Multicenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 Hour

Hoffmann-La Roche0 sites47 target enrollmentNovember 2011

ConditionsRheumatoid Arthritis

InterventionsTocilizumab

DrugsTocilizumab

Overview

Phase: Phase 2
Intervention: Tocilizumab
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 47
Primary Endpoint: Percentage of Participants With Any Infusion Reaction
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2011

End Date

September 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Arms & Interventions

Tocilizumab, Normal Administration

Tocilizumab 8 mg/kg infusion of 60 minutes duration every 4 weeks for 6 infusions (up to 24 weeks)

Intervention: Tocilizumab

Tocilizumab, Fast Administration

Tocilizumab 8 mg/kg infusion of 31 minutes duration every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour. If an infusion reaction occurred during any treatment, 1 hour infusions were used for all subsequent infusions

Intervention: Tocilizumab

Outcomes

Primary Outcomes

Percentage of Participants With Any Infusion Reaction

Time Frame: Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20

An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion and deemed possibly or probably related to tocilizumab.

Secondary Outcomes

Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)(Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24)
Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20 and 24)
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(Weeks 4, 8. 12, 20, and 24)
Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20, and 24)
Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits(Weeks, 4, 8, 12, 16, 20, and 24)
High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits(Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24)
Percentage of Participants Discontinuing Tocilizumab for Other Reasons(Baseline and Weeks, 4, 8, 12, 16, 20, and 24)
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(Baseline and Weeks 4, 8, 12, 16, 20, and 24)
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(Weeks 4, 8, 12, 16, 20, and 24)
Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits(Screening and Weeks 4, 8, 12, 16, 20, and 24)
Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20, and 24)
DAS28 Score by Visit Among Participants Who Completed All Visits(Baseline, Weeks, 4, 8, 12, 16, 20, and 24)
Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20, and 24)
Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits(Weeks 4, 8, 12, 16, 20 and 24)
Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits(Baseline, Weeks 4, 8, 12, 20, and 24)