Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 16, 2012
Last updated: November 3, 2014
Last verified: November 2014

July 16, 2012
November 3, 2014
August 2012
August 2012   (final data collection date for primary outcome measure)
Proportion of patients on RoActemra/Actemra at 6 months [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01643863 on Archive Site
  • Rates of dose modifications/interruptions [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Physician Global Assessment of disease activity [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Patient reported outcomes: Health Assessment Questionnaires [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs) [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Time to reduction/withdrawal of corticosteroids [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events\n [ Time Frame: approximately 20 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (MONACO)
A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (TCZ)

This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible pa tients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Not Provided
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra in monotherapy

Rheumatoid Arthritis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2012
August 2012   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP