Clinical trial NCT01791205: 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
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 (ARMONIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-02-13
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis who have received at least one cycle of therapy with a biologic drug in monotherapy or in combination with DMARDs

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 associated with the use of a biologic drug in monotherapy as compared to therapy in combination with Disease-modifying anti-rheumatic drugs (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.


Eligibility criteria: Inclusion Criteria:

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 Criteria:

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

Primary outcomes:
measure: Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy
timeFrame: Up to 18 months
measure: Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18
timeFrame: At month 18
Secondary outcomes:
measure: Phase I: Median Disease Duration in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Percentage of Participants Who Started Treatment With a Biologic Drug in Monotherapy and Percentage of Participants Who Stopped a DMARDs While Taking a Biologic Drug in Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy
timeFrame: At Baseline (Day of informed consent form signed)
measure: Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18
timeFrame: At Months 3, 6, 12, and 18
measure: Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18
timeFrame: At Months 3, 6, 12, and 18
measure: Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18
timeFrame: At Months 3, 6, 12, and 18
measure: Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18
timeFrame: At Months 3, 6, 12, and 18
measure: Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18
timeFrame: At Months 3, 6, 12, and 18
measure: Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18
timeFrame: At Months 3, 6, 12, and 18
measure: Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18
timeFrame: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
measure: Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18
timeFrame: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
measure: Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18
timeFrame: At Months 3, 6, 12, and 18
measure: Phase II: Mean VAS Fatigue Score Overtime
timeFrame: At Baseline (Day of first administration of TCZ as a monotherapy) and Months 3, 6, 12, and 18
measure: Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events
timeFrame: Up to 18 months
measure: Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects
timeFrame: Up to 18 months
measure: Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment
timeFrame: Up to 18 months
measure: Phase II: Number of Side Effects That Induced Transient Interruption of Treatment
timeFrame: Up to 18 months
measure: Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time
timeFrame: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
measure: Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time
timeFrame: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
measure: Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time
timeFrame: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
measure: Phase II: Mean Change From Baseline in Total Cholesterol, Low-density and High-density Lipoprotein Cholesterol, Triglycerides, Total Bilirubin, Direct Bilirubin, Glucose, Creatinine, Blood Urea Nitrogen Levels Over Time
timeFrame: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
measure: Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time
timeFrame: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
measure: Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time
timeFrame: From Baseline (Day of first administration of TCZ as a monotherapy) to Months 3, 6, 12, and 18
Other outcomes:
Locations:
city: Reggio Calabria
country: Italy
state: Calabria
city: Napoli
country: Italy
state: Campania
city: Telese Terme
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Legnano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Jesi
country: Italy
state: Marche
city: Torino
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Martina Franca
country: Italy
state: Puglia
city: Sassari
country: Italy
state: Sardegna
city: Firenze
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Prato
country: Italy
state: Toscana
city: Siena
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Cona (Ferrara)
country: Italy
state: Veneto
city: Padova
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: