Clinical trial NCT01468077: A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of Participants With Any Infusion Reaction
timeFrame: Baseline (Day 1), and Weeks 4, 8, 12, 16, and 20
Secondary outcomes:
measure: Percentage of Participants Discontinuing Tocilizumab in Response to an AE or a Serious Adverse Event (SAE)
timeFrame: Baseline (Day 1) and Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Discontinuing Tocilizumab for Other Reasons
timeFrame: Baseline and Weeks, 4, 8, 12, 16, 20, and 24
measure: 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
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With Increased Lipid Values by Visit Among Participants Who Completed All Visits
timeFrame: Screening and Weeks 4, 8, 12, 16, 20, and 24
measure: 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
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving a DAS28 Score Below 3.2 (Low Disease Activity) by Visit Among Participants Who Completed All Visits
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving a DAS28 Score Below 2.6 (Remission) by Visit Among Participants Who Completed All Visits
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: DAS28 Score by Visit Among Participants Who Completed All Visits
timeFrame: Baseline, Weeks, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving American College of Rheumatology 20 Percent (%) Improvement (ACR20 Response) by Visit Among Participants Who Completed All Visits
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) by Visit Among Participants Who Completed All Visits
timeFrame: Weeks, 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) by Visit, Among Participants Who Completed All Visits
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: Percentage of Participants Achieving ACR 90% Improvement (ACR90 Response) by Visit Among Participants Who Completed All Visits
timeFrame: Weeks 4, 8, 12, 16, 20 and 24
measure: High Sensitivity C-Reactive Protein (hsCRP) Levels by Visit Among Participants Who Completed All Visits
timeFrame: Screening, Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: Modified Health Assessment Questionnaire (M-HAQ) Score by Visit Among Participants Who Completed All Visits
timeFrame: Baseline, Weeks 4, 8, 12, 20, and 24
measure: 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
timeFrame: Weeks 4, 8. 12, 20, and 24
Other outcomes:
Locations:
city: Alborg
country: Denmark
city: Frederiksberg
country: Denmark
city: Hellerup
country: Denmark
city: Holbæk
country: Denmark
city: Odense
country: Denmark
city: Silkeborg
country: Denmark
city: Svendborg
country: Denmark
city: Reykjavik
country: Iceland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: