A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Phase II Multi-centre, Randomized, Parallel Group, Pilot Trial to Compare the Incidence of Tocilizumab Related Infusion Reactions in Moderate to Severe RA Patients When Infusion is Made Over 1 Hour Against 31 Minutes
2 other identifiers
interventional
76
1 country
24
Brief Summary
This 2 arm study will compare the incidence of tocilizumab-related infusion reactions, using 2 different infusion times, in patients with moderate to severe rheumatoid arthritis who have shown an inadequate response to DMARDs (Disease Modifying Anti Rheumatic Drugs) or anti-TNFs.Patients will be randomized to one of 2 groups, to receive tocilizumab 8mg/kg iv every 4 weeks either a)over a 1h infusion time for all administrations or b) a 1h infusion time for the first administration, followed by a 31 minute infusion time for subsequent administrations (unless drug-related infusion reactions occur).The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 rheumatoid-arthritis
Started May 2009
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedResults Posted
Study results publicly available
October 22, 2014
CompletedOctober 22, 2014
October 1, 2014
1.6 years
April 22, 2009
June 26, 2014
October 20, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With an Infusion Reaction Within 24 Hours After Infusion
An infusion reaction was defined as any adverse event (AE) that occurred during the infusion or during the 24 hours following the infusion.
Screening, Baseline, and Weeks 4, 8, 12, 16, 20, and 24
Secondary Outcomes (14)
Percentage of Participants Discontinuing Tocilizumab in Response to an AE or Serious AE (SAE)
Weeks 4, 8, 12, 16, 20 and Final Visit
Percentage of Participants Discontinuing Tocilizumab for Any Reason
Weeks 4, 8, 12, 16, 20 and Final Visit
Percentage of Participants With a Reduction of at Least 1.2 Units on the Disease Activity Scale Based on 28-Joint Count (DAS28) by Visit
Weeks 4, 8, 12, 16, 20 and Final Visit
Percentage of Participants Achieving a DAS28 Score <3.2 by Visit
Weeks 4, 8, 12, 16, 20 and Final Visit
Percentage of Participants Achieving a DAS28 Score <2.6 (Remission)
Weeks 4, 8, 12, 16, 20 and Final Visit
- +9 more secondary outcomes
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
8mg/kg iv every 4 weeks for 6 infusions; first infusion 1h duration, subsequent infusions 31 minutes duration
Eligibility Criteria
You may qualify if:
- adult patients, \>=18 years of age;
- active moderate or severe rheumatoid arthritis;
- active disease for \>6 months;
- inadequate response to a stable dose of non-biologic DMARDs or antiTNFs.
You may not qualify if:
- rheumatic autoimmune disease other than rheumatoid arthritis;
- prior history of, or current inflammatory joint disease other than rheumatoid arthritis;
- major surgery (including joint surgery) within 8 weeks prior to screening, or planned major surgery within 6 months following enrollment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Vitoria-Gasteiz, Alava, 01009, Spain
Unknown Facility
Villajoyosa, Alicante, 03570, Spain
Unknown Facility
Ávila, Avila, 05071, Spain
Unknown Facility
Menorca, Balearic Islands, 07701, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07014, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07198, Spain
Unknown Facility
Badalona, Barcelona, 08915, Spain
Unknown Facility
L'Hospitalet de Llobregat, Barcelona, 08906, Spain
Unknown Facility
Mollet del Vallès, Barcelona, 08100, Spain
Unknown Facility
Torrelavega, Cantabria, 39300, Spain
Unknown Facility
Castellon, Castellon, 12004, Spain
Unknown Facility
Alcalá de Henares, Madrid, 28805, Spain
Unknown Facility
Madrid, Madrid, 28031, Spain
Unknown Facility
Madrid, Madrid, 28935, Spain
Unknown Facility
San Sebastián de los Reyes, Madrid, 28702, Spain
Unknown Facility
Vigo, Pontevedra, 36204, Spain
Unknown Facility
Vigo, Pontevedra, 36214, Spain
Unknown Facility
Gijón, Principality of Asturias, 33394, Spain
Unknown Facility
Oviedo, Principality of Asturias, 33006, Spain
Unknown Facility
Alzira, Valencia, 46600, Spain
Unknown Facility
San Juan, Valencia, 03550, Spain
Unknown Facility
Valenica, Valencia, 46009, Spain
Unknown Facility
Galdakao, Vizcaya, 48960, Spain
Unknown Facility
Zaragoza, Zaragoza, 50009, Spain
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
April 22, 2009
First Posted
April 23, 2009
Study Start
May 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
October 22, 2014
Results First Posted
October 22, 2014
Record last verified: 2014-10