To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis
Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study
1 other identifier
interventional
89
1 country
1
Brief Summary
The purpose of this study is to evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.
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 Mar 2010
Typical duration 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
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 28, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 20, 2013
November 1, 2013
1.8 years
October 28, 2010
November 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Safety results
1. All AE/ADR during study 2. Physical examination including vital signs and ECG 3. Clinical laboratory results
48weeks
Secondary Outcomes (5)
Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy
48weeks
Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy
48weeks
Change of individual parameter in ACR core set
48weeks
Change of individual parameter in DAS28
48weeks
Change of individual parameter in Rheumatoid factor
48 weeks
Study Arms (1)
Tocilizumab 8mg/kg + DMARDs
EXPERIMENTALInterventions
intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
Eligibility Criteria
You may not qualify if:
- Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
- Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
- Willing to give written informed consent
- History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
- ALT or AST \> ULNⅹ2.5
- Platelet count \< 100ⅹ103/ μL
- WBC \< 3,000/mm3
- Absolute neutrophil count \< 1,000/mm3
- Absolute lymphocyte count \< 500/mm3
- Total bilirubin \> ULNⅹ2
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2010
First Posted
December 9, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2011
Study Completion
November 1, 2013
Last Updated
November 20, 2013
Record last verified: 2013-11