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

Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: tocilizumab

• Study Type: Observational
• Enrollment (Actual): 71

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • ASZ Aalst
  • Ath, Belgium, 7800
    • CH EpiCURA Site Ath
  • Bruxelles, Belgium, 1020
    • CHU Brugmann (Victor Horta)
  • Bruxelles, Belgium, 1070
    • Hospital Erasme; Neurologie
  • Genk, Belgium, 3600
    • ReumaClinic
  • Gilly (Charleroi), Belgium, 6000
    • GHdC Site Saint-Joseph
  • Gosselies, Belgium, 6041
    • Clinique Notre Dame de Grâce
  • Haine-Saint-Paul, Belgium, 7100
    • CH Jolimont - Lobbes (Jolimont)
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Liège, Belgium, 4000
    • CHR de la Citadelle
  • Liège, Belgium, 4000
    • Clinique Saint-Joseph
  • Mons, Belgium, 7000
    • CHU Ambroise Pare
  • Oostende, Belgium, 8400
    • AZ Damiaan
  • Ottignies, Belgium, 1340
    • Clinique St Pierre asbl
  • Roeselare, Belgium, 8800
    • AZ Delta (Campus Wilgenstraat)
  • Turnhout, Belgium, 2300
    • AZ Turnhout Sint Jozef
  • Wilrijk, Belgium, 2610
    • Sint Augustinus Wilrijk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in monotherapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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 Names: Actemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation	Month 6 after treatment initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Systemic Manifestations of RA at 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.	Baseline
Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response		Baseline
Number of Participants With Inadequate Response to Other Biologics		Baseline
Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)	The time to DMARD addition equals to the time (days) between tocilizumab start and first start date of DMARDs.	Month 6
Percentage of Participants Who Had DMARDs During Study		Month 6
Number of Participants With Dose Reductions		6 months
Number of Participants With Starting Tocilizumab After Failing DMARDs		Baseline
Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents		Baseline
Time to Reduction/Withdrawal of Corticosteroids		Month 6
Number of Dose Modifications Per Participant at Month 6	Number of dose modification per participant at Month 6 was reported.	Month 6
Mean Dosing Interval Per Participant at Month 6		Month 6
Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy		Month 6
Time for Restoration of Initial Dosing Regimen		Month 6
Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen		Month 6
Number of Participants Who Were Not Adhering to Recommended Management of AEs		Month 6
Percentage of Participants Still on Tocilizumab Monotherapy at Month 6		Month 6
Percentage of Participants With Reason for Choice of Monotherapy at Baseline		Baseline
Tender Joint Count (TJC)	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.	Baseline, Month 3, 6
Swollen Joint Count (SJC)	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.	Baseline, Month 3, 6
Percentage of Participants With Disease Activity Score-28 (DAS28)	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.	Baseline, Month 3, 6
Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 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.	Month 3, 6
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 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.	Month 3, 6
Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response	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.	Baseline, Month 3, 6
Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response	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.	Baseline, Month 3, 6
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 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.	Baseline, Month 3, 6
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 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.	Baseline, Month 3, 6
Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 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.	Baseline, Month 3, 6
Change From Baseline in VAS-Fatigue at Month 3 and Month 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.	Baseline, Month 3, 6
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 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.	Baseline, Month 3, 6
Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 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.	Baseline, Month 3, 6
Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)	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.	Month 6
Percentage of Participants With AEs Leading to Dose Modifications		Month 6
C-reactive Protein (CRP]) Level	CRP is an acute phase reactant and is a measure of inflammation.	Baseline, Month 3, 6
Erythrocyte Sedimentation Rate (ESR) Level	ESR is an acute phase reactant and is a measure of inflammation.	Baseline, Month 3, 6

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2012
• Primary Completion (Actual): December 12, 2014
• Study Completion (Actual): December 12, 2014

Study Registration Dates

• First Submitted: October 10, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (Estimate): October 12, 2012

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML28269