Clareo Health | A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Negative pregnancy test at screening and baseline
Participants who have completed the 97-week WA22762 LTE study on SC or intravenous (IV) TCZ and who experienced, at any time during WA22762, clinically significant improvement in DAS28 (\>1.2 points), and based on the investigator's judgment may continue to benefit from TCZ treatment in this study investigating the SC formulation
No current or recent adverse events or laboratory findings preventing the use of the study drug dose of TCZ 162 mg SC at baseline visit
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 during the study and for at least 3 months following the last dose of study drug
Oral corticosteroids and non-steroidal anti-inflammatory drugs (NSAIDS) up to the recommended dose are permitted if on stable dose regimen for greater than and equal to (\>/=) 4 weeks prior to baseline
Permitted non-biological disease-modifying anti-rheumatic drugs (DMARDs) are allowed
You may not be if
Participants who have prematurely withdrawn from the WA22762 LTE study for any reason
Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies
Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell co stimulation modulator since the last administration of study drug in the WA22762 LTE study
Immunization with a live/attenuated vaccine since the last administration of study drug in the WA22762 LTE study
Diagnosis, since last WA22762 visit (Week 97), of rheumatic autoimmune disease other than rheumatoid arthritis; secondary Sjörgen's syndrome with RA is permitted
Diagnosis, since last WA22762 visit (Week 97), of inflammatory joint disease other than RA
Uncontrolled disease states, such as asthma or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
Evidence of serious uncontrolled concomitant disease
Known active current or history of recurrent infection
Primary or secondary immunodeficiency (history of or currently active)
Body weight \>150 kilograms (kg)
Pregnant or lactating women
Inadequate hematologic, renal or liver function
History of alcohol, drug or chemical abuse within 1 year prior to screening
