N/A
Completed N=43
A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01670045 ↗Enrolled (actual)
43
Serious AEs
32.6%
Results posted
May 2016
Primary outcomePrimary: Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation — 63 percentage of participants
Summary
This multi-center observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation |
63 | — |
| SECONDARY Percentage of Participants With RA Diagnosis |
39.5; 55.8; 4.6 | — |
| SECONDARY Percentage of Participants With Different Body Mass Index (BMI) |
25.6; 39.5; 14; 20.9 | — |
| SECONDARY Percentage of Participants With Rheumatoid Factor Status |
41.9; 58.1 | — |
| SECONDARY Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status |
81.4; 11.6; 7 | — |
| SECONDARY Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline |
6.8; 12.5; 25.6; 41.7; 55.9; 63 | — |
| SECONDARY Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria |
23; 16; 4 | — |
| SECONDARY Number of Participants With Different Types of Simplified Disease Activity Index (SDAI) |
1; 19; 10; 4; 9 | — |
| SECONDARY Number of Participants With Different Types of Clinical Disease Activity Index (CDAI) |
1; 19; 11; 3; 9 | — |
| SECONDARY Percentage of Participants Achieving a Response According to ACR Criteria |
16.7; 48.7; 65.8; 75.0; 84.8; 84.6 | — |
| SECONDARY Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids |
16; 1; 1; 1 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 |
-29; NA | — |
| SECONDARY Percentage of Participants With Tocilizumab Dose Modifications |
33 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or need of RoActemra/Actemra monotherapy); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
Exclusion Criteria
- Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- Patients who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01670045). 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.