N/A
N=304
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
Bottom Line
View on ClinicalTrials.gov: NCT01791205 ↗Enrolled (actual)
304
Serious AEs
4.8%
Results posted
Jan 2017
Primary outcome: Primary: Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy — 79; 75; 73; 77 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy |
79; 75; 73; 77; 152; 150 | — |
| PRIMARY Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy |
74; 81; 78; 71 | — |
| PRIMARY Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy |
121; 116 | — |
| PRIMARY Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy |
69; 79; 59; 49; 61; 72 | — |
| PRIMARY Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy |
42; 40; 42; 40 | — |
| PRIMARY Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy |
67; 55; 54; 67 | — |
| PRIMARY Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy |
66; 64; 62; 65; 80; 59 | — |
| PRIMARY Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy |
37; 39; 37; 38 | — |
| PRIMARY Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy |
36; 35; 36; 34 | — |
| PRIMARY Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy |
45; 33; 36; 41; 36; 26 | — |
| PRIMARY Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy |
106; 46 | — |
| PRIMARY Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy |
95; 125; 57; 27 | — |
| PRIMARY Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy |
30; 40; 74; 56; 81; 75 | — |
| PRIMARY Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy |
41; 68; 7; 5; 4; 3 | — |
| PRIMARY Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy |
99.0; 97.1; 96.2; 95.2; 94.2; 93.3 | — |
| PRIMARY Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18 |
64.71; 80.39 | 0.1194 |
| SECONDARY Phase I: Median Disease Duration in Monotherapy and Combination Therapy |
125; 114 | 0.3895 |
| SECONDARY Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy |
79.61; 76.32 | 0.4900 |
| SECONDARY Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy |
0.873; 0.915 | 0.6908 |
| SECONDARY 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 |
49.01; 35.81 | 0.0210 sig |
| SECONDARY Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines |
71; 35; 35; 6; 4; 1 | — |
| SECONDARY Phase I: Number of Participants With at Least One Previous Treatment With Biologics Drug as a Monotherapy in Monotherapy and Combination Therapy |
57; 27 | — |
| SECONDARY Phase I: Percentage of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy |
19.74; 26.32; 48.68; 36.84; 53.29; 49.34 | — |
| SECONDARY Phase I: Median DAS28 at Study Entry in Monotherapy and Combination Therapy |
2.51; 2.77 | — |
| SECONDARY Phase I: Number of Participants With CDAI Scores at Study Entry in Monotherapy and Combination Therapy |
18; 16; 28; 30; 20; 21 | — |
| SECONDARY Phase I: Number of Participants With SDAI Scores at Study Entry in Monotherapy and Combination Therapy |
19; 17; 25; 26; 22; 20 | — |
| SECONDARY Phase I: Mean Tender Joints and Swollen Joints as Disease Activity at Study Entry in Monotherapy and Combination Therapy |
2.49; 2.71; 1.29; 1.20 | — |
| SECONDARY Phase I: Percentage of Participants Treated With Corticosteroids at Study Entry in Monotherapy and Combination Therapy |
46.05; 55.26 | — |
| SECONDARY Phase I: Mean Dose of Corticosteroids At Study Entry in Monotherapy and Combination Therapy |
4.64; 4.71 | — |
| SECONDARY Phase I: Mean Duration of Previous Treatment With a Biologic Drug in Monotherapy and Combination Therapy |
1254.7; 1188.3 | — |
| SECONDARY Phase I: Mean Duration of Treatment With A Biologic Drug in Combination With DMARDs Before Monotherapy |
1486.1; 1525.9 | — |
| SECONDARY Phase II: Percentage of Participants Maintaining Delta DAS 28 CRP of >= 0.6 at Months 3, 6, 12, and 18 |
55.36; 56.6; 60.78; 60 | — |
| SECONDARY Phase II: Percentage of Participants Maintaining Delta DAS28 ESR >= 0.6 at Months 3, 6, 12, and 18 |
55.00; 67.86; 58.82; 72.55 | — |
| SECONDARY Phase II: Percentage of Participants Achieving DAS28 CRP Remission (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18 |
18.18; 43.1; 64.15; 60.78; 32.73; 67.24 | — |
| SECONDARY Phase II: Percentage of Participants Achieving DAS 28 ESR (< 2.6) and Low Disease Activity (<3.2) at Months 3, 6, 12, and 18 |
14.04; 42.62; 53.57; 64.71; 24.56; 70.49 | — |
| SECONDARY Phase II: Percentage of Participants Achieving CDAI Remission (< 2.8) at Months 3, 6, 12, and 18 |
11.11; 16.67; 33.33; 31.58 | — |
| SECONDARY Phase II: Percentage of Participant Achieving SDAI Remission (< 3.3) at Months 3, 6, 12, and 18 |
12.5; 22.22; 50.00; 36.36 | — |
| SECONDARY Phase II: Mean Change From Baseline in TJC And SJC at Months 3, 6, 12, and 18 |
-2.74; -4.13; -4.33; -4.30; -1.65; -2.39 | — |
| SECONDARY Phase II: Mean Change From Baseline in Dose of Corticosteroids at Months 3, 6, 12, and 18 |
-0.85; -1.24; -1.71; -1.08 | — |
| SECONDARY Phase II: Percentage of Participants With Delta HAQ >= 0.21 at Months 3, 6, 12, and 18 |
8.51; 10.00; 13.89; 8.11 | — |
| SECONDARY Phase II: Mean VAS Fatigue Score Overtime |
54.95; 40.58; 30.42; 33.82; 23.35 | — |
| SECONDARY Phase II: Number of Participants With Any Adverse Events, Any Serious Adverse Events, Adverse Events of Special Interest, and Tubercular Events |
56; 5; 10; 0 | — |
| SECONDARY Phase II: Number of Participants With Retention in Therapy Without Interruption Due to Side Effects |
103 | — |
| SECONDARY Phase II: Number of Side Effects That Had Not Induced Discontinuation of Treatment |
19 | — |
| SECONDARY Phase II: Number of Side Effects That Induced Transient Interruption of Treatment |
15 | — |
| SECONDARY Phase II: Mean Change From Baseline in Hemoglobin Levels Over Time |
0.41; 0.34; 0.44; 0.49 | — |
| SECONDARY Phase II: Mean Change From Baseline in Hematocrit, Neutrophils, Eosinophils, Basophils, Lymphocytes, and Monocytes Over Time |
5.73; -0.11; 0.32; -0.35; -7.82; -7.69 | — |
| SECONDARY Phase II: Mean Change From Baseline in Red Blood Cells, White Blood Cells, and Platelets Over Time |
0.07; -0.01; 0.04; 0.05; -1.14; -1.30 | — |
| SECONDARY 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 |
10.04; 12.61; 4.81; 5.57; -3.63; 13.93 | — |
| SECONDARY Phase II: Mean Change From Baseline in Aspartate Transaminase, Alanine Transaminase, Gamma-glutamyl Transpeptidase, and Alkaline Phosphatase Levels Over Time |
0.75; 0.87; 0.78; 1.53; 3.08; 0.60 | — |
| SECONDARY Phase II: Mean Change From Baseline in Serum Electrophoresis Parameters Over Time |
3.92; 5.23; 5.35; 5.95; -0.85; -1.09 | — |
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
Data sourced from ClinicalTrials.gov (NCT01791205). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.