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An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice (ACT SOLO)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01474291
First received: November 15, 2011
Last updated: September 8, 2016
Last verified: September 2016
  Purpose
This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.

Condition Intervention
Rheumatoid Arthritis
Biological: Tocilizumab

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion [ Time Frame: Day 1 ]
    The number of participants assigned to tocilizumab monotherapy versus tocilizumab combination therapy is reported. A multivariate analysis was performed to search for predictive factors for the initiation of tocilizumab in monotherapy.


Secondary Outcome Measures:
  • Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX) [ Time Frame: Day 1 (assessment of discontinuations within prior 2 years) ]

    The percentage of participants who discontinued MTX treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

    Reason for discontinuation "Other Intolerance" = intolerance other than cytopenia or hepatic cytolysis.


  • Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide [ Time Frame: Day 1 (assessment of discontinuations within prior 2 years) ]
    The percentage of participants who discontinued leflunomide treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

  • Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine [ Time Frame: Day 1 (assessment of discontinuations within prior 2 years) ]
    The percentage of participants who discontinued sulfasalazine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

  • Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine [ Time Frame: Day 1 (assessment of discontinuations within prior 2 years) ]
    The percentage of participants who discontinued hydroxychloroquine treatment prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

  • Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs) [ Time Frame: Day 1 (assessment of discontinuations within prior 2 years) ]
    The percentage of participants who discontinued treatment with unspecified csDMARDs prior to being assigned to tocilizumab monotherapy is presented by reason for discontinuation.

  • Mean Number of Tocilizumab Infusions Over the Study Period [ Time Frame: Up to 30 months ]
  • Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period [ Time Frame: Up to 13.4 months ]
    The percentage of participants who received infusions is presented by category of total infusions received over the study period.

  • Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period [ Time Frame: Up to 30 months ]
    The percentage of participants with no modifications (dose modification or discontinuation) is presented.

  • Percentage of Participants With at Least One csDMARD Intensification During the Study [ Time Frame: Up to 30 months ]
    csDMARD intensification was defined as an addition of a csDMARD without suppression of other csDMARD, dose increase of a csDMARD, switch (addition and suppression) of a csDMARD without intolerance, biological abnormality or symptom improvement to the suppressed csDMARD, or modification of the MTX administration route (from oral route to intramuscular/subcutaneous) with dose increase or maintenance.

  • Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12 [ Time Frame: Month 12 ]
    DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of ≤3.2 was considered to be DAS28-ESR LDA. Participants with missing data were considered to have failed to achieve the outcome.

  • Percentage of Participants With DAS28-ESR Remission at Month 12 [ Time Frame: Month 12 ]
    DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity. A score of <2.6 was considered to be DAS28-ESR remission. Participants with missing data were considered to have failed to achieve the outcome.

  • Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12 [ Time Frame: Month 12 ]
    CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient's global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤10 was considered to be CDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.

  • Percentage of Participants With CDAI Remission at Month 12 [ Time Frame: Month 12 ]
    CDAI was calculated from the number of swollen joints and tender joints using the 28-joint count and the patient's global assessment of disease activity and physician's global assessment of disease activity; CDAI scores range from 0 to 76, where lower scores indicate less disease activity. A score of ≤2.8 was considered to be CDAI remission. Participants with missing data were considered to have failed to achieve the outcome.

  • Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12 [ Time Frame: Month 12 ]
    SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, C-reactive protein (CRP) (milligrams per liter (mg/L)) per , and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤11 was considered to be SDAI LDA. Participants with missing data were considered to have failed to achieve the outcome.

  • Percentage of Participants With SDAI Remission at Month 12 [ Time Frame: Month 12 ]
    SDAI was calculated from the number of swollen joints and tender joints using the 28-joint count, CRP (mg/L), and the patient's global assessment of disease activity and physician's global assessment of disease activity; SDAI scores range from 0 to 86, where lower scores indicate less disease activity. A score of ≤3.3 was considered to be SDAI remission. Participants with missing data were considered to have failed to achieve the outcome.

  • Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12 [ Time Frame: Month 12 ]
    ACR20/50/70 response was calculated as improvement (from baseline) of at least 20/50/70% (respectively) of tender and of swollen joints, and improvement from baseline of least 20/50/70% (respectively) in at least 3 of the 5 following parameters: participant's pain assessment, patient's global assessment of disease activity, physician's global assessment of disease activity, health assessment questionnaire disability index (HAQ-DI) score, and ESR (mm/hour) or CRP (mg/L). Participants with missing data were considered to have failed to achieve the outcome.

  • Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12 [ Time Frame: Month 12 ]

    EULAR response was categorized as good or moderate response and was calculated as the difference between DAS28-ESR scores at baseline and Month 12. DAS28-ESR was calculated from the number of swollen joints and tender joints using the 28-joint count, ESR (mm/hour) and patient's global assessment of disease activity; scores range from 0 to 10, where lower scores indicate less disease activity.

    • If diminution from baseline >1.2 and score ≤3.2 at Month 12 = good response
    • If diminution from baseline >1.2 and score >3.2 at Month 12 = moderate response
    • If diminution from baseline >0.6 and ≤1.2, and score ≤5.1 at Month 12 = moderate response
    • If diminution from baseline >0.6 and ≤1.2, and score >5.1 at Month 12 = non-response
    • If diminution from baseline ≤1.2 at Month 12 = non-response
    • Participants with missing data were considered as non-response

  • Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score [ Time Frame: Baseline; Month 6; Month 12 ]
    The HAQ-DI is a participant-reported assessment of ability to perform daily living activities. This composite index score ranges from 0 (normal) to 3 (total functional disability) and includes questions regarding 8 domains (dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week). A decrease in score corresponds to improvement in participant-assessed health state.

  • Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score [ Time Frame: Baseline; Month 6, Month 12 ]
    The RAID questionnaire is a participant-reported outcome measure evaluating the impact of rheumatoid arthritis on participant quality of life. This composite index score ranges from 0 (best) to 10 (worst) and includes questions regarding 7 domains (pain, functional disability assessment, fatigue, sleep, physical well-being, emotional well-being, coping). A decrease in score corresponds to improvement in participant-assessed health state.

  • Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire. [ Time Frame: Baseline; Month 6; Month 12 ]
    Participants were asked: "If you were to remain in the same condition for the next few months as you have been over the last 8 days, would this be 1) acceptable, 2) unacceptable?" The percentage of participants who responded "acceptable" at each time point is presented.

  • Percentage of Participants With Adverse Events [ Time Frame: Up to 30 months ]
    An adverse event was defined as any unfavorable and unintended sign (including an abnormal laboratory finding if accompanied by clinical symptoms, results in a change in study treatment, results in a medical intervention or a change in concomitant therapy or clinically significant in the investigator's judgment), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.


Enrollment: 608
Study Start Date: January 2012
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tocilizumab
Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
Biological: Tocilizumab
Tocilizumab administered according to prescribing information and normal clinical practice.
Other Names:
  • RoActemra®
  • Actemra®

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Moderate to severe rheumatoid arthritis participants treated with tocilizumab in routine clinical practice
Criteria

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Patients with rheumatoid arthritis for whom the rheumatologist decides to start tocilizumab in combination with DMARD or as monotherapy

Exclusion Criteria:

  • Current participation in a clinical trial in rheumatoid arthritis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474291

  Show 119 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01474291     History of Changes
Other Study ID Numbers: ML27873
Study First Received: November 15, 2011
Results First Received: September 8, 2016
Last Updated: September 8, 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 25, 2017