Completed

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

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What is being tested

Tocilizumab

Drug
Who is being recruted

Arthritis+6

+ Autoimmune Diseases

+ Connective Tissue Diseases

Over 18 Months
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 2013
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: May 13, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: December 9, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorHoffmann-La Roche
Last updated: May 13, 2019
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

23 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Months

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue DiseasesArthritis, Rheumatoid

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) every 4 weeks for up to 104 weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

CIP - Centro Internacional de Pesquisa

Goiânia, BrazilOpen CIP - Centro Internacional de Pesquisa in Google Maps

Centro Mineiro de Pesquisa - CMIP

Juiz de Fora, Brazil

Centro de Estudos em Terapias Inovadoras - CETI

Curtiba, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Brazil
Completed6 Study Centers