NCT01277328

Brief Summary

This observational, prospective, open-label, multi-center study will evaluate the effectiveness in disease reduction and the safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 11 months.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

4.3 years

First QC Date

January 13, 2011

Last Update Submit

September 14, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Mean change in Disease Activity Score 28 (DAS28)

    11 months

Secondary Outcomes (5)

  • Proportion of patients with a change in Disease Activity Score 28 (DAS28)

    5 months

  • European League Against Rheumatism (EULAR) response rates

    20 weeks

  • Proportion of patients with disease remission

    20 weeks

  • Proportion of patients with low disease activity

    20 weeks

  • Incidence of adverse events

    11 months

Study Arms (1)

Cohort

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with rheumatoid arthritis receiving RoActemra/Actemra

You may qualify if:

  • Adult patients \>/=18 years of age
  • Patients with rheumatoid arthritis eligible for RoActemra

You may not qualify if:

  • Hypersensitivity to RoActemra
  • Active, severe infections

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bucharest, 020983, Romania

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

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
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 14, 2011

Study Start

May 1, 2010

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

September 15, 2016

Record last verified: 2016-09

Locations

RO(1)