NCT02721004

Brief Summary

This is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
592

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 28, 2016

Completed
Last Updated

July 4, 2016

Status Verified

July 1, 2016

Enrollment Period

5.8 years

First QC Date

March 2, 2016

Last Update Submit

July 1, 2016

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisRoActemraTocilizumab

Outcome Measures

Primary Outcomes (6)

  • Disease Activity Score Based on 28-joints Count (DAS28)

    Month 12

  • Simplified Disease Activity Index (SDAI) Score

    Month 12

  • Clinical Disease Activity Index (CDAI) Score

    Month 12

  • Percentage of Participants Achieving American College of Rheumatology (ACR) Response

    Month 12

  • Tender Joint Count (TJC)

    Month 12

  • Swollen Joint Count (SJC)

    Month 12

Secondary Outcomes (1)

  • Percentage of Participants with any Adverse Event (AE)

    Up to 36 months

Study Arms (1)

Rheumatoid arthritis participants

Rheumatoid arthritis participants receiving tocilizumab intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.

Drug: Tocilizumab

Interventions

TocilizumabDRUG

Tocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.

Also known as: RoActemra
Rheumatoid arthritis participants

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with rheumatoid arthritis will be enrolled in this trial.

You may qualify if:

  • \- Participants with rheumatoid arthritis receiving tocilizumab as per product label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bludenz, 6700, Austria

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2016

First Posted

March 28, 2016

Study Start

March 1, 2009

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

July 4, 2016

Record last verified: 2016-07

Locations

AU(1)