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An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01669902
First received: August 13, 2012
Last updated: November 3, 2014
Last verified: November 2014

August 13, 2012
November 3, 2014
April 2012
September 2014   (final data collection date for primary outcome measure)
Proportion of patients on RoActemra/Actemra treatment at 6 months after treatment initiation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01669902 on ClinicalTrials.gov Archive Site
  • Rates of dose modifications/interruptions [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Clinical/demographic patient characteristics at initiation of treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Patient recorded outcomes: Health Assessment Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Introduction/use of disease-modifying anti-rheumatic drugs (DMARDs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
HAQIMONO a Non-interventional National Multicenter Study, Observing RA Patients Treated With Tocilizumab in Mono-therapy, i.e. Without Combination With DMARD

This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumato id arthritis unable to use methotrexate. Eligible patients initiated on RoActemr

a/Actemra treatment will be followed for 6 months.

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

Patients with active moderate to severe rheumatoid arthritis unable to use methotrexate

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.
 
Completed
107
September 2014
September 2014   (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 who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included
  • Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed

Exclusion Criteria:

  • Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment
  • History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Norway,   Sweden
 
NCT01669902
ML28247
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