Clinical trial NCT01663506: A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)
Official title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-13
Enrollment: 23
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: Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra (tocilizumab)

Brief summary: This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed for 12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 week prior to the enrolment visit

Exclusion Criteria:

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra 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 is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation
timeFrame: 6 Months
Secondary outcomes:
measure: Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation
timeFrame: Month 12
measure: Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity
timeFrame: Up to Month 12
measure: Number of Participants With Comorbidities at Baseline
timeFrame: Baseline
measure: Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs)
timeFrame: Baseline
measure: Number of Participants With Prior Exposure of Biologics
timeFrame: Baseline
measure: Disease Activity Score Based on 28-joints Count (DAS28)
timeFrame: Baseline, Month 3, 6, and 12
measure: Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28
timeFrame: Month 3, 6, and 12
measure: Physician Global Assessment (PGA) of Disease Activity
timeFrame: Baseline, Month 6, and 12
measure: Patient Global Assessment (PtGA) of Disease Activity Score
timeFrame: Baseline, Month 6, and 12
measure: Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
timeFrame: Baseline, Month 6, and 12
measure: Visual Analog Scale (VAS)-Pain
timeFrame: Baseline, Month 6, and 12
measure: Visual Analog Fatigue Scale (VAFS)
timeFrame: Baseline, Month 6, and 12
measure: Visual Analog Scale-Morning Stiffness (VAS-MS)
timeFrame: Baseline, Month 6, and 12
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline, Month 6, and 12
measure: C-Reactive Protein (CRP)
timeFrame: Baseline, Month 6, and 12
measure: Number of Swollen and Tender Joints Based on 66 and 68 Joints
timeFrame: Baseline, Month 6, and 12
measure: Number of Swollen and Tender Joints Based on 28 Joints
timeFrame: Baseline, Month 6, and 12
measure: Simplified Disease Activity Index (SDAI) Score
timeFrame: Baseline, Month 6, and 12
measure: Clinical Disease Activity Index (CDAI) Score
timeFrame: Baseline, Month 6, and 12
measure: Number of Participants Who Received Tocilizumab as Monotherapy
timeFrame: Baseline, Study end (at Month 12 or at time of study discontinuation)
measure: Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs)
timeFrame: Baseline, Study end (at Month 12 or at time of study discontinuation)
measure: Number of Participants Receiving Oral Corticosteroids
timeFrame: Baseline, Month 3, 6, and 12
measure: Number of Participants With Disease Activity Status Based on DAS28 Score
timeFrame: Baseline, Month 3, 6, and 12
measure: Number of Participants With Disease Activity Status Based on SDAI Score
timeFrame: Baseline, Month 3, 6, and 12
measure: Number of Participants With Disease Activity Status Based on CDAI Score
timeFrame: Baseline, Month 3, 6, and 12
Other outcomes:
Locations:
city: Tallinn
country: Estonia
city: Tallinn
country: Estonia
city: Tartu
country: Estonia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: