A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis

NCT ID: NCT01655381

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-07-31

Brief Summary

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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab

Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

Tocilizumab 8 mg/kg administered intravenously.

Interventions

Tocilizumab

Tocilizumab 8 mg/kg administered intravenously.

Intervention Type: DRUG

Other Intervention Names

RoActemra®; Actemra®

Eligibility Criteria

Inclusion Criteria

• Adult participants, >/= 18 years of age
• Participants who complete their last WA19926 core study visit (Week 104) and who may benefit from study drug treatment, at baseline or later if they are in remission DAS28 at Week 104 of WA19926, according to the Investigator's assessment
• No current or recent adverse event or laboratory finding preventing the use of the study drug dose of tocilizumab 8 mg/kg at baseline visit
• Women of childbearing potential must agree to use adequate contraception as defined by protocol during and up to 3 months after treatment

Exclusion Criteria

• Pregnant females
• Participants who have withdrawn prematurely from the WA19926 core study for any reason
• Treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in WA19926
• 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
• Immunization with a live/attenuated vaccine since the last administration of study drug in WA19926
• 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
• 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 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 study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Cahors, , France

Montpellier, , France

Mulhouse, , France

Orléans, , France

Paris, , France

Toulouse, , France

Countries

France

Other Identifiers

2011-005516-29

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28174

Identifier Type: -

Identifier Source: org_study_id