Completed
A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
What is being collected
Drug Data
Collected from today forward - ProspectiveDrug
Who is being recruted
Arthritis+6
+ Autoimmune Diseases
+ Connective Tissue Diseases
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Observational
Study Start: March 2012
Summary
Principal SponsorHoffmann-La Roche
Last updated: October 24, 2016
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2012
Actual date on which the first participant was enrolled.This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.
Principal SponsorHoffmann-La Roche
Last updated: October 24, 2016
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
43 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.
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
3 inclusion criteria required to participate
Adult patients, >= 18 years of age
Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or need of RoActemra/Actemra monotherapy); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
4 exclusion criteria prevent from participating
Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
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
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 9 locations
Balikpapan, IndonesiaOpen in Google Maps
Bandung, Indonesia
Central Jakarta, Indonesia
Central Java, Indonesia
Completed9 Study Centers