A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS

Hoffmann-La Roche0 sites13 target enrollmentOctober 2012

ConditionsRheumatoid Arthritis

Interventionstocilizumab [RoActemra/Actemra]

Drugstocilizumab [RoActemra/Actemra]

Overview

Phase: Phase 3
Intervention: tocilizumab [RoActemra/Actemra]
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 13
Primary Endpoint: Long-term safety: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This multicenter, open-label, single arm, long-term extension study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe rheumatoid arthritis who completed the WA19926 core study. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

May 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Patients who complete their last WA19926 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 the study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit
•Receiving treatment on an outpatient basis
•Females of childbearing potential must agree to use at least one adequate method of contraception, including a method with a failure rate of \<1% per year, during the treatment period

Exclusion Criteria

•Pregnant or lactating women
•Patients who have prematurely withdrawn from the WA19926 core study for any reason
•Treatment with an investigational agent or cell-depleting therapies since the last administration of study drug in the WA19926 core study
•Immunization with a live/attenuated vaccine since the last administration of study drug in the WA19926 core study
•Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other than rheumatoid arthritis
•Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than rheumatoid arthritis
•Inadequate liver, hematologic or renal function
•History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
•Known active or history of recurrent infections
•Evidence of active malignant disease, malignancies within the previous 10 years (except for basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years

Arms & Interventions

RoActemra/Actemra

Intervention: tocilizumab [RoActemra/Actemra]

Outcomes

Primary Outcomes

Long-term safety: Incidence of adverse events

Time Frame: approximately 3 years

Secondary Outcomes

Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)(from baseline to Week 104)
Change in total tender joint count (TJC) / swollen joint count (SJC)(from baseline to Week 104)
Proportion of patients achieving sustained drug-free remission, defined as clinical remission based on DAS28-ESR <2.6 and/or SDAI </=3 for two consecutive visits (every 12 weeks) followed by RoActemra/Actemra discontinuation after the 2nd visit(approximately 3 years)
Time to rheumatoid arthritis flare in patients who have entered drug-free remission(approximately 3 years)