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: April 7, 2014
Last verified: April 2014
  Purpose

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


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: RheumaToid arthRitis Patients Treated With tocilizUmab in Real Clinical Practice: effectiveneSs and safeTy

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 322
Study Start Date: April 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394276

  Show 57 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01394276     History of Changes
Other Study ID Numbers: ML25728
Study First Received: July 13, 2011
Last Updated: April 7, 2014
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014