Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis (TIARA)
This study has been completed.
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
First received: December 4, 2012
Last updated: July 30, 2015
Last verified: July 2015
The aims of this study are to assess the efficacy and safety of tacrolimus in patients with active rheumatoid arthritis(RA). EULAR(European League Against Rheumatism) response at week 24 compared to baseline will be evaluated to assess the efficacy of Tacrolimus.
Drug: Tacrolimus with Methotrexate
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis
Primary Outcome Measures:
- Change from baseline European League Against Rheumatism(EULAR) response at 24weeks [ Time Frame: baseline, 24weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks [ Time Frame: baseline, 24weeks ] [ Designated as safety issue: No ]
- Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks [ Time Frame: baseline, 24weeks ] [ Designated as safety issue: No ]
- Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks [ Time Frame: baseline, 16weeks ] [ Designated as safety issue: No ]
- Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks [ Time Frame: baseline, 24eeks ] [ Designated as safety issue: No ]
- Change from baseline C-Reactive Protein(CRP) at 16weeks [ Time Frame: baseline, 16weeks ] [ Designated as safety issue: No ]
- Change from baseline C-Reactive Protein(CRP) at 24weeks [ Time Frame: baseline, 24weeks ] [ Designated as safety issue: No ]
- Change from baseline European League Against Rheumatism(EULAR) response at 16weeks [ Time Frame: baseline, 16weeks ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||June 2015 (Final data collection date for primary outcome measure)
Experimental: Tacrolimus with Methotrexate
Subjects have tacrolimus per oral once daily with methotrexate for week 24. tacrolimus increased dosing regimen: 1 mg for 0~week4, 2mg for week4~week8,3mg for week8~week24
Drug: Tacrolimus with Methotrexate
TacroBell® 1 mg for 0~week4, 2mg for week4~week8, 3mg for week8~week24 with MTX ≤20mg/week
Other Name: TacroBell® with Methotrexate
A Phase IV, Open labeled, Multi-Center Trial to Assess the Efficacy and Safety of Tacrolimus(Tacrobell®)in patients with active rheumatoid arthritis(RA).
|Ages Eligible for Study:
||20 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male or female aged ≥20years
- Signed and dated informed consent document indicating that the patient
- Women of childbearing potential must have a negative serum or urine pregnancy test at the screening visit. Except in the case of surgically sterile or amenorrhea for one year.
- Female patients must agree to use adequate contraception measures during the period of therapy which should be continued for 4 weeks.
- have RA and meet all of the following criteria; RA occurring ≥ 3months and less than 15 years and diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis; Active RA patients with MTX and among them who has insufficiency response to DMARDs as defined DAS28>3.2 in active RA patient. Insufficiency response is defined despite MTX therapy for > 12 weeks, RA activity≥ more than moderate and confirmable during 12 weeks, sequence of taking MTX >7.5mg/week for more than 6 weeks; ESR≥28mm/h or CRP≥1.0mg/dl; Tender Joint Counts must be more than 6 and Swollen Joint Counts must be more than 3
- Inflammatory joint diseases, Systematic inflammatory disease
- Prosthesis and had an event of infected in it.
- Medical history of chronic infection, moderate infection or possibly to life threatening or signs and symptoms of serious infection.
- Patients have received treatment with a live vaccine from baseline within 8 weeks.
- HBsAg positive and hepatitis C virus positive patient.
- Patients have a history of malignancy. (But, carcinoma in situ of the uterine cervix or basal cell carcinoma have been treated is allowed within 5years)
- Patients have cardiovascular disease or associated disease which is not controlled.
- uncontrollable blood sugar(HbA1C ≥8%) or required insulin.
- Patients with a history of operation on index knee joint which could have influence on the result and need to have surgery as determined by investigator.
- At screening, patients have laboratory result as defined by ; white blood cell(WBC) < 3,500/mm3, Absolute Neutrophil Count(ANC) < 1,500/mm3, Hemoglobin < 8.5g/dl, Platelet count(PTL) < 100,000/mm3, Serum creatinine >1.5*upper limit of normal or 2mg/dl, Total bilirubin > 2*upper limit of normal, aspartate aminotransferase(AST) > 2*upper limit of normal, alanine aminotransferase(ALT) > 2*upper limit of normal, alkaline phosphatase(ALP) > 2*upper limit of normal
- Patients on any other clinical trial or experimental treatment in the past 8weeks
- An impossible one who participates in clinical trial by investigator's decision
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01746680
|Kyung Hee University Hospital
|Seoul, Korea, Republic of |
Chong Kun Dang Pharmaceutical
||Seung -Jae Hong, phD, Dr
||Kyung-Hee University Hospital
No publications provided
||Chong Kun Dang Pharmaceutical
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 4, 2012
||July 30, 2015
||Korea: Ministry of Food and Drug Safety
Keywords provided by Chong Kun Dang Pharmaceutical:
Disease Activity Score 28
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 30, 2015
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