E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severe active rheumatoid arthritis |
|
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 |
Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment (adherent patients and all-case discontinuation or premature withdrawal of treatment) |
|
E.2.2 | Secondary objectives of the trial |
Safety and tolerability (Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected tocilizumab related AEs) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients able and willing to sign Inform Consent Form 2.Patients with moderate to severe active rheumatoid arthritis (according to ACR diagnostic criteria) 3.Inadequate response , or intolerance to previous therapy with one or more traditional DMARDs 4.DAS > 3,6 5.Age ≥18 6.Pneumology examination including chest x-ray, Quantiferon test and approval of pneumologist to initiation of biologic treatment 7.Approval of Committee for treatment of resistant form RA in National Institute of Rheumatic Diseases |
|
E.4 | Principal exclusion criteria |
8. Known hypersensitivity to the drug substance or to any of the drug excipients. 9. < 18 years of age 10. Pregnancy or lactation 11. Active infection 12. Active tuberculosis 13. HBsAg, HCV or HIV positivity 14. History of serious allergic or anaphylactic reactions to human or humanized murine monoclonal antibodies 15.History of intestinal ulceration or diverticulitis 16.Active hepatic impairment with ALT or AST > UNL 17.Thrombocytes < 100 000/ mm3, Leucocytes < 3000 mm/3, absolute neutrophil count< 2000 mm/3, 18.Uncontrolled hyperlipoproteinemia 19.Demyelinating disorders 20.Serious cardiovascular disorders 21.Female in fertile age with partners who do not accept usage of contraceptives 22.Concomitant antiTNF drugs |
|
E.5 End points |
E.5.1 | Primary end point(s) |
•Percentage of patients fully adherent by the end of the treatment •Number and percentage of patients with all-cause treatment discontinuation •Number and percentage of patients with all-cause premature withdrawal |
|
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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
|
Last visit of the last subject undergoing the trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |