A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: DMARDs; Tocilizumab
Intervention description: DMARDs may be added to the tocilizumab treatment in any visit, at the discretion of the investigator, according to the local prescription information and participant's tolerance. Study protocol does not specify any particular DMARD.; Tocilizumab will be administered at 8 mg/kg IV dose every 4 weeks for 104 weeks
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This multicenter, open-label, single-arm extension study will evaluate the long-term safety
      of tocilizumab (RoActemra/Actemra) in participants with RA. Participants who have completed
      the MA21488 (NCT00810199) core study and the ML21530 (NCT00754572) study and who could
      benefit from the study drug, according to the opinion of the investigator, will receive 8
      milligrams per kilogram (mg/kg) of intravenous (IV) tocilizumab every 4 weeks. The
      anticipated time on study treatment is 104 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have completed their last visit in the core studies ML21530 and
             MA21488 and that might benefit from treatment using the study drug according to the
             investigator's evaluation

          -  Absence of an AE or current or recent laboratory finding that would prevent the use of
             the 8 mg/kg dose of the tocilizumab

          -  Receiving outpatient treatment

          -  For women who are not postmenopausal and are not surgically sterile: agreement to use
             at least one adequate method of contraception

        Exclusion Criteria:

          -  Participants who have prematurely discontinued the core studies ML21530 and MA21488
             for any reason

          -  MA21488 study participants who remained untreated with tocilizumab after it's
             discontinuation according to the treatment-free remission criteria of MA21488 study

          -  Immunization with a live/attenuated vaccine since the last administration of the study
             drug in the core studies ML21530 and ML21488

          -  Diagnosis after the last visit of the study ML21530 or after the last visit of the
             study MA21488 of a rheumatic autoimmune disease other than RA, including systemic
             erythematous lupus (SEL), mixed connective tissue disease (MCTD), scleroderma and
             polymyositis, or a significant systemic involvement secondary to RA (e.g., vasculitis,
             pulmonary fibrosis or Felty's syndrome). Secondary Sjogren's Syndrome and/or nodulosis
             with RA are allowed

          -  Diagnosis after the last visit of the core study ML21530 or of the study MA21488 of an
             inflammatory joint disease other than RA

          -  Abnormal laboratory parameters at the baseline

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies

          -  Evidences of a concomitant, serious and uncontrolled illness

          -  Known active condition or a history of recurrent infections by bacteria, viruses,
             fungi, mycobacteria or other agents

          -  Evidence of an active malignant disease, malignancies diagnosed in the last 10 years
             or breast cancer diagnosed in the last 20 years

          -  Uncontrolled disease status, such as asthma or inflammatory bowel disease in which
             acute crises are usually treated with oral or parenteral corticosteroids

          -  Current hepatic disease, as determined by the investigator

          -  Active tuberculosis (TB) requiring treatment in the previous three years. Participants
             should be screened for latent TB according to local practice guidelines and should not
             be admitted into the study if latent TB is detected. Participants must not present any
             evidence of active TB infection at the enrollment. Participants treated for
             tuberculosis without recurrence in three years are allowed

          -  History of alcohol, drugs or chemical abuse since the inclusion in the core studies
             ML21530 and MA21488