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A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)

NCT01668966

CompletedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Rheumatoid Arthritis

Interventions: Tocilizumab

Countries: Brazil

This open-label, single arm, multicenter long-term extension study of WA19926 (NCT01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe RA who have completed the 104-week WA19926 (NCT01007435) core study. Eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.

Eligibility overview

Sex: ALL

Age: 18 Months to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participants who completed their last WA19926 (NCT01649804) core study visit (Week 104) and who may benefit from study drug treatment according to the Investigator's assessment
* No current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit
* Women of childbearing potential must agree to use highly reliable contraception during the treatment period

Exclusion Criteria:

* Pregnant or breastfeeding females
* Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason
* Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926 (NCT01649804)
* Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent, or a T-cell costimulation modulator since the last administration of study drug in WA19926 (NCT01649804)
* Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926 (NCT01649804)
* Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of rheumatic autoimmune disease other than RA
* Diagnosis since last WA19926 (NCT01649804) visit (Week 104) of inflammatory joint disease other than RA
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients
* Evidence of severe uncontrolled concomitant disease or disorder
* Known active infections or history of recurrent infections
* Active tuberculosis requiring treatment in the previous 3 years
* History of alcohol, drug or chemical abuse since inclusion in the WA19926 (NCT01649804) study

Locations (6)

Goiânia, Goiás, Brazil
Juiz de Fora, Minas Gerais, Brazil
Curtiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil