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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Chong Kun Dang Pharmaceutical
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01746680
First received: December 4, 2012
Last updated: July 30, 2014
Last verified: December 2012
  Purpose

The aims of this study are to assess the efficacy and safety of tacrolimus in patients with active rheumatoid arthritis(RA). EULAR 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:
  • all cause mortality [ Time Frame: two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated 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 week 24. tacrolimus increased dosing regimen: 1 mg for 0~week4, 2mg for week4~week8,3mg for week8~week24
Drug: Tacrolimus with Methotrexate
TacroBell1® 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).

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • HBsAg positive and anti-HCV positive patient
  • uncontrollable blood sugar(HbA1C ≥8%) or required insulin
  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

Contacts
Contact: Seung Jae Hong, Ph.D 82-2-968-8199 hsj718@khu.ac.kr

Locations
Korea, Republic of
Kyung Hee University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Seung-Jae Hong, Ph.D    82-2-958-8199    hsj718@khu.ac.kr   
Principal Investigator: Seung -Jae Hong         
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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: July 30, 2014
Health Authority: Korea: Food and Drug Administration

Keywords provided by Chong Kun Dang Pharmaceutical:
rheumatoid arthritis
RA
tacrolimus
DAS28
EULAR

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

ClinicalTrials.gov processed this record on August 19, 2014