Phase 2
Completed N=76
A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00887341 ↗
Enrolled (actual)
76
Serious AEs
5.3%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion — 29.7; 17.9 percentage of participants — p=0.238
Summary
This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion |
29.7; 17.9 | 0.238 |
| SECONDARY Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE) |
2.7; 0.0 | — |
| SECONDARY Percentage of Participants Discontinuing Tocilizumab for Any Reason |
2.7; 2.6 | — |
| SECONDARY Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit |
56.7; 61.9; 58.6; 74.1; 77.8; 92.3 | — |
| SECONDARY Percentage of Participants Achieving a DAS28 Score <3.2 by Visit |
22.2; 32.0; 25.0; 60.0; 46.9; 77.1 | — |
| SECONDARY Percentage of Participants Achieving a DAS28 Score <2.6 (Remission) |
11.1; 20.0; 18.8; 34.3; 34.4; 57.1 | — |
| SECONDARY DAS28 Score by Visit |
5.75; 5.32; 4.28; 3.62; 4.14; 3.05 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) |
26.5; 48.5; 51.5; 59.4; 60.0; 69.7 | 0.121 |
| SECONDARY Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) |
11.4; 20.6; 26.5; 39.4; 35.5; 47.1 | 0.377 |
| SECONDARY Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) |
0.0; 2.9; 12.1; 14.7; 22.6; 28.6 | 0.327 |
| SECONDARY Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) |
0.0; 0.0; 2.9; 2.9; 3.1; 5.7 | 0.970 |
| SECONDARY C-Reactive Protein (CRP) Levels |
9.28; 10.76; 11.49; 13.68; 6.45; 4.29 | — |
| SECONDARY Erythrocyte Sedimentation Rate |
37.70; 31.19; 42.53; 30.40; 15.03; 11.41 | — |
| SECONDARY HAQ-DI Score by Visit |
1.6; 1.4; 1.4; 1.0; 1.3; 0.9 | — |
| SECONDARY Percentage of Participants With Improvement of at Least 0.22 in HAQ-DI |
48.6; 48.6; 62.9; 54.3; 64.5; 58.8 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- active moderate or severe rheumatoid arthritis;
- active disease for >6 months;
- inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.
Exclusion Criteria
- rheumatic autoimmune disease other than rheumatoid arthritis;
- prior history of, or current inflammatory joint disease other than rheumatoid arthritis;
- major surgery (including joint surgery) within 8 weeks prior to screening, or planned major surgery within 6 months following enrollment.
Data sourced from ClinicalTrials.gov (NCT00887341). 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.