Completed

A Multi-Center, Non-Interventional Study to Evaluate Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACROSS)

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

Arthritis+6

+ Autoimmune Diseases

+ Connective Tissue Diseases

Over 18 Years

+7 Eligibility Criteria

See all 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: July 2012

See protocol details

Summary

Principal SponsorHoffmann-La Roche

Last updated: February 23, 2017

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 non-interventional study evaluated the use and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment according to the approved label were followed for 6 months.

NCT01671059

Principal SponsorHoffmann-La Roche

Last updated: February 23, 2017

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

80 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 participants, >= 18 years of age

Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria

Participants in whom the treating physician made the decision to commence tocilizumab treatment (in accordance with the local label); this could include participants who had received tocilizumab treatment within 8 weeks prior to the enrollment visit

4 exclusion criteria prevent from participating

History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Participants who had previously received tocilizumab in a clinical trial or for compassionate use

Participants who had received tocilizumab more than 8 weeks prior to the enrollment visit

Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever was longer) before starting treatment with tocilizumab

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 8 locations

Institut Za Reumatologiju; Reumatologiju

Belgrade, SerbiaOpen Institut Za Reumatologiju; Reumatologiju in Google Maps

Military Medical Academy; Clinic of Rheumatology

Belgrade, Serbia

Institute of Rheumatology and Cardiovascular Diseases; Rheumatology

Niška Banja, Serbia

Completed8 Study Centers