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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01746680
Recruitment Status : Completed
First Posted : December 11, 2012
Last Update Posted : August 11, 2015
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Tacrolimus with Methotrexate Phase 4

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis
Study Start Date : August 2012
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline European League Against Rheumatism(EULAR) response at 24weeks [ Time Frame: baseline, 24weeks ]

Secondary Outcome Measures :
  1. Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks [ Time Frame: baseline, 24weeks ]
  2. Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks [ Time Frame: baseline, 24weeks ]
  3. Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks [ Time Frame: baseline, 16weeks ]
  4. Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks [ Time Frame: baseline, 24eeks ]
  5. Change from baseline C-Reactive Protein(CRP) at 16weeks [ Time Frame: baseline, 16weeks ]
  6. Change from baseline C-Reactive Protein(CRP) at 24weeks [ Time Frame: baseline, 24weeks ]
  7. Change from baseline European League Against Rheumatism(EULAR) response at 16weeks [ Time Frame: baseline, 16weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Chong Kun Dang Pharmaceutical Identifier: NCT01746680     History of Changes
Other Study ID Numbers: m308RAP11M
First Posted: December 11, 2012    Key Record Dates
Last Update Posted: August 11, 2015
Last Verified: July 2015

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

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