Status:

COMPLETED

ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Rheumatoid Arthritis

Eligibility:

All Genders

18+ years

Brief Summary

This is a multicenter observational study in patients with rheumatoid arthritis in routine clinical practice in Italy. In the retrospective Part 1 of the study, clinical and demographic factors associ...

Eligibility Criteria

Inclusion

  • Part 1:
  • Adult patients, \>/= 18 years of age
  • Diagnosis of rheumatoid arthritis according to American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) criteria
  • Patients who received at least one cycle of biologic therapy, either in monotherapy or in combination, in the 12 months preceding the opening of the first site
  • Part 2:
  • Patients on monotherapy with RoActemra/Actemra already enrolled in Part 1 of the study

Exclusion

  • Patients simultaneously participating in other studies with RoActemra/Actemra at the time of signing informed consent

Key Trial Info

Start Date :

May 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

October 1 2014

Estimated Enrollment :

304 Patients enrolled

Trial Details

Trial ID

NCT01791205

Start Date

May 1 2013

End Date

October 1 2014

Last Update

January 10 2017

Active Locations (28)

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Page 1 of 7 (28 locations)

1

Bari, Apulia, Italy, 70124

2

Martina Franca, Apulia, Italy, 74015

3

Reggio Calabria, Calabria, Italy, 89133

4

Napoli, Campania, Italy, 80131

ARMONIA: An Observational Study of Biologic Drugs in Monotherapy or Combination With DMARDs in Italian Clinical Practice and the Efficacy and Safety of RoActemra/Actemra (Tocilizumab) Monotherapy in Patients With Rheumatoid Arthritis | DecenTrialz