- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01224418
A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
October 19, 2010 updated by: Astellas Pharma Inc
Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study
This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Phase 4
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
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Gyeonggido, Korea, Republic of
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Seoul, Korea, Republic of
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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
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria
- Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator
- ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein)
- Patients are required to have at least 3 of 66 joints assessed as swollen
- Patients are required to have at least 6 of 68 joints assessed as painful with pressure
Exclusion Criteria:
- Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
- Previous experience of tacrolimus (ointment excluded)
- Renal impairment or serum creatinine > 1.4 mg/dL
- Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT > 2x upper limit normal
- Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level >110mg/dl before the meal and >200mg/dl after the meal HbA1c > 6.4%
- Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
- Other investigational drug within last 30 days
- Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Tacrolimus group
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oral
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ACR20 response rate compared to baseline
Time Frame: Baseline and up to 6 months
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(ACR20: 20% improvement in American College of Rheumatology Core Set)
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Baseline and up to 6 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
ACR50 response rate compared to baseline
Time Frame: Baseline and up to 6 months
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Baseline and up to 6 months
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ACR70 response rate compared to baseline
Time Frame: Baseline and up to 6 months
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Baseline and up to 6 months
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Changes from baseline in 100mm pain VAS (Visual Analogue Scale)
Time Frame: Baseline and up to 6 months
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Baseline and up to 6 months
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Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test
Time Frame: For 6 months
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For 6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
October 14, 2010
First Submitted That Met QC Criteria
October 19, 2010
First Posted (Estimate)
October 20, 2010
Study Record Updates
Last Update Posted (Estimate)
October 20, 2010
Last Update Submitted That Met QC Criteria
October 19, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
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
- Enzyme Inhibitors
- Immunosuppressive Agents
- Immunologic Factors
- Calcineurin Inhibitors
- Tacrolimus
Other Study ID Numbers
- PRGRA-08-01-KOR
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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Clinical Trials on Tacrolimus
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-
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Taro Pharmaceuticals USACompleted
-
Peking Union Medical College HospitalUnknown
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Technical University of MunichCompleted
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Limerick BioPharmaCompleted
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