Clinical trial NCT01893255: A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)
Official title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Who Are Treated With Tocilizumab
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-07-08
Enrollment: 0
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 in monotherapy

Brief summary: This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 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 weeks prior to the enrolment visit
* Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
* Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
* Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed

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
* Patients receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
* Patients 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
* Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation
timeFrame: Month 6
Secondary outcomes:
measure: Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
timeFrame: approximately 6 months
measure: Rates of dose modifications/interruptions
timeFrame: approximately 6 months
measure: Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
timeFrame: approximately 6 months
measure: Physician's Global Assessment of Disease Activity
timeFrame: approximately 6 months
measure: Safety: Incidence of adverse events
timeFrame: approximately 6 months
measure: Patient reported outcomes (Patient Global Assessment of disease activity, HAQ-DI, VAS-Fatigue, severity of pain and morning stiffness)
timeFrame: approximately 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: