Back to resultsEfficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tocilizumab
DMARDs
Placebo
DMARDs
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- adult patients, >= 18 years of age
- Active RA of > 6monts duration
- Received permitted DMARDs each at a stable dose for at least 8 weeks
Exclusion Criteria:
- 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
Sites / Locations
- Seoul National Univ. Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tocilizumab 8mg/kg+DMARDs
Placebo+DMARDs
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with ACR20 responses
Proportion of patients with ACR20 responses at post therapy
Secondary Outcome Measures
Proportion of patients with ACR50 and ACR70 responses at post therapy
Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01211834
Brief Title
Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
JW Pharmaceutical
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tocilizumab 8mg/kg+DMARDs
Arm Type
Experimental
Arm Title
Placebo+DMARDs
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
tocilizumab
Intervention Description
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
Intervention Type
Drug
Intervention Name(s)
DMARDs
Intervention Description
Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intravenously over 1 hour infusion every 4weeks
Intervention Type
Drug
Intervention Name(s)
DMARDs
Intervention Description
Methotrexate(MTX) and/or 1 DMARDs
Primary Outcome Measure Information:
Title
Proportion of patients with ACR20 responses
Description
Proportion of patients with ACR20 responses at post therapy
Time Frame
24weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with ACR50 and ACR70 responses at post therapy
Time Frame
24weeks
Title
Change of DAS28, HAQ, individual parameter in ACR core set, hemoglobin
Time Frame
24weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult patients, >= 18 years of age
Active RA of > 6monts duration
Received permitted DMARDs each at a stable dose for at least 8 weeks
Exclusion Criteria:
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
Facility Information:
Facility Name
Seoul National Univ. Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
32508063
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
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