A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

This open-label extension study will evaluate the long-term safety and efficacy of SC TCZ in participants with moderate to severe RA who have completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core studies on SC or intravenous (IV) TCZ. Participants will receive TCZ 162 milligrams (mg) SC every week (QW) or every 2 weeks (Q2W) for up to 96 weeks.

Key facts

Study ID

NCT01662063

Run by

Genentech, Inc.

People needed

218

Starts

2012-08-01

Expected to finish

2014-06-01

Last updated by the study team

2016-10-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed the 97-week WA22762 (NCT01194414) or 96-week NA25220 (NCT01232569) core study on SC or IV TCZ and, based on the Investigator's judgment, may continue to benefit from TCZ 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

You may not qualify if…

• Premature withdrawal from WA22762 (NCT01194414) or NA25220 (NCT01232569) 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 at greater than (>) 10 mg per day prednisone or equivalent, or non-steroidal anti-inflammatory drugs (NSAIDs) above the maximum recommended dose
• Intra-articular or parenteral corticosteroids within 4 weeks prior to Baseline
• Treatment with any investigational or commercially available biologic disease-modifying anti-rheumatic drug (DMARD) other than TCZ at any time between completion of the core study WA22762 (NCT01194414) or NA25220 (NCT01232569) and enrollment in the long-term extension study
• Pregnant or breastfeeding women
• History of alcohol, drug, or chemical abuse within 1 year prior to Screening

Where it is running

• Study site — Peoria, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Fullerton, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — San Diego, California, United States
• Study site — San Leandro, California, United States
• Study site — Upland, California, United States
• Study site — Van Nuys, California, United States
• Study site — West Hills, California, United States
• Study site — Whittier, California, United States
• Study site — Denver, Colorado, United States
• Study site — Bridgeport, Connecticut, United States
• Study site — Trumbull, Connecticut, United States
• Study site — Jupiter, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — South Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Venice, Florida, United States
• Study site — Tuscaloosa, Alabama, United States

Full record on ClinicalTrials.gov

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