AzTrials
AzTrials

Rheumatoid ArthritisPhase 4TIARANCT01746680

Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis

A Phase 4 study testing Tacrolimus with Methotrexate in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Tacrolimus with Methotrexate
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteSouth Korea
Study dates
Aug 2012to Jun 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Kyung Hee University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis

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.

Read the 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).

Being tested
Tacrolimus with Methotrexate
Keywords
rheumatoid arthritis, RA, tacrolimus, Disease Activity Score 28, EULAR
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tacrolimus with MethotrexateDrug

    Also called TacroBell® with MTX

    Tacrolimus 1 mg for 0~week4, 2mg for week4~week8, 3mg for week8~week24 with MTX ≤20mg/week

Study groups in NCT01746680
Study groupRoleWhat they receive
Tacrolimus with MethotrexateExperimentalSubjects 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
Receives: Drug: Tacrolimus with Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: baseline, 24weeks

Secondary outcomes (7)

  1. Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks

    Measured: baseline, 24weeks

  2. Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks

    Measured: baseline, 24weeks

  3. Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks

    Measured: baseline, 16weeks

  4. Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks

    Measured: baseline, 24eeks

  5. Change from baseline C-Reactive Protein(CRP) at 16weeks

    Measured: baseline, 16weeks

  6. Change from baseline C-Reactive Protein(CRP) at 24weeks

    Measured: baseline, 24weeks

  7. Change from baseline European League Against Rheumatism(EULAR) response at 16weeks

    Measured: baseline, 16weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746680
Sponsor's protocol ID
m308RAP11M
Acronym
TIARA
Status last verified
Jul 2015
First submitted
4 Dec 2012
Last updated
11 Aug 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tacrolimus with Methotrexate in people with Rheumatoid Arthritis, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline European League Against Rheumatism(EULAR) response at 24weeks (time frame: baseline, 24weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01746680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2015.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in