N/A
Completed N=16
An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01741688 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Oct 2015
Primary outcomePrimary: Number of Participants on Tocilizumab at 6 Months After Treatment Initiation — 14 participants
Summary
This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were followed for 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants on Tocilizumab at 6 Months After Treatment Initiation |
14 | — |
| SECONDARY Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis |
93.8 | — |
| SECONDARY Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure |
18.8; 62.5 | — |
| SECONDARY Number of Participants Starting Tocilizumab After Failing Other Biologic Agents |
1 | — |
| SECONDARY Median Dose at 6 Months |
8 | — |
| SECONDARY Number of Participants With Dose Modifications at 6 Months |
4 | — |
| SECONDARY Median Duration of Treatment |
6 | — |
| SECONDARY Percentage of Participants Discontinued From Tocilizumab for Safety |
— | — |
| SECONDARY Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy |
— | — |
| SECONDARY Number of Participants Discontinued From Tocilizumab for Other Reasons |
3 | — |
| SECONDARY Time to Restoration of Initial Dosing Regimen |
— | — |
| SECONDARY Non-adherence Rate of Physician to the Recommended Dosing Regimen |
— | — |
| SECONDARY Percentage of Participants on Tocilizumab Monotherapy at Study Entry |
12.5 | — |
| SECONDARY Total Tender Joint Count (TJC) |
18; 0; 0; 0; 0; 0 | — |
| SECONDARY Total Swollen Joint Count (SJC) |
18; 0.5; 0; 0; 0; 0 | — |
| SECONDARY Disease Activity Score Based on 28 Joints (DAS28) |
6.29; 2.87; 2.23; 2.16; 2.45; 2.41 | — |
Eligibility Criteria
Inclusion Criteria
- Adults, >/= 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 has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit
Exclusion Criteria
- Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit
- Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01741688). 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.