An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NCT00106574 \[Roche protocol WA18063\], and NCT00109408 \[Roche protocol WA17824\]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

Key facts

Study ID

NCT00720798

Run by

Hoffmann-La Roche

People needed

2067

Starts

2005-09-01

Expected to finish

2013-04-01

Last updated by the study team

2014-09-30

Who can join

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

You may qualify if…

• Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.

You may not qualify if…

• Treatment with any investigational agent since the last administration of study drug in the core studies.
• Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
• Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
• Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
• Previous treatment with any cell-depleting therapies, including investigational agents.
• Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.

Where it is running

• Study site — Huntsville, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Paradise Valley, Arizona, United States
• Study site — Peoria, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Long Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Los Angeles, California, United States
• Study site — Palm Desert, California, United States
• Study site — Palm Springs, California, United States
• Study site — Palo Alto, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Jose, California, United States
• Study site — San Leandro, California, United States
• Study site — Santa Maria, California, United States
• Study site — Torrance, California, United States
• Study site — Upland, California, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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