A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (MONACO)

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (TCZ)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01643863
• Other study ID #: ML28202
• Status: Terminated
• Phase: N/A
• First received: July 16, 2012
• Last updated: November 1, 2016
• Start date: August 2012
• Est. completion date: August 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: National Data Protection Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients on RoActemra/Actemra at 6 months		approximately 20 months	No
Secondary	Rates of dose modifications/interruptions		approximately 20 months	No
Secondary	Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment		approximately 20 months	No
Secondary	Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR		approximately 20 months	No
Secondary	Physician Global Assessment of disease activity		approximately 20 months	No
Secondary	Patient reported outcomes: Health Assessment Questionnaires		approximately 20 months	No
Secondary	Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs)		approximately 20 months	No
Secondary	Time to reduction/withdrawal of corticosteroids		approximately 20 months	No
Secondary	Safety: Incidence of adverse events\n		approximately 20 months	No