N/A
Completed N=322
An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)
Source: ClinicalTrials.gov NCT01394276 ↗Enrolled (actual)
322
Serious AEs
8.7%
Results posted
Jun 2016
Primary outcomePrimary: Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment — 57.52 percentage of participants — p=0.0237
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment |
57.52 | 0.0237 sig |
| PRIMARY Percentage of Participants Achieving Disease Remission After 6 Months of Treatment |
38.05 | 0.0003 sig |
| SECONDARY Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab |
5.4; 3.6; 3.3; 3.2; 3.0; 2.8 | — |
| SECONDARY Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab |
62.8; 48.2; 41.8; 38.8; 38.8; 33.1 | — |
| SECONDARY Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab |
1.6; 1.2; 1.1; 1.0; 1.1; 1.1 | — |
| SECONDARY Number of Participants With Concomitant Medications |
142; 130 | — |
| SECONDARY Percentage of Participants Discontinuing Treatment With Tocilizumab |
19.2 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
214; 28 | — |
| SECONDARY Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion |
80.8 | — |
| SECONDARY Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand. |
25; 7; 16; 5; 1; 1 | — |
| SECONDARY Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand. |
26; 9; 12; 6; 2; 1 | — |
| SECONDARY Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand |
24; 9; 16; 3; 1; 1 | — |
| SECONDARY Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand. |
25; 9; 14; 5; 1; 1 | — |
| SECONDARY Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents |
5.3; 5.3; 3.6; 3.7; 3.1; 3.4 | 0.8080 |
| SECONDARY Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents |
62.3; 58.7; 50.1; 48.0; 50.6; 44.1 | 0.4211 |
| SECONDARY Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents |
1.5; 1.5; 1.1; 1.3; 1.2; 1.2 | 0.7343 |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01394276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.