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Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis (TIARA)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tacrolimus with Methotrexate
Sponsored by
Chong Kun Dang Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, RA, tacrolimus, Disease Activity Score 28, EULAR

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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(PLT) < 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

Sites / Locations

  • Kyung Hee University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tacrolimus with Methotrexate

Arm Description

Subjects have tacrolimus per oral once daily with methotrexate for 24weeks. Tacrolimus increased dosing regimen: 1mg for 0~4 weeks, 2mg for 4 weeks~8 weeks, 3mg for 8 weeks~24 weeks

Outcomes

Primary Outcome Measures

Change from baseline European League Against Rheumatism(EULAR) response at 24weeks

Secondary Outcome Measures

Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks
Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks
Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks
Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks
Change from baseline C-Reactive Protein(CRP) at 16weeks
Change from baseline C-Reactive Protein(CRP) at 24weeks
Change from baseline European League Against Rheumatism(EULAR) response at 16weeks

Full Information

First Posted
December 4, 2012
Last Updated
August 9, 2015
Sponsor
Chong Kun Dang Pharmaceutical
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1. Study Identification

Unique Protocol Identification Number
NCT01746680
Brief Title
Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis
Acronym
TIARA
Official Title
Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chong Kun Dang Pharmaceutical

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
A Phase IV, Open labeled, Multi-Center Trial to Assess the Efficacy and Safety of Tacrolimus(Tacrobell®)in patients with active rheumatoid arthritis(RA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
rheumatoid arthritis, RA, tacrolimus, Disease Activity Score 28, EULAR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus with Methotrexate
Arm Type
Experimental
Arm Description
Subjects have tacrolimus per oral once daily with methotrexate for 24weeks. Tacrolimus increased dosing regimen: 1mg for 0~4 weeks, 2mg for 4 weeks~8 weeks, 3mg for 8 weeks~24 weeks
Intervention Type
Drug
Intervention Name(s)
Tacrolimus with Methotrexate
Other Intervention Name(s)
TacroBell® with MTX
Intervention Description
Tacrolimus 1 mg for 0~week4, 2mg for week4~week8, 3mg for week8~week24 with MTX ≤20mg/week
Primary Outcome Measure Information:
Title
Change from baseline European League Against Rheumatism(EULAR) response at 24weeks
Time Frame
baseline, 24weeks
Secondary Outcome Measure Information:
Title
Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks
Time Frame
baseline, 24weeks
Title
Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks
Time Frame
baseline, 24weeks
Title
Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks
Time Frame
baseline, 16weeks
Title
Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks
Time Frame
baseline, 24eeks
Title
Change from baseline C-Reactive Protein(CRP) at 16weeks
Time Frame
baseline, 16weeks
Title
Change from baseline C-Reactive Protein(CRP) at 24weeks
Time Frame
baseline, 24weeks
Title
Change from baseline European League Against Rheumatism(EULAR) response at 16weeks
Time Frame
baseline, 16weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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(PLT) < 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung -Jae Hong, phD, Dr
Organizational Affiliation
Kyung Hee University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis

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