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

NCT01791205 | Completed Results

• 1 other identifier: ML28552
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 28

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (16)

• Phase I: Number of Participants With Demographic Characteristics in Monotherapy and Combination Therapy

  Demographic characteristics were analyzed in participants at Baseline, where Baseline is considered as the study entry visit (day of informed consent form signed). Demographic characteristics which were taken into account included age in years, race, height in centimeters (cm), weight in Kilograms (Kg), and Body Mass Index (BMI) in Kg/cm\^2. Participants with age =\<, \> 59 years, height =\<, \> 163 cm, weight =\<, \> 65.85 Kg and BMI =\<, \> 24.98 Kg/cm\^2 are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Disease Duration in Monotherapy and Combination Therapy

  The duration of disease is defined as the total time from the diagnosis of rheumatoid arthritis (RA) until the study entry.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Comorbidity in Monotherapy and Combination Therapy

  Comorbidity is the presence of previous or concomitant diseases.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Autoantibody Status (Rheumatoid Factor and Anti-cyclic Citrullinated Protein Antibodies) in Monotherapy and Combination Therapy

  The autoantibody included seropositive or seronegative participants for rheumatoid factor (RF) and/or anti-cyclic citrullinated protein antibodies (Anti-CCP). RF value higher than 20 Units (U)/milliliter (mL) is considered seropositive and anti-CCP antibodies value higher than 10 U/mL is considered positive.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Health Assessment Questionnaire- Disability Index in Monotherapy and Combination Therapy

  The Health Assessment Questionnaire- Disability Index (HAQ-DI) is a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatoid arthritis. It consisted of 20 questions in eight domains (dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities) rated on a 4-point scale, where 0 (equals) = without difficulties; 1= with some difficulties; 2= with great difficulties; and 3= unable to perform these actions at all. The HAQ-DI scale was an average of all the scores and ranged from 0 (mild disability) to 3 (severe disability), where higher scores represents higher disease activity. Participants assessed their ability to do each task over the past seven days. Participants with scores =\< 0.8625 and \> 0.8625 are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Disease Activity Score 28 in Monotherapy and Combination Therapy

  The disease activity included Disease Activity Score 28 (DAS28). The DAS28 is a combined index for measuring disease activity in RA. The index includes swollen joint counts (SJC) and tender joint counts (TJC), acute phase response, and general health status. The DAS28 scale ranges from 0 to 10 (0= no disease activity and 10= maximum disease activity; where higher scores represents higher disease activity. The DAS =\< 2.8 indicates clinical remission, \>2.8 to 10 = low disease activity, \>10 to 22 = moderate disease activity, and \>22 = high disease activity. Participants with DAS28 score =\< 2.6 and \> 2.6 are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With C-Reactive Protein Value and Erythrocyte Sedimentation Rate in Monotherapy and Combination Therapy

  The disease activity included biological markers of inflammation: C-Reactive Protein (CRP) and Erythrocyte Sedimentation Rate (ESR). A reduction in CRP and ESR values indicates improvement. Participants with CRP values =\< 0.28 and \>2.8 milligram/deciliter (mg/dL); and ESR values =\< 11 and \>11 millimeters/hour (mm/hr) are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Clinical Disease Activity Index in Monotherapy and Combination Therapy

  The disease activity included Clinical Disease Activity Index (CDAI) which is the numerical sum of four outcome parameters: TJC and SJC based on a 28-joint assessment; and patient's global assessment (PtGA) and physician's global assessment (PhGA) assessed on 0-10 cm visual analog scale (VAS), where 0 = no disease activity and 10 = worst disease activity, where higher scores represents higher disease activity. The CDAI total score ranges from 0 (no disease activity) to 76 (maximal disease activity), where higher scores represents higher disease activity. The CDAI =\< 2.8 indicates clinical remission, \> 2.8 to 10 indicates low disease activity, \> 10 to 22 indicates moderate disease activity, and \> 22 indicates high disease activity. Participants with CDAI score =\< 7.75 and \> 7.75 are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Simplified Disease Activity Index in Monotherapy and Combination Therapy

  The disease activity included Simplified Disease Activity Index (SDAI) which is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\< 3.3 indicates disease remission, \> 3.4 to 11 indicates low disease activity, \> 11 to 26 indicates moderate disease activity, and \> 26 indicates high disease activity. Participants with SDAI score =\< 8.17 and \> 8.17 are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Duration of Combination Therapy Before Monotherapy in Monotherapy and Combination Therapy

