N/A
Completed N=80
A Non-Interventional Study Evaluating Rheumatoid Arthritis Participants Treated With Tocilizumab (RoActemra/Actemra)
Source: ClinicalTrials.gov NCT01671059 ↗Enrolled (actual)
80
Serious AEs
13.8%
Results posted
Dec 2016
Primary outcomePrimary: Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation — 93.75 percentage of participants
Summary
This non-interventional study evaluated the use and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment according to the approved label were followed for 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on Tocilizumab 6 Months After Treatment Initiation |
93.75 | — |
| SECONDARY Percentage of Participants With Dose Modifications |
11.2 | — |
| SECONDARY Percentage of Participants Receiving Tocilizumab After Failing Disease-Modifying Anti-Rheumatic Drugs (DMARDs) |
81.35 | — |
| SECONDARY Percentage of Participants Receiving Tocilizumab After Failing Other Biologic Agents |
18.8 | — |
| SECONDARY Reasons for Dose Modifications |
1; 3; 1; 1; 3 | — |
| SECONDARY Percentage of Participants With Dose Interruptions |
3.75 | — |
| SECONDARY Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy |
3; 1 | — |
| SECONDARY Percentage of Participants on Tocilizumab Monotherapy at Study Entry |
13.6 | — |
| SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28) |
2.78; 2.45 | — |
| SECONDARY Percentage of Participants on Combination Therapy Achieving a Response by European League Against Rheumatism (EULAR) Category |
62.3; 32.1; 5.7 | — |
| SECONDARY Percentage of Participants on Monotherapy Achieving a Response by European League Against Rheumatism (EULAR) Category |
71.4; 28.6; 0.0 | — |
| SECONDARY Simplified Disease Activity Index (SDAI) |
6.69; 4.5 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) Score |
7.05; 6 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) Response |
87.8; 100; 46.3; 66.6; 41.4; 33.3 | — |
| SECONDARY Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interest (AESIs) |
25; 13.75; 1.25 | — |
| SECONDARY Patient Global Assessment of Disease Activity Score |
15; 14 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) |
0.43; 0.43 | — |
| SECONDARY Visual Analogue Scale (VAS) for Fatigue |
15; 11 | — |
| SECONDARY Visual Analogue Scale (VAS) for Morning Stiffness |
10; 12 | — |
| SECONDARY Visual Analogue Scale (VAS) for Pain |
20; 20 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
- Participants in whom the treating physician made the decision to commence tocilizumab treatment (in accordance with the local label); this could include participants who had received tocilizumab treatment within 8 weeks prior to the enrollment visit
Exclusion Criteria
- Participants who had received tocilizumab more than 8 weeks prior to the enrollment visit
- Participants who had previously received tocilizumab in a clinical trial or for compassionate use
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever was longer) before starting treatment with tocilizumab
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01671059). 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.