Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis (TIARA)
This study is currently recruiting participants.
Verified December 2012 by Chong Kun Dang Pharmaceutical
Sponsor:
Chong Kun Dang Pharmaceutical
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01746680
First received: December 4, 2012
Last updated: December 9, 2012
Last verified: December 2012
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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: | December 2013 |
| Estimated Primary Completion Date: | August 2013 (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
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: | December 9, 2012 |
| 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 May 22, 2013