Phase 3
Completed N=1,262
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01194414 ↗Enrolled (actual)
1,262
Serious AEs
13.0%
Results posted
Feb 2013
Primary outcomePrimary: Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24 — 69.4; 73.4 Percentage of participants
Summary
This randomized, double-blind, parallel group study compares the efficacy and safety of subcutaneous (sc) versus intravenous (iv) administration of tocilizumab in participants with moderate to severe active rheumatoid arthritis. Participants were randomized to receive either tocilizumab 162 mg sc weekly plus iv placebo every 4 weeks, or tocilizumab 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind period from baseline to Week 24. The double-blind period was followed by a 72-week open-label treatment with some switching of sc and iv administration. No placebo was administered in the open-label phase. Participants continued on their stable dose of disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on study treatment was 2 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR20) Response at Week 24 |
69.4; 73.4 | — |
| PRIMARY Percentage of Participants With Adverse Events, Serious Adverse Events and Clinically Significant Laboratory Assessments |
91.6; 87.8; 81.3; 86.6; 13.9; 12.7 | — |
| SECONDARY Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR50) Response at Week 24 |
47.0; 48.6 | — |
| SECONDARY Percentage of Participants Achieving an American College of Rheumatology Criteria (ACR70) Response at Week 24 |
24.0; 27.9 | — |
| SECONDARY Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 24 |
38.4; 36.9 | — |
| SECONDARY Percentage of Participants Achieving a Decrease of ≥ 0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 24 |
65.2; 67.4 | — |
| SECONDARY Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 24 |
1.8; 0.9 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology Criteria (ACR20, ACR50, ACR70) at Week 97 |
83.6; 83.3; 82.5; 88.5; 65.4; 62.5 | — |
| SECONDARY Percentage of Participants With Disease Activity Score 28 (DAS28) Remission at Week 97 |
53.4; 46.4; 50.0; 55.6 | — |
| SECONDARY Percentage of Participants Achieving a Decrease of ≥0.3 in the Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline to Week 97 |
72.4; 69.1; 56.4; 71.0 | — |
| SECONDARY Percentage of Participants Who Withdrew Because of Lack of Therapeutic Response at Week 97 |
1.7; 3.0; 4.2; 1.6 | — |
| SECONDARY Area Under the Serum Concentration Curve of Tocilizumab After First SC Injection or IV Infusion |
1444; 30988 | — |
| SECONDARY Area Under the Serum Concentration Curve of Tocilizumab at Steady State for SC and IV Treatment |
7542; 41304 | — |
| SECONDARY Minimum Serum Concentration (Cmin) of Tocilizumab |
7.48; 6.65; 35.7; 16.0 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Tocilizumab |
14.7; 180; 52.7; 233 | — |
| SECONDARY Time to Maximum Serum Concentration (Tmax) of Tocilizumab |
74; 6; 70; 6 | — |
| SECONDARY Change From Baseline in Serum Interleukin-6 (IL-6) Concentration at Week 25 |
39.04; 52.48; 62.18; 50.07; 34.42; 52.61 | — |
| SECONDARY Change From Baseline in Serum Soluble Interleukin-6 Receptor (sIL-6R) Concentration at Week 97 |
44.53; 45.72; 44.71; 43.28; 601.52; 575.75 | — |
| SECONDARY Percentage of Participants Who Developed Antibodies To Tocilizumab at Week 97 |
1.3; 1.0; 0.0; 0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, ≥ 18 years of age
- Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
- Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
- Inadequate response to current DMARD therapy
- Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
- Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline
Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
- Rheumatic autoimmune disease other than RA
- Functional class IV (ACR classification)
- Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
- Prior history of or current inflammatory joint disease other than RA
- Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
- Previous treatment with tocilizumab
- Active current or history of recurrent infection
Data sourced from ClinicalTrials.gov (NCT01194414). 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.