Phase 2
Completed N=47
A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment
Source: ClinicalTrials.gov NCT01468077 ↗Enrolled (actual)
47
Serious AEs
4.3%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants With Any Infusion Reaction — 13.6; 12.0 Percentage of Participants
Summary
This multi-center, randomized, parallel-group, active-controlled, open-label study will evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion time compared to the normal infusion time. Patients will be randomized to 8 mg/kg RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Any Infusion Reaction |
13.6; 12.0 | — |
| SECONDARY Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE) |
9.0; 8.0 | — |
| SECONDARY Percentage of Participants Discontinuing Tocilizumab for Other Reasons |
9; 4 | — |
| SECONDARY Percentage of Participants With Increased Liver Enzyme Values of Greater Than (>)1.5 Times, or >3 Times, or >5 Times Over the Upper Limit of Normal (ULN) by Visit Among Participants Who Completed All Visits |
12; 5; 6; 10; 6; 5 | — |
| SECONDARY Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits |
44; 46; 44; 55; 50; 36 | — |
| SECONDARY Percentage of Participants With a Reduction of at Least 1.2 Points in Disease Activity Score Based on 28-Joint Count (DAS28) by Visit Among Participants Who Completed All Visits |
67; 55; 89; 73; 89; 82 | — |
| SECONDARY Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits |
44; 27; 67; 55; 78; 82 | — |
| SECONDARY Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits |
22; 9; 28; 36; 50; 73 | — |
| SECONDARY DAS28 Score by Visit Among Participants Who Completed All Visits |
5.0; 5.0; 3.3; 3.6; 2.9; 3.1 | — |
| SECONDARY Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits |
50; 41; 67; 59; 72; 68 | — |
| SECONDARY Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits |
28; 18; 28; 36; 50; 50 | — |
| SECONDARY Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits |
11; 5; 17; 23; 22; 36 | — |
| SECONDARY Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits |
0; 0; 0; 9; 0; 14 | — |
| SECONDARY High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits |
22.8; 25.9; 23.5; 27.0; 4.7; 3.1 | — |
| SECONDARY Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits |
1.29; 1.50; 0.97; 1.10; 0.79; 0.95 | — |
| SECONDARY Percentage of Participants With Improvement of at Least 0.22 Units in M-HAQ Compared to Baseline Per Visit Among Participants Who Completed All Visits |
44.4; 45.5; 72.2; 59.1; 72.2; 54.5 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, at least 18 years of age, inclusive
- Diagnosis of rheumatoid arthritis of at least 6 months duration
- Moderate to severe active rheumatoid arthritis (DAS28 >/=3.2)
- Patients received at least 1 disease-modifying anti-rheumatic drug (DMARD) and/or 1 or more TNFalfa-inhibitors over a period of at least 8 weeks
Exclusion Criteria
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
- Rheumatic autoimmune disease other than rheumatoid arthritis
- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
- Functional class IV (ACR criteria)
- History of severe allergic reaction to human, humanized or murine monoclonal antibodies
- Known active current or history of recurrent infection (including tuberculosis)
- Primary or secondary immunodeficiency (history of or currently active)
- Body weight >150 kg
- Previous treatment with any cell-depleting therapies
- Previous treatment with tocilizumab
Data sourced from ClinicalTrials.gov (NCT01468077). 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.