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
ClinicalTrials.gov Identifier:
First received: December 4, 2012
Last updated: August 9, 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.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tacrolimus with Methotrexate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis

Resource links provided by NLM:

Further study details as provided by Chong Kun Dang Pharmaceutical:

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 ]

Enrollment: 111
Study Start Date: August 2012
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus with Methotrexate
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
Drug: Tacrolimus with Methotrexate
Tacrolimus 1 mg for 0~week4, 2mg for week4~week8, 3mg for week8~week24 with MTX ≤20mg/week
Other Name: TacroBell® with MTX

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).

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746680

Korea, Republic of
Kyung Hee University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Study Chair: Seung -Jae Hong, phD, Dr Kyung-Hee University Hospital
  More Information

No publications provided

Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT01746680     History of Changes
Other Study ID Numbers: m308RAP11M
Study First Received: December 4, 2012
Last Updated: August 9, 2015
Health Authority: Korea: Ministry of Food and Drug Safety

Keywords provided by Chong Kun Dang Pharmaceutical:
rheumatoid arthritis
Disease Activity Score 28

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on December 01, 2015