An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01394276
First received: July 13, 2011
Last updated: July 7, 2014
Last verified: July 2014

July 13, 2011
July 7, 2014
April 2011
April 2013   (final data collection date for primary outcome measure)
  • Percentage of patients achieving disease activity score DAS28 </= 3.2 after 6 months of treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Percentage of patients achieving remission (DAS28 < 2.6) after 6 months of treatment [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01394276 on ClinicalTrials.gov Archive Site
  • Disease activity score (DAS28) in patients on monotherapy with RoActemra/Actemra [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Comparison of disease activity score (DAS28) in patients with inadequate response to DMARDs and anti-TNF drugs [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Effect on fatigue: visual analogue scale VAS Fatigue [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Concomitant medications use (particularly corticosteroids) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Percentage of patients discontinuing treatment with RoActemra/Actemra [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Percentage of patients still on RoActemra/Actemra treatment 12 months after the 1st infusion [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
  • Effect on synovitis: ultrasonography of hand [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)
RheumaToid arthRitis Patients Treated With tocilizUmab in Real Clinical Practice: effectiveneSs and safeTy

This observational study will evaluate the efficacy and safety of RoActemra/Acte mra (tocilizumab) in clinical practice in patients with moderate to severe rheum atoid arthritis. Data will be collected from patients for the 12 months followin g the first infusion of RoActemra/Actemra.

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

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
322
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria
  • Initiated on RoActemra/Actemra treatment according to the Summary of Product Characteristics not more than 6 months before opening of study center

Exclusion Criteria:

  • Current serious infection
  • Hypersensitivity to the active component or any of the excipients
  • Pregnant women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01394276
ML25728
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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