  The duration of combination therapy before monotherapy are reported. The duration was estimated by calculating total duration from starting the combination therapy till the participant switched to monotherapy. Participants who started the combination therapy and later switched to monotherapy =\< 337 days, \> 337 days, =\< 336 days, \> 336 days are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants Treatment Line in Which Monotherapy Has Been Adopted in Monotherapy

  The first biologic treatment line was defined as the first use of any biologic drug in treatment of rheumatoid arthritis, regardless its association with DMARDs and the second treatment line as the subsequent use of a different biologic drug. Participants who adopted monotherapy as =\< 2 and \> 2 therapy lines are reported. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Biologics Administered as Monotherapy in Monotherapy and Combination Therapy

  Participants who received at least one previous treatment with biologics in monotherapy and no previous monotherapy with biologics are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Prevalence of Previous Therapy Switches and Swaps in Monotherapy and Combination Therapy

  Participants who had prevalence with at least one previous switch, swaps, and switch/swap to other therapy are reported.

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants With Reasons Leading to the Use of Biologic in Monotherapy

  Reasons leading to the use of biologic in monotherapy includes DMARDs intolerance, insufficient therapeutic effect, intolerance to biologic drug, low participant's compliance, concomitant pathologies, pregnancy desire, remission from combination therapy, remission from monotherapy, others and unknown. Participants with reason leading to the use of biologic in monotherapy are presented. According to the study protocol objectives, this analysis was performed only for Monotherapy arm.

  At Baseline (Day of informed consent form signed)

• Phase II: Percentage of Participants Who Retained on Tocilizumab Monotherapy

  The probabilities of participant to retain on therapy at various time points are reported.

  Up to 18 months

• Phase II: Retention Rate in Therapy, Percentage of Participants Achieving DAS 28 ESR <2.6 and <3.2 at Month 18

  Participants who retained the therapy were analyzed for disease activity (DAS28 ESR) at Month 18. The DAS28 ESR is a measure of the participant's disease activity calculated using TJC (28 joints), SJC (28 joints), PtGA using 0-10 cm VAS (0 = no disease activity and 10 = worst disease activity), and ESR. It is calculated by using the following formula: DAS28 ESR = 0.56 x square root of TJC + 0.28 x square root of SJC + 0.70 x log n at ESR + 0.014 x PtGA. The DAS28 ESR scores ranged from 0.49 (less disease activity) to 9.07 (maximal disease activity); decrease in score indicated improvement of disease.

  At month 18

Secondary Outcomes (35)

• Phase I: Median Disease Duration in Monotherapy and Combination Therapy

  At Baseline (Day of informed consent form signed)

• Phase I: Percentage of Participants With Comorbidity in Monotherapy and Combination Therapy

  At Baseline (Day of informed consent form signed)

• Phase I: Mean Health Assessment Questionnaire-Disability Index in Monotherapy and Combination Therapy

  At Baseline (Day of informed consent form signed)

• 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

  At Baseline (Day of informed consent form signed)

• Phase I: Number of Participants Receiving a Biologic Drug as Monotherapy at Different Treatment Lines

  At Baseline (Day of informed consent form signed)

Study Arms (2)

Monotherapy

Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry will be observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy will be observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.

Combination Therapy

Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry will be observed for Phase I.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (28)

Unknown Facility

Bari, Apulia, 70124, Italy

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Martina Franca, Apulia, 74015, Italy

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Reggio Calabria, Calabria, 89133, Italy

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Napoli, Campania, 80131, Italy

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Telese Terme, Campania, 82037, Italy

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Bologna, Emilia-Romagna, 40138, Italy

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Rome, Lazio, 00133, Italy

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Rome, Lazio, 00152, Italy

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Rome, Lazio, 00161, Italy

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Rome, Lazio, 00189, Italy

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Legnano, Lombardy, 20025, Italy

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Milan, Lombardy, 20157, Italy

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Milan, Lombardy, 20162, Italy

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Monza, Lombardy, 20052, Italy

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Pavia, Lombardy, 27100, Italy

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Turin, Piedmont, 10126, Italy

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Turin, Piedmont, 10128, Italy

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Sassari, Sardinia, 07100, Italy

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Ancona, The Marches, 60020, Italy

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Iesi, The Marches, 60035, Italy

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Florence, Tuscany, 50139, Italy

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Pisa, Tuscany, 56100, Italy

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Prato, Tuscany, 59100, Italy

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Siena, Tuscany, 53100, Italy

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Perugia, Umbria, 06122, Italy

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Cona (Ferrara), Veneto, 44124, Italy

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Padua, Veneto, 35128, Italy

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Verona, Veneto, 37126, Italy

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 13, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 10, 2017
• Results First Posted: January 10, 2017

Record last verified: 2016-11

Locations

IT (28)