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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01643863
First Posted: July 18, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
July 16, 2012
July 18, 2012
November 2, 2016
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 ]
Same as current
Complete list of historical versions of study NCT01643863 on ClinicalTrials.gov Archive Site
  • Rates of dose modifications/interruptions [ Time Frame: approximately 20 months ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 20 months ]
  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 20 months ]
  • Physician Global Assessment of disease activity [ Time Frame: approximately 20 months ]
  • Patient reported outcomes: Health Assessment Questionnaires [ Time Frame: approximately 20 months ]
  • Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs) [ Time Frame: approximately 20 months ]
  • Time to reduction/withdrawal of corticosteroids [ Time Frame: approximately 20 months ]
  • Safety: Incidence of adverse events\n [ Time Frame: approximately 20 months ]
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 patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.
Not Provided
Observational
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
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Portugal
 
 
NCT01643863
ML28202
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016