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A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy

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ClinicalTrials.gov Identifier: NCT01705730
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : September 3, 2018
Last Update Posted : September 3, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Drug: tocilizumab

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Study Type : Observational
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy
Actual Study Start Date : July 31, 2012
Actual Primary Completion Date : December 12, 2014
Actual Study Completion Date : December 12, 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab

Group/Cohort Intervention/treatment
Tocilizumab
Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Drug: tocilizumab
Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
Other Name: Actemra




Primary Outcome Measures :
  1. Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation [ Time Frame: Month 6 after treatment initiation ]

Secondary Outcome Measures :
  1. Percentage of Participants With Systemic Manifestations of RA at Baseline [ Time Frame: Baseline ]
    Systemic manifestations of RA included anemia, fatigue, conventional risk factors for cardiovascular disease, C-Reactive Protein (CRP) above upper limit of normal, rheumatoid nodules, rheumatoid vasculitis and interstitial lung disease. Participants were included if they experienced at least any one of the conditions.

  2. Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response [ Time Frame: Baseline ]
  3. Number of Participants With Inadequate Response to Other Biologics [ Time Frame: Baseline ]
  4. Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs) [ Time Frame: Month 6 ]
    The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.

  5. Percentage of Participants Who Had DMARDs During Study [ Time Frame: Month 6 ]
  6. Number of Participants With Dose Reductions [ Time Frame: 6 months ]
  7. Number of Participants With Starting Tocilizumab After Failing DMARDs [ Time Frame: Baseline ]
  8. Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents [ Time Frame: Baseline ]
  9. Time to Reduction/Withdrawal of Corticosteroids [ Time Frame: Month 6 ]
  10. Number of Dose Modifications Per Participant at Month 6 [ Time Frame: Month 6 ]
    Number of dose modification per participant at Month 6 was reported.

  11. Mean Dosing Interval Per Participant at Month 6 [ Time Frame: Month 6 ]
  12. Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy [ Time Frame: Month 6 ]
  13. Time for Restoration of Initial Dosing Regimen [ Time Frame: Month 6 ]
  14. Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen [ Time Frame: Month 6 ]
  15. Number of Participants Who Were Not Adhering to Recommended Management of AEs [ Time Frame: Month 6 ]
  16. Percentage of Participants Still on Tocilizumab Monotherapy at Month 6 [ Time Frame: Month 6 ]
  17. Percentage of Participants With Reason for Choice of Monotherapy at Baseline [ Time Frame: Baseline ]
  18. Tender Joint Count (TJC) [ Time Frame: Baseline, Month 3, 6 ]
    TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1.

  19. Swollen Joint Count (SJC) [ Time Frame: Baseline, Month 3, 6 ]
    SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.

  20. Percentage of Participants With Disease Activity Score-28 (DAS28) [ Time Frame: Baseline, Month 3, 6 ]
    DAS28 was calculated from SJC and TJC using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour [mm/hr]), and patient global assessment of disease activity (PGH) (measured on a 0 to 100 millimeter (mm) Visual Analogue Scale (VAS) where 0=no disease activity and 100=worst disease activity). DAS28 is a measurement of RA activity on a 0 to 10 scale: a score greater than (>) 5.1 indicates high disease activity; a score between 3.2 and 5.1 indicates moderate disease activity; a score of less than 3.2 indicates low disease activity; a score of less than (<) 2.6 is considered remission.

  21. Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 [ Time Frame: Month 3, 6 ]
    Clinical response assessed as per EULAR categorical DAS28 response criteria was defined as clinically meaningful improvement at a particular time point. EULAR response was based on change from baseline (CFB) in the DAS28 score and also on the actual DAS28 score at the time point so was more reflective of the current status of the participant. EULAR Good response: DAS28 <=3.2 and a CFB <-1.2. EULAR Moderate response: DAS28 >3.2 to ≤ 5.1 or a CFB < -0.6 to ≥ -1.2. EULAR No response: DAS28 ≤3.2 or CFB greater than or equal to (>=) -0.6, DAS28 >3.2 to <=5.1 or CFB>=-0.6 and DAS28 >5.1 or CFB >=-0.6. The DAS28 score was a measure of the participant's disease activity, based on the TJC (28 joints), SJC (28 joints), PGH, and ESR. DAS28 total scores ranged from 0 to approximately 10. Scores <2.6 = best disease control and scores >5.1 = worse disease control. A negative CFB indicated clinically meaningful improvement.

  22. Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 [ Time Frame: Month 3, 6 ]
    ACR response was calculated based on total joint count evaluation (28 or 66/68 joint count) and other clinical and laboratory assessments. A positive ACR20 response required at least a 20% improvement (reduction) compared to baseline in swollen joint count (66 joints) and tender joint count (68 joints) and at least 3 of the following 5 assessments: patient's global assessment of pain, PGH, PhGH (all 3 assessed at 0 [good] to 100 mm [worst] VAS scale), participant assessment of disability measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI) (assessed on a 0 to 3 scale, where higher scores represented higher disease activity), Acute phase reactant (CRP or ESR). A reduction in the level of and acute phase reactants was considered an improvement. ACR50, ACR70, ACR90 require a 50%, 70%, 90% improvement from baseline respectively.

