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

NCT ID: NCT01665430

Last Updated: 2018-02-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-02-28

Brief Summary

This multicenter, open-label, single arm long-term extension of study WA19926 will evaluate the safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with early, moderate to severe rheumatoid arthritis who have completed the 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

Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion every 4 weeks up to 104 weeks.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

Tocilizumab will be administered at 8 mg/kg intravenous infusion every 4 weeks, up to 104 weeks.

Interventions

Tocilizumab

Tocilizumab will be administered at 8 mg/kg intravenous infusion every 4 weeks, up to 104 weeks.

Intervention Type: DRUG

Other Intervention Names

RoActemra/Actemra

Eligibility Criteria

Inclusion Criteria

• Participants who complete WA19926 core study (visit at Week 104 and two follow-up telephone visits) 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 tocilizumab 8 mg/kg at baseline visit
• Receiving treatment on an outpatient basis
• Females of child-bearing potential must agree to use at least one adequate method of contraception as defined by protocol during the treatment period

Exclusion Criteria

• Pregnant women
• Participants who have prematurely withdrawn from the WA19926 study for any reason
• Treatment with any investigational agent or cell depleting therapies since last administration of study drug in the WA19926 core study
• Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL)1 agent, or a T-cell co-stimulation modulator since the last administration of the 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 visit at Week 104 of the core WA19926 study of rheumatic autoimmune disease other than rheumatoid arthritis
• Diagnosis since visit at Week 104 of the core WA19926 study of inflammatory joint disease other than rheumatoid arthritis
• Evidence of serious uncontrolled concomitant disease or disorder
• Known active or history of recurrent infection
• Current liver disease as determined by Investigator

• 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

Bytom, , Poland

Elblag, , Poland

Poznan, , Poland

Warsaw, , Poland

Countries

Poland

Other Identifiers

2012-000172-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML28175

Identifier Type: -

Identifier Source: org_study_id