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

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.
 
ClinicalTrials.gov Identifier: NCT01565122
Recruitment Status : Completed
First Posted : March 28, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date March 26, 2012
First Posted Date March 28, 2012
Last Update Posted Date November 2, 2016
Study Start Date March 2012
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 26, 2012)
Proportion of patients on RoActemra/Actemra treatment at 6 months [ Time Frame: approximately 2.5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 26, 2012)
  • Rates of dose modifications/interruptions [ Time Frame: approximately 2.5 years ]
  • Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment [ Time Frame: approximately 2.5 years ]
  • Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR [ Time Frame: approximately 2.5 years ]
  • Efficacy: Monotherapy versus combination therapy [ Time Frame: approximately 2.5 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ]
  • Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales [ Time Frame: approximately 2.5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)
Official Title An Observational, Non-interventional, Multi-national Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Brief Summary This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Rheumatoid arthritis patients initiated on RoActemra/Actemra treatment
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Cohort
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 27, 2014)
51
Original Estimated Enrollment
 (submitted: March 26, 2012)
70
Actual Study Completion Date May 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis
  • Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

Exclusion Criteria:

  • RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
  • Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Finland
Removed Location Countries  
 
Administrative Information
NCT Number NCT01565122
Other Study ID Numbers ML28207
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016