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

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-Center Observational Study on the Use of Biologic Drugs as Monotherapy or Combination With DMARDs in Patients With Rheumatoid Arthritis in Italian Clinical Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01791205
• Other study ID #: ML28552
• Status: Completed
• Phase: N/A
• First received: February 12, 2013
• Last updated: November 2, 2015
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: November 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical Trial 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 associated with the use of a biologic drug in monotherapy as compared to therapy in combination with DMARDs will be evaluated. In the retrospective/prospective Part 2 of the study, efficacy and safety of the use of RoActemra/Actemra (tocilizumab) in monotherapy will be evaluated. Patients will be followed for up to18 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Part 1:

• Adult patients, >/= 18 years of age

• Diagnosis of rheumatoid arthritis according to ACR/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 Criteria:

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Clinical/demographic factors associated with the use of biologic drugs in monotherapy		at baseline	No
Primary	Part 2: Percentage of patients on RoActemra/Actemra monotherapy 18 months after first infusion as monotherapy, in correlation with selected variables (duration of disease, autoantibody status, prior biologic therapy, disease activity, corticosteroid use)		18 months	No
Secondary	Patient reported outcomes (Health Assessment Questionnaire, Visual Analogue Scale)		18 months	No
Secondary	Safety: Incidence of adverse events (AEs), serious AEs, AEs of special interest		18 months	No
Secondary	Change in Disease Activity Score DAS28 from first infusion of RoActemra/Actemra in monotherapy		from baseline to Month 18	No
Secondary	Rate of patients achieving low disease activity (Clinical Disease Activity Index (CDAI) score </= 2.8) at 3, 6, 12 and 18 months from first infusion of RoActemra/Actemra in monotherapy		18 months	No
Secondary	Rate of patients achieving remission (Simplified Disease Activity Index (SDAI) score </= 3.3) at 3, 6, 12 and 18 months after first infusion of RoActemra/Actemra in monotherapy		18 months	No
Secondary	Reduction in tender/swollen joint count (TJC/SJC)		from baseline to Month 18	No
Secondary	Corticosteroid dose reductions		from baseline to Month 18	No