Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy
1 other identifier
interventional
90
1 country
1
Brief Summary
The purpose of this study is to assess the efficacy and safety of tocilizumab vs placebo, in combination with stable, ongoing therapy, with regard to reduction in signs and symptoms in patients with moderate to severe active RA and inadequate response to current DMARD treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 rheumatoid-arthritis
Started Oct 2009
Shorter than P25 for phase_3 rheumatoid-arthritis
1 active site
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
Study Start
First participant enrolled
October 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 29, 2010
CompletedFirst Posted
Study publicly available on registry
September 30, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedNovember 3, 2010
November 1, 2010
1 year
September 29, 2010
November 1, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients with ACR20 responses
Proportion of patients with ACR20 responses at post therapy
24weeks
Secondary Outcomes (2)
Proportion of patients with ACR50 and ACR70 responses at post therapy
24weeks
Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin
24weeks
Study Arms (2)
Tocilizumab 8mg/kg+DMARDs
EXPERIMENTALPlacebo+DMARDs
PLACEBO COMPARATORInterventions
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
Eligibility Criteria
You may qualify if:
- adult patients, \>= 18 years of age
- Active RA of \> 6monts duration
- Received permitted DMARDs each at a stable dose for at least 8 weeks
You may not qualify if:
- Rheumatic autoimmune disease other than RA
- Significant systemic involvement secondary to RA
- ALT or AST \> ULNⅹ1.5
- Platelet count \< 100,000/mm3
- Hemoglobin \< 8.5 g/dL
- White blood cells \< 3,000/mm3
- Absolute neutrophil count \< 2,000/mm3
- Absolute lymphocyte count \< 500/mm3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National Univ. Hospital
Seoul, 110-744, South Korea
Related Publications (1)
Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.
PMID: 32508063DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 29, 2010
First Posted
September 30, 2010
Study Start
October 1, 2009
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
November 3, 2010
Record last verified: 2010-11