- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01347983
Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients
April 3, 2013 updated by: Chugai Pharma Taiwan
24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chiayi, Taiwan
- Buddhist Dalin Tzu Chi General Hospital
-
Kaohsiung, Taiwan
- Kaohsiung Medical University Hospital
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Kaohsiung, Taiwan
- Kaohsiung Veterans General Hospital
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Kaohsiung, Taiwan
- Chang Gung Memorial Hospital -Kaohsiung
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Taichung, Taiwan
- Taichung Veterans General Hospital
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Taichung, Taiwan
- Chung Shan Medical University Hospital
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Tainan, Taiwan
- National Cheng Kung University Hospital
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Taipei, Taiwan
- Tri-Service General Hospital
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Taipei, Taiwan
- National Taiwan University Hospital
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Taipei, Taiwan
- Taipei Veterans General Hospital
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Taipei, Taiwan
- Cathay General Hospital
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Taoyuan, Taiwan
- Chang Gung Memorial Hospital - Linkou
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab Phase IIIb study(MRA230TW).
- Patients assigned in the Phase IIIb study(MRA230TW), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by ACR20
Exclusion Criteria:
- Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
- Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
- Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
- Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
- Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand & foot fungal infections can participate.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with an American College of Rheumatology 70 (ACR70) response
Time Frame: at week 24
|
at week 24
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Proportion of patients with ACR50 response
Time Frame: at week 24
|
at week 24
|
Proportion of patients with ACR20 response
Time Frame: at week 24
|
at week 24
|
Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
Time Frame: at baseline and week 24
|
at baseline and week 24
|
Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
Time Frame: at baseline and week 24
|
at baseline and week 24
|
Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
Time Frame: at week 24
|
at week 24
|
Adverse event incidence
Time Frame: from baseline to week 24
|
from baseline to week 24
|
Mean change from baseline to evaluation visits in vital signs
Time Frame: from baseline to week 24
|
from baseline to week 24
|
Change in Electrocardiogram. From baseline to evaluation visits
Time Frame: from baseline to week 24
|
from baseline to week 24
|
Mean change from baseline visit to evaluation visits in quantitative hematological exam results.
Time Frame: from baseline to week 24
|
from baseline to week 24
|
Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results.
Time Frame: from baseline to week 24
|
from baseline to week 24
|
Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
Time Frame: from baseline to week 24
|
from baseline to week 24
|
Mean change from baseline visit to evaluation visits in quantitative urinalysis results.
Time Frame: from baseline to week 24
|
from baseline to week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Yoshiaki Someya, Chugai Pharma Taiwan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
March 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
May 3, 2011
First Submitted That Met QC Criteria
May 4, 2011
First Posted (Estimate)
May 5, 2011
Study Record Updates
Last Update Posted (Estimate)
April 4, 2013
Last Update Submitted That Met QC Criteria
April 3, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Reproductive Control Agents
- Abortifacient Agents, Nonsteroidal
- Abortifacient Agents
- Folic Acid Antagonists
- Methotrexate
Other Study ID Numbers
- MRA230TW EX
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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