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: October 13, 2014
Last verified: October 2014
  Purpose

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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
Italy
Coppito, Abruzzo, Italy, 67100
Pescara, Abruzzo, Italy, 65100
Reggio Calabria, Calabria, Italy, 89133
Avellino, Campania, Italy, 83100
Gragnano, Campania, Italy, 80054
Napoli, Campania, Italy, 80131
Napoli, Campania, Italy, 80144
Napoli, Campania, Italy, 80138
Salerno, Campania, Italy, 84131
Telese Terme, Campania, Italy, 82037
Bologna, Emilia-Romagna, Italy, 40138
Ferrara, Emilia-Romagna, Italy, 44100
Modena, Emilia-Romagna, Italy, 41100
Piacenza, Emilia-Romagna, Italy, 29100
Trieste, Friuli-Venezia Giulia, Italy, 34142
Albano Laziale, Lazio, Italy, 00041
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00189
Roma, Lazio, Italy, 00145
Roma, Lazio, Italy, 00128
Roma, Lazio, Italy, 00152
Viterbo, Lazio, Italy, 01100
Arenzano, Liguria, Italy, 16011
Castel Goffredo, Lombardia, Italy, 46042
Gavardo, Lombardia, Italy, 25085
Legnano, Lombardia, Italy, 20025
Milano, Lombardia, Italy, 20157
Monza, Lombardia, Italy, 20052
Pavia, Lombardia, Italy, 27100
Rozzano, Lombardia, Italy, 20089
Saronno, Lombardia, Italy, 21047
Treviglio, Lombardia, Italy, 24047
Vimercate, Lombardia, Italy, 20059
Ancona, Marche, Italy, 60020
Jesi, Marche, Italy, 60035
Agnone, Molise, Italy, 86081
Cuneo, Piemonte, Italy, 12100
Novara, Piemonte, Italy, 28100
Torino, Piemonte, Italy, 10126
Brindisi, Puglia, Italy, 72100
Casarano (LE), Puglia, Italy, 73042
Foggia, Puglia, Italy, 71100
Martina Franca, Puglia, Italy, 74015
San Cesario Di Lecce, Puglia, Italy, 73016
Sassari, Sardegna, Italy, 07100
Catania, Sicilia, Italy, 95124
Gazzi, Sicilia, Italy, 98125
Palermo, Sicilia, Italy, 90146
Palermo, Sicilia, Italy, 90127
Firenze, Toscana, Italy, 50139
Massa, Toscana, Italy, 54100
Pisa, Toscana, Italy, 56100
Prato, Toscana, Italy, 59100
Perugia, Umbria, Italy, 06122
Verona, Veneto, Italy, 37126
Verona, Veneto, Italy, 37134
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: October 13, 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 October 19, 2014