A Long-Term Extension Study of WA22762 and NA25220 of RoActemra/Actemra (Tocilizumab) Administered Subcutaneously in Patients With Moderate to Severe Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:August 2012
End Date:June 2014

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A Multicenter, Open Label Long Term Extension Study of WA22762 and NA25220 to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

This open-label extension study will evaluate the long-term safety and efficacy of
subcutaneous (SC) RoActemra/Actemra in patients with moderate to severe rheumatoid arthritis
who have completed the 97-week WA22762 or 96-week NA25220 core studies on subcutaneous or
intravenous (IV) RoActemra/Actemra. Patients will receive RoActemra/Actemra 162 mg
subcutaneously every week or every 2 weeks (qw or q2w). Anticipated time on study treatment
is 96 weeks.


Inclusion Criteria:

- Completed the 97-week WA22762 or 96-week NA25220 core study on SC or IV
RoActemra/Actemra and, based on the investigator's judgment, may continue to benefit
from RoActemra/Actemra treatment in this study investigating the SC formulation

- Receiving treatment on an outpatient basis

- Females of childbearing potential and males with female partners of childbearing
potential must agree to use reliable means of contraception as defined by protocol

Exclusion Criteria:

- Patients who have prematurely withdrawn form WA22762 or NA25220 core studies for any
reason

- History of severe allergic or anaphylactic reactions to human, humanized, or murine
monoclonal antibodies

- Evidence of serious uncontrolled concomitant disease or disorder

- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial
or other infections

- Any major episode of infection requiring hospitalization or treatment with iv
antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of
screening

- History of or currently active primary or secondary immunodeficiency

- Oral corticosteroids > 10 mg/day prednisolone or equivalent or NSAIDs > maximum
recommended dose

- Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline

- Treatment with any investigational or commercially available biologic DMARD other
than RoActemra/Actemra at any time between completion of the core study (WA22762 or
NA25220) and enrollment in the LTE study

- Pregnant or breastfeeding women

- History of alcohol, drug or chemical abuse within 1 year prior to screening
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