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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01394276
First received: July 13, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  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:

Drug Information available for: Tocilizumab
U.S. FDA Resources

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
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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

  Hide Study Locations
Locations
Italy
Agnone, Italy, 86081
Albano Laziale, Italy, 00041
Ancona, Italy, 60020
Arenzano, Italy, 16011
Avellino, Italy, 83100
Bologna, Italy, 40136
Bologna, Italy, 40138
Brindisi, Italy, 72100
Casarano (le), Italy, 73042
Castel Goffredo, Italy, 46042
Catania, Italy, 95124
Coppito, Italy, 67100
Cuneo, Italy, 12100
Ferrara, Italy, 44100
Firenze, Italy, 50139
Foggia, Italy, 71100
Foggia, Italy, 71122
Gavardo, Italy, 25085
Gazzi, Italy, 98125
Gragnano, Italy, 80054
Jesi, Italy, 60035
Legnano, Italy, 20025
Martina Franca, Italy, 74015
Massa, Italy, 54100
Milano, Italy, 20157
Modena, Italy, 41100
Monza, Italy, 20052
Napoli, Italy, 80131
Napoli, Italy, 80138
Napoli, Italy, 80144
Novara, Italy, 28100
Palermo, Italy, 90146
Palermo, Italy, 90127
Pavia, Italy, 27100
Perugia, Italy, 06122
Pescara, Italy, 65100
Piacenza, Italy, 29100
Pisa, Italy, 56100
Prato, Italy, 59100
Reggio Calabria, Italy, 89133
Rieti, Italy, 02100
Roma, Italy, 00189
Roma, Italy, 00168
Roma, Italy, 00152
Roma, Italy, 00145
Roma, Italy, 00128
Rozzano, Italy, 20089
Salerno, Italy, 84131
San Cesario Di Lecce, Italy, 73016
Saronno, Italy, 21047
Sassari, Italy, 07100
Telese Terme, Italy, 82037
Torino, Italy, 10126
Treviglio, Italy, 24047
Trieste, Italy, 34142
Verona, Italy, 37126
Verona, Italy, 37134
Vimercate, Italy, 20871
Viterbo, Italy, 01100
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: May 7, 2013
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 May 19, 2013