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

• Conditions: moderate to severe active rheumatoid arthritis

• Registration Number: EUCTR2009-011520-53-SK
• Lead Sponsor: Roche Slovensko s.r.o.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-17
• Last Update Posted: 18 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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);Secondary Objective: Safety and tolerability (Serious Adverse Events, Adverse Events leading to premature withdrawal, unexpected tocilizumab related AEs);Primary end point(s): •Percentage of patients fully adherent by the end of the treatment <br>•Number and percentage of patients with all-cause treatment discontinuation<br>•Number and percentage of patients with all-cause premature withdrawal