NCT01952509

Brief Summary

This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local label will be followed for 6 months.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2013

Typical duration for all trials

Geographic Reach
4 countries

6 active sites

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

First Submitted

Initial submission to the registry

September 10, 2013

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 30, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

2.9 years

First QC Date

September 10, 2013

Last Update Submit

November 1, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation

    approximately 2 years

Secondary Outcomes (10)

  • Rates of dose modifications/interruptions

    approximately 2 years

  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment

    approximately 2 years

  • Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6

    approximately 2 years

  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR

    approximately 2 years

  • Safety: Incidence of adverse events

    approximately 2 years

  • +5 more secondary outcomes

Study Arms (1)

Cohort

Eligibility Criteria

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

Patients with moderate to severe rheumatoid arthritis initiating treatment with RoActemra/Actemra in accordance with the local label

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

You may not qualify if:

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Patients who have received treatment with any 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Cartago, 0, Costa Rica

Location

Unknown Facility

San José, 0, Costa Rica

Location

Unknown Facility

Santo Domingo, 10208, Dominican Republic

Location

Unknown Facility

Guatemala City, Guatemala

Location

Unknown Facility

Panama City, 32400, Panama

Location

Unknown Facility

Panama City, Panama

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

September 10, 2013

First Posted

September 30, 2013

Study Start

October 1, 2013

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

CO(2)DO(1)GU(1)PA(2)