Clinical trial NCT01671059: A Non-Interventional Study Evaluating Rheumatoid Arthritis Participants Treated With Tocilizumab (RoActemra/Actemra)
Official title: A Multi-Center, Non-Interventional Study to Evaluate Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (ACROSS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 80
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 initiated on treatment with tocilizumab (RoActemra/Actemra)

Brief summary: This non-interventional study evaluated the use and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment according to the approved label were followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult participants, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
* Participants in whom the treating physician made the decision to commence tocilizumab treatment (in accordance with the local label); this could include participants who had received tocilizumab treatment within 8 weeks prior to the enrollment visit

Exclusion Criteria:

* Participants who had received tocilizumab more than 8 weeks prior to the enrollment visit
* Participants who had previously received tocilizumab in a clinical trial or for compassionate use
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever was longer) before starting treatment with tocilizumab
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of Participants With Dose Modifications
timeFrame: 6 months
measure: Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
timeFrame: 6 months
measure: Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents
timeFrame: Baseline
measure: Reasons for Dose Modifications
timeFrame: 6 months
measure: Percentage of Participants With Dose Interruptions
timeFrame: 6 months
measure: Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy
timeFrame: 6 months
measure: Percentage of Participants on Tocilizumab Monotherapy at Study Entry
timeFrame: 6 months
measure: Disease Activity Score Based on 28-Joint Count (DAS28)
timeFrame: 6 months
measure: Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category
timeFrame: 6 months
measure: Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category
timeFrame: 6 months
measure: Simplified Disease Activity Index (SDAI)
timeFrame: 6 months
measure: Clinical Disease Activity Index (CDAI) Score
timeFrame: 6 months
measure: Percentage of Participants With American College of Rheumatology (ACR) Response
timeFrame: 6 months
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs)
timeFrame: 6 months
measure: Patient Global Assessment of Disease Activity Score
timeFrame: 6 months
measure: Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: 6 months
measure: Visual Analogue Scale (VAS) for Fatigue
timeFrame: 6 months
measure: Visual Analogue Scale (VAS) for Morning Stiffness
timeFrame: 6 months
measure: Visual Analogue Scale (VAS) for Pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Belgrade
country: Serbia
facility: Institut Za Reumatologiju; Reumatologiju
city: Belgrade
country: Serbia
facility: Military Medical Academy; Clinic of Rheumatology
city: Belgrade
country: Serbia
city: Niska Banja
country: Serbia
facility: Institute of Rheumatology and Cardiovascular Diseases; Rheumatology
city: Niska Banja
country: Serbia
city: Novi Sad
country: Serbia
facility: Clinical Center Voivodina; Clinic for Immunology and Nephrology
city: Novi Sad
country: Serbia
facility: Special hospital for rheumatic diseases Novi Sad
city: Novi Sad
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: