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

NCT ID: NCT01668966

Last Updated: 2019-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-09
• Study Completion Date: 2016-05-11

Brief Summary

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.

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) intravenously (IV) every 4 weeks for up to 104 weeks.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.

Interventions

Tocilizumab

Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.

Intervention Type: DRUG

Other Intervention Names

RoActemra, Actemra

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• Participants who have withdrawn prematurely from the WA19926 (NCT01649804) core study for any reason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

• Minimum Eligible Age: 18 Months
• 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

CIP - Centro Internacional de Pesquisa

Goiânia, Goiás, Brazil

Centro Mineiro de Pesquisa - CMIP

Juiz de Fora, Minas Gerais, Brazil

Centro de Estudos em Terapias Inovadoras - CETI

Curtiba, Paraná, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Universidade Federal de Sao Paulo - UNIFESP; Reumatologia

São Paulo, São Paulo, Brazil

Centro Paulista de Investigacao Clinica - CEPIC

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ML28080

Identifier Type: -

Identifier Source: org_study_id