition (HI) assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer (more than 4-fold), and the factor increase in the geometric mean titer (GMT), measured 4 weeks after the last administration of the vaccine. |
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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 | No |
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 | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
other group of RA patients and healthy controls |
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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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end of trial: 4 weeks after the last subject has received the injection |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |