Clinical trial NCT01705730: A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy
Official title: Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-10-12
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in monotherapy

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.


Eligibility 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

Primary outcomes:
measure: Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation
timeFrame: Month 6 after treatment initiation
Secondary outcomes:
measure: Percentage of Participants With Systemic Manifestations of RA at Baseline
timeFrame: Baseline
measure: Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response
timeFrame: Baseline
measure: Number of Participants With Inadequate Response to Other Biologics
timeFrame: Baseline
measure: Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)
timeFrame: Month 6
measure: Percentage of Participants Who Had DMARDs During Study
timeFrame: Month 6
measure: Number of Participants With Dose Reductions
timeFrame: 6 months
measure: Number of Participants With Starting Tocilizumab After Failing DMARDs
timeFrame: Baseline
measure: Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents
timeFrame: Baseline
measure: Time to Reduction/Withdrawal of Corticosteroids
timeFrame: Month 6
measure: Number of Dose Modifications Per Participant at Month 6
timeFrame: Month 6
measure: Mean Dosing Interval Per Participant at Month 6
timeFrame: Month 6
measure: Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
timeFrame: Month 6
measure: Time for Restoration of Initial Dosing Regimen
timeFrame: Month 6
measure: Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen
timeFrame: Month 6
measure: Number of Participants Who Were Not Adhering to Recommended Management of AEs
timeFrame: Month 6
measure: Percentage of Participants Still on Tocilizumab Monotherapy at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Reason for Choice of Monotherapy at Baseline
timeFrame: Baseline
measure: Tender Joint Count (TJC)
timeFrame: Baseline, Month 3, 6
measure: Swollen Joint Count (SJC)
timeFrame: Baseline, Month 3, 6
measure: Percentage of Participants With Disease Activity Score-28 (DAS28)
timeFrame: Baseline, Month 3, 6
measure: Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6
timeFrame: Month 3, 6
measure: Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6
timeFrame: Month 3, 6
measure: Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response
timeFrame: Baseline, Month 3, 6
measure: Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response
timeFrame: Baseline, Month 3, 6
measure: Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6
timeFrame: Baseline, Month 3, 6
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6
timeFrame: Baseline, Month 3, 6
measure: Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6
timeFrame: Baseline, Month 3, 6
measure: Change From Baseline in VAS-Fatigue at Month 3 and Month 6
timeFrame: Baseline, Month 3, 6
measure: Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6
timeFrame: Baseline, Month 3, 6
measure: Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6
timeFrame: Baseline, Month 3, 6
measure: Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs)
timeFrame: Month 6
measure: Percentage of Participants With AEs Leading to Dose Modifications
timeFrame: Month 6
measure: C-reactive Protein (CRP]) Level
timeFrame: Baseline, Month 3, 6
measure: Erythrocyte Sedimentation Rate (ESR) Level
timeFrame: Baseline, Month 3, 6
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: ASZ Aalst
city: Ath
country: Belgium
facility: CH EpiCURA Site Ath
city: Bruxelles
country: Belgium
facility: CHU Brugmann (Victor Horta)
city: Bruxelles
country: Belgium
facility: Hospital Erasme; Neurologie
city: Genk
country: Belgium
facility: Reumaclinic
city: Gilly (Charleroi)
country: Belgium
facility: GHdC Site Saint-Joseph
city: Gosselies
country: Belgium
facility: Clinique Notre Dame de Grâce
city: Haine-Saint-Paul
country: Belgium
facility: CH Jolimont - Lobbes (Jolimont)
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Liège
country: Belgium
facility: Chr de La Citadelle
city: Liège
country: Belgium
facility: Clinique Saint-Joseph
city: Mons
country: Belgium
facility: CHU Ambroise Paré
city: Oostende
country: Belgium
facility: AZ Damiaan
city: Ottignies
country: Belgium
facility: Clinique St Pierre asbl
city: Roeselare
country: Belgium
facility: AZ Delta (Campus Wilgenstraat)
city: Turnhout
country: Belgium
facility: AZ Turnhout Sint Jozef
city: Wilrijk
country: Belgium
facility: Sint Augustinus Wilrijk
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: