A Non-Interventional Study Evaluating Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01671059
First received: August 20, 2012
Last updated: August 4, 2014
Last verified: August 2014

August 20, 2012
August 4, 2014
July 2012
June 2015   (final data collection date for primary outcome measure)
Proportion of patients on RoActemra/Actemra 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 NCT01671059 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 ]
  • Efficacy: Monotherapy versus combination therapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Use of disease-modifying anti-rheumatic drugs (DMARDs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Non-Interventional Study Evaluating Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)
A Multi-Center, Non-inteRventional Study in rheumatOid Arthritis patientS Treated With Tocilizumab in Serbia- ACROSS; (Part of Global Umbrella Project)

This non-interventional study will evaluate the use and efficacy of RoActemra/Ac temra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. El igible patients initiated on RoActemra/Actemra treatment according to the approv ed 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 (tocilizumab)

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.
 
Recruiting
50
June 2015
June 2015   (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 accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

  • 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
  • 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
Both
18 Years and older
No
Contact: Reference Study ID Number: ML28314 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
Serbia
 
NCT01671059
ML28314
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

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