Clinical trial NCT01643863: A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (MONACO)
Official title: A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (TCZ)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-18
Enrollment: 1
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 multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed 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 monotherapy, in case of methotrexate intolerance or when continuous methotrexate treatment is inadequate (in accordance with the local label), and who have received (or started) RoActemra/Actemra monotherapy treatment within 8 weeks prior to the enrolment visit.
* Concomitant corticosteroids (oral or intra-articular) or non-steroidal anti-inflammatory drugs (NSAIDs) are allowed

Exclusion Criteria:

* Patients in whom RoActemra/Actemra is contraindicated according to the approved Summary of Product Characteristics
* 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
* Concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting treatment with RoActemra/Actemra
* 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: Proportion of patients on RoActemra/Actemra at 6 months
timeFrame: approximately 20 months
Secondary outcomes:
measure: Rates of dose modifications/interruptions
timeFrame: approximately 20 months
measure: Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
timeFrame: approximately 20 months
measure: Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
timeFrame: approximately 20 months
measure: Physician Global Assessment of disease activity
timeFrame: approximately 20 months
measure: Patient reported outcomes: Health Assessment Questionnaires
timeFrame: approximately 20 months
measure: Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs)
timeFrame: approximately 20 months
measure: Time to reduction/withdrawal of corticosteroids
timeFrame: approximately 20 months
measure: Safety: Incidence of adverse events\n
timeFrame: approximately 20 months
Other outcomes:
Locations:
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: