Phase 4
Completed N=23
A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)
Source: ClinicalTrials.gov NCT02010216 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Change From Baseline in Disease Activity 28 (DAS28) Score — -3.9 score on a scale
Summary
This open-label, single arm study evaluated the efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Patients received RoActemra/Actemra 8 mg/kg intravenously every 4 weeks, alone or in combination with standard anti-rheumatic therapy, for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity 28 (DAS28) Score |
-3.9 | — |
| PRIMARY Percentage of Participants Achieving ACR20/50/70 Responses After the Third Infusion Categorized by Highest Response Achieved |
0.0; 9.5; 66.7 | — |
| PRIMARY Safety: Number of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) |
5; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, ≥ 18 years of age
- Confirmed moderate or severe rheumatoid arthritis
- Intolerability or absence of effect or decrease in effect of rheumatoid arthritis treatment with disease modifying antirheumatic drugs (DMARDs)
Exclusion Criteria
- Presence of infectious diseases [tuberculosis (Tb), human immunodeficiency virus (HIV), virus hepatitis A/B/C]
- Inadequate hematologic, renal or liver function
- Peptic ulcer disease (in acute phase)
- Pregnant and lactating women
Data sourced from ClinicalTrials.gov (NCT02010216). 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.