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 (TRUST Study)
1 other identifier
observational
322
1 country
56
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2011
56 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 13, 2011
CompletedFirst Posted
Study publicly available on registry
July 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedResults Posted
Study results publicly available
June 7, 2016
CompletedSeptember 11, 2025
August 1, 2025
1.9 years
July 13, 2011
April 30, 2016
August 22, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
Low disease activity is defined as a disease activity score based on 28 joint count (DAS28) score lesser or equal to (\</=) 3.2. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. Erythrocyte sedimentation rate (ESR) or C reactive protein (CRP) measurement, 4. Participant's judgement on his own overall health status expressed by a visual analogue scale (VAS). The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. Percentage of participants with low disease activity was reported.
Up to 12 months
Percentage of Participants Achieving Disease Remission After 6 Months of Treatment
Disease remission is defined as a DAS28 score \< 2.6. The DAS28 is an evaluation index of RA. DAS28 applies a mathematical formula based on the following parameters: 1. Tender joints count (28 joints), 2. Swollen joints count (28 joints), 3. ESR or CRP measurement, 4. Participant's judgment on his own overall health status expressed by a VAS and calculates total score of 0 to approximately 10. The DAS28 scale ranges from 0 to 10, where scores below 2.6 indicate best disease control, scores above 5.1 indicate worse disease control, higher scores represent higher disease activity and negative change from baseline score indicates improvement. The response to therapy is defined according to the disease activity detected, compared to the previous clinical evaluation. Percentage of participants with disease remission was reported.
Up to 12 months
Secondary Outcomes (14)
Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab
Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12
Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab
Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Number of Participants With Concomitant Medications
Up to 12 months
Percentage of Participants Discontinuing Treatment With Tocilizumab
Up to 12 months
- +9 more secondary outcomes
Study Arms (1)
Tocilizumab
Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra \[Tocilizumab (TCZ)\] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).
Eligibility Criteria
Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra
You may qualify if:
- 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
You may not qualify if:
- Current serious infection
- Hypersensitivity to the active component or any of the excipients
- Pregnant women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (56)
Unknown Facility
Coppito, Abruzzo, 67100, Italy
Unknown Facility
Pescara, Abruzzo, 65100, Italy
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Brindisi, Apulia, 72100, Italy
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Casarano (LE), Apulia, 73042, Italy
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Foggia, Apulia, 71100, Italy
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Martina Franca, Apulia, 74015, Italy
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San Cesario di Lecce, Apulia, 73016, Italy
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Reggio Calabria, Calabria, 89133, Italy
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Avellino, Campania, 83100, Italy
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Gragnano, Campania, 80054, Italy
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Napoli, Campania, 80131, Italy
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Napoli, Campania, 80138, Italy
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Napoli, Campania, 80144, Italy
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Salerno, Campania, 84131, Italy
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Telese Terme, Campania, 82037, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Ferrara, Emilia-Romagna, 44100, Italy
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Modena, Emilia-Romagna, 41100, Italy
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Piacenza, Emilia-Romagna, 29100, Italy
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Trieste, Friuli Venezia Giulia, 34142, Italy
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Albano Laziale, Lazio, 00041, Italy
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Rome, Lazio, 00128, Italy
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Rome, Lazio, 00145, Italy
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Rome, Lazio, 00152, Italy
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Rome, Lazio, 00168, Italy
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Rome, Lazio, 00189, Italy
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Viterbo, Lazio, 01100, Italy
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Arenzano, Liguria, 16011, Italy
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Castel Goffredo, Lombardy, 46042, Italy
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Gavardo, Lombardy, 25085, Italy
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Legnano, Lombardy, 20025, Italy
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Milan, Lombardy, 20157, Italy
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Monza, Lombardy, 20052, Italy
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Pavia, Lombardy, 27100, Italy
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Rozzano, Lombardy, 20089, Italy
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Saronno, Lombardy, 21047, Italy
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Treviglio, Lombardy, 24047, Italy
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Vimercate, Lombardy, 20059, Italy
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Agnone, Molise, 86081, Italy
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Cuneo, Piedmont, 12100, Italy
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Novara, Piedmont, 28100, Italy
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Turin, Piedmont, 10126, Italy
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Sassari, Sardinia, 07100, Italy
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Catania, Sicily, 95124, Italy
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Gazzi, Sicily, 98125, Italy
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Palermo, Sicily, 90127, Italy
Unknown Facility
Palermo, Sicily, 90146, Italy
Unknown Facility
Ancona, The Marches, 60020, Italy
Unknown Facility
Iesi, The Marches, 60035, Italy
Unknown Facility
Florence, Tuscany, 50139, Italy
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Massa, Tuscany, 54100, Italy
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Pisa, Tuscany, 56100, Italy
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Prato, Tuscany, 59100, Italy
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Perugia, Umbria, 06122, Italy
Unknown Facility
Verona, Veneto, 37126, Italy
Unknown Facility
Verona, Veneto, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Roche Trial Information Hotline
- Organization
- F. Hoffmann-La Roche AG
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 13, 2011
First Posted
July 14, 2011
Study Start
May 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
September 11, 2025
Results First Posted
June 7, 2016
Record last verified: 2025-08