NCT01715831 - A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488 | Crick

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events (NSAEs)

An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. SAE was an AE resulting in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; significant medical event, according to the investigator discretion (e.g., may represent a risk to the participant or may require medical/surgical intervention to prevent one of the outcomes mentioned above).

Time frame: From Baseline up to approximately 2 years

Number of Participants With AEs Leading to Dose Modification or Study Discontinuation

Time frame: From Baseline up to approximately 2 years

Number of Participants With AEs of Special Interest

Adverse events of special interest included following events: Infections (including opportunistic infections); myocardial infarction / acute coronary syndrome; gastrointestinal (GI) perforations and related events; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; hemorrhagic events; and hepatic events. Overall number of participants who experienced any of these AEs of special interest was reported.

Time frame: From Baseline up to approximately 2 years

Secondary Outcomes

Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)

DAS28 score is a measure of participant's disease activity calculated using tender joint count in 28 joints (TJC28), swollen joint count in 28 joints (SJC28), participant's global assessment of disease activity (general health \[GH\]) using visual analog scale (VAS), 0 millimeter (mm)=no disease activity to 100 mm=maximum disease activity, displayed on the 100 mm horizontal VAS, and acute phase response (erythrocyte sedimentation rate \[ESR\] in millimeters per hour \[mm/hr\]) for a total possible score of 0 to 10. The score is calculated using the following formula: DAS28 = \[0.56 multiplied by (\*) square root (√) of TJC28\] plus (+) \[0.28\*√SJC28\]+\[0.70\*the natural logarithm (ln) ESR\]+\[0.014\*GH\]. DAS28-ESR score varies from 0 to 10, where higher scores represent greater disease activity.

Time frame: Baseline, Weeks 12, 24, 36, 48, 56, 68, 80, 92, 104, and follow-up (FU) Visit 1 (Week 108), FU Visit 2 (Week 116)

Tender Joint Count (TJC)

An assessment of 28 joints was conducted for tenderness. Joints were assessed and classified as tender/not tender by pressure and joint manipulation after a physical examination. Artificial joints, arthrodesis or fused joints were not taken into consideration for tenderness.