E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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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 primary objective of this study is to evaluate the long-term safety and tolerability of fostamatinib in patients with active rheumatoid arthritis (RA) by assessment of adverse event (AE) reports, laboratory safety data, vital signs, electrocardiograms (ECGs) and physical examination. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are:
•To assess the long-term efficacy of fostamatinib as measured by:
-Signs and symptoms of RA, as measured by components of American
College of Rheumatology (ACR) response criteria and Disease Activity
Score based on a 28 joint count (DAS28) score.
-Structural joint damage, as measured by radiographic modified total
Sharp score (mTSS) and components of mTSS.
•To assess physical function status of patients after administration of
fostamatinib using the Health Assessment Questionnaire - Disability
Index (HAQ-DI).
•To investigate the effects of fostamatinib on patient reported health
outcomes as measured by the 36-item Short Form Health Survey (SF-
36). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For inclusion in the study patients must fulfil the following criteria.
1.Provision of informed consent, prior to any study-specific procedures.
2.Patients who have successfully completed a qualifying study (ie, Studies D4300C00001, D4300C00002, D4300C00003 or D4300C00004) with fostamatinib.
Or
Patients who have participated in a qualifying study and who have been classified as non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001, D4300C00002, D4300C00003).
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E.4 | Principal exclusion criteria |
Patients must not enter the study if any of the following exclusion criteria are fulfilled:
1.Premature discontinuation of investigational product or withdrawal from the qualifying study.
2.Development of any of the withdrawal criteria from the qualifying study
3.Females who are pregnant or lactating.
4.Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.
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E.5 End points |
E.5.1 | Primary end point(s) |
As this is an extension study, no endpoints have been defined. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
As this is an extension study, no endpoints have been defined. |
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E.5.2 | Secondary end point(s) |
As this is an extension study, no endpoints have been defined. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
As this is an extension study, no endpoints have been defined. |
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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 | Yes |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Study will become open label once the qualifying studies are completed |
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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 |
No placebo as the primary objective of the study is to collect long-term safety data |
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E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 101 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Belgium |
Brazil |
Bulgaria |
Canada |
Chile |
Czech Republic |
Estonia |
France |
Germany |
Hungary |
India |
Israel |
Italy |
Latvia |
Lithuania |
Mexico |
Netherlands |
Peru |
Poland |
Portugal |
Romania |
Russian Federation |
Serbia |
Slovakia |
South Africa |
Spain |
Ukraine |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | Yes |
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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This extension study (also known as OSKIRA-X) is planned to complete by the end of 2014 (ie, duration of 4 years). |
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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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |