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 |
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.
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- Patients who have prematurely withdrawn form WA22762 or NA25220 core studies for any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
We found this trial at
75
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials