Phase 3
Completed N=14
A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs
Source: ClinicalTrials.gov NCT00810277 ↗Enrolled (actual)
14
Serious AEs
7.1%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) — 92.9; 7.1 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) |
92.9; 7.1 | — |
| SECONDARY Disease Activity Score (DAS28) |
5.9896986; 2.852859; 2.1529895; 1.9199257; 1.6475303; 1.6527143 | — |
| SECONDARY Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6) |
42.86; 69.23; 83.33; 76.92; 84.62; 69.23 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response |
57.14; 100.00; 76.92; 100.00; 84.62; 100.00 | — |
| SECONDARY C-Reactive Protein (CRP) Level |
35.81; 1.29; 1.43; 1.16; 2.42; 1.10 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
37.14; 3.71; 4.85; 2.42; 3.00; 2.46 | — |
| SECONDARY Percentage of Participants Who Discontinued the Study |
7.1 | — |
| SECONDARY Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal |
7.14; 7.69 | — |
| SECONDARY Percentage of Participants With Lipid Level Elevations |
15.38; 30.77; 38.46; 15.38; 0.00; 30.77 | — |
| SECONDARY Neutrophil Count |
5.53; 2.31; 2.32; 2.12 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- moderate to severe rheumatoid arthritis;
- inadequate response to current non-biologic DMARDs
Exclusion Criteria
- rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
- previous treatment with other biologics.
Data sourced from ClinicalTrials.gov (NCT00810277). 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.