A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment
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
1 other identifier
interventional
47
2 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 rheumatoid-arthritis
Started Nov 2011
Typical duration for phase_2 rheumatoid-arthritis
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedResults Posted
Study results publicly available
August 17, 2015
CompletedAugust 17, 2015
July 1, 2015
1.8 years
November 7, 2011
June 23, 2015
July 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Any Infusion Reaction
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.
Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20
Secondary Outcomes (15)
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 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 Increased Lipid Values by Visit Among Participants Who Completed All Visits
Screening 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
- +10 more secondary outcomes
Study Arms (2)
Tocilizumab, Normal Administration
EXPERIMENTALTocilizumab 8 mg/kg infusion of 60 minutes duration every 4 weeks for 6 infusions (up to 24 weeks)
Tocilizumab, Fast Administration
EXPERIMENTALTocilizumab 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
Interventions
8 mg/kg infusion
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Aalborg, 9000, Denmark
Unknown Facility
Frederiksberg, 2000, Denmark
Unknown Facility
Hellerup, 2900, Denmark
Unknown Facility
Holbæk, 4300, Denmark
Unknown Facility
Odense, 5000, Denmark
Unknown Facility
Silkeborg, 8600, Denmark
Unknown Facility
Svendborg, 5700, Denmark
Unknown Facility
Reykjavik, 108, Iceland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-LaRoche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 9, 2011
Study Start
November 1, 2011
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
August 17, 2015
Results First Posted
August 17, 2015
Record last verified: 2015-07