Suspended
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
What is being tested
Tocilizumab
Drug
Who is being recruted
Arthritis+6
+ Autoimmune Diseases
+ Connective Tissue Diseases
Over 18 Years
+14 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 3
Interventional
Study Start: July 2012
Summary
Principal SponsorHoffmann-La Roche
Last updated: February 8, 2018
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorHoffmann-La Roche
Last updated: February 8, 2018
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
38 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 Years
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
4 inclusion criteria required to participate
Females of child-bearing potential must agree to use at least one adequate method of contraception as defined by protocol during the treatment period
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
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
Receiving treatment on an outpatient basis
10 exclusion criteria prevent from participating
Current liver disease as determined by Investigator
Diagnosis since visit at Week 104 of the core WA19926 study of inflammatory joint disease other than rheumatoid arthritis
Diagnosis since visit at Week 104 of the core WA19926 study of rheumatic autoimmune disease other than rheumatoid arthritis
Evidence of serious uncontrolled concomitant disease or disorder
Show More Criteria
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
ExperimentalParticipants will receive tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion every 4 weeks 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 4 locations
Suspended4 Study Centers