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
Verified date | November 2015 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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.
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 |
Observational Model: Cohort
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Italy,
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 |
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