  23. Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response [ Time Frame: Baseline, Month 3, 6 ]
    CDAI is the numerical sum of 4 outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and physician global assessment of disease activity (PhGH) assessed on 0-10 cm VAS; 0 = no disease activity and 10 = worst disease activity. CDAI total score = 0-76. CDAI <= 2.8 indicates clinical remission, >2.8 to 10 = low disease activity, >10 to 22 = moderate disease activity, and >22 = high (or severe) disease activity.

  24. Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response [ Time Frame: Baseline, Month 3, 6 ]
    The SDAI was a combined index for measuring disease activity in RA which reflected the numerical sum of five outcome parameters: TJC and SJC based on a 28-joint assessment, PGH and PhGH, assessed on 0-100 mm VAS where 0 = no disease activity and 100 = worst disease activity, and C-reactive protein (CRP). SDAI total score = 0-86. A SDAI score </= 3.3 represented clinical remission, a score of between 3.4 and 11.0 represented low disease activity, a score between 11 and 26.0 represented moderate disease activity and a score > 26.0 represented high (or severe) disease.

  25. Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, 6 ]
    The Patient Global Assessment of disease activity provides an overall assessment of how RA affects the participant using a visual analogue score, where 0 indicates they are managing very well and 100 indicates they are managing very poorly. A decrease in the score indicates improvement.

  26. Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, 6 ]
    The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). A negative change from Baseline indicated improvement.

  27. Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, 6 ]
    The HAQ was a participant self-reported questionnaire for assessing the extent of a participant's functional ability. It consisted of 20 questions in 8 categories (dressing and grooming, rising, eating, walking, reach, grip, hygiene, and carrying out daily activities). Each question had 4 response options, ranging from 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. The HAQ scale was an average of all the scores and ranged from 0 to 3, where higher scores represented higher disease activity.

  28. Change From Baseline in VAS-Fatigue at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, 6 ]
    The VAS-fatigue provides an overall assessment of the level of fatigue that the participant is experiencing using a visual analogue score, where 0 indicates no fatigue and 100 indicates extreme fatigue. A decrease in the score indicates improvement.

  29. Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, 6 ]
    The Patient Global Assessment of pain provides an overall assessment of the severity of pain that the participant is experiencing using a visual analogue score, where 0 indicates no pain and 100 indicates unbearable pain. A decrease in the score indicates improvement.

  30. Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6 [ Time Frame: Baseline, Month 3, 6 ]
    Morning stiffness was defined by the time elapsed between the time of usual awakening (even if not in the morning) and the time the participant was as limber as he/she would be during a day involving typical activities. Morning stiffness was assessed on a 100 mm VAS, where 0= none and 100= very severe.

  31. Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) [ Time Frame: Month 6 ]
    An AE was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect. AESI included- serious/medically significant infections; myocardial Infarction/acute coronary syndrome; gastrointestinal perforations; malignancies; anaphylaxis/hypersensitivity reactions; demyelinating disorders; stroke; serious/medically significant bleeding events; serious/medically significant hepatic events.

  32. Percentage of Participants With AEs Leading to Dose Modifications [ Time Frame: Month 6 ]
  33. C-reactive Protein (CRP]) Level [ Time Frame: Baseline, Month 3, 6 ]
    CRP is an acute phase reactant and is a measure of inflammation.

  34. Erythrocyte Sedimentation Rate (ESR) Level [ Time Frame: Baseline, Month 3, 6 ]
    ESR is an acute phase reactant and is a measure of inflammation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in monotherapy
Criteria

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
  • Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
  • Concomitant treatment with NSAIDs and/or corticosteroids is allowed

Exclusion Criteria:

  • Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
  • Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
  • Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
  • Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705730


Locations
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Belgium
ASZ Aalst
Aalst, Belgium, 9300
CH EpiCURA Site Ath
Ath, Belgium, 7800
CHU Brugmann (Victor Horta)
Bruxelles, Belgium, 1020
Hospital Erasme; Neurologie
Bruxelles, Belgium, 1070
Reumaclinic
Genk, Belgium, 3600
GHdC Site Saint-Joseph
Gilly (Charleroi), Belgium, 6000
Clinique Notre Dame de Grâce
Gosselies, Belgium, 6041
CH Jolimont - Lobbes (Jolimont)
Haine-Saint-Paul, Belgium, 7100
AZ Groeninge
Kortrijk, Belgium, 8500
Chr de La Citadelle
Liège, Belgium, 4000
Clinique Saint-Joseph
Liège, Belgium, 4000
CHU Ambroise Paré
Mons, Belgium, 7000
AZ Damiaan
Oostende, Belgium, 8400
Clinique St Pierre asbl
Ottignies, Belgium, 1340
AZ Delta (Campus Wilgenstraat)
Roeselare, Belgium, 8800
AZ Turnhout Sint Jozef
Turnhout, Belgium, 2300
Sint Augustinus Wilrijk
Wilrijk, Belgium, 2610
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01705730     History of Changes
Other Study ID Numbers: ML28269
First Posted: October 12, 2012    Key Record Dates
Results First Posted: September 3, 2018
Last Update Posted: September 3, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases