Clinical trial NCT01746680: Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis
Official title: Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
RA
tacrolimus
Disease Activity Score 28
EULAR
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2012-12-11
Enrollment: 111
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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 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.
* 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

Primary outcomes:
measure: Change from baseline European League Against Rheumatism(EULAR) response at 24weeks
timeFrame: baseline, 24weeks
Secondary outcomes:
measure: Change from baseline Simplified Disease Activity Index(SDAI) at 24weeks
timeFrame: baseline, 24weeks
measure: Change from baseline Korean Health Assessment Questionnaire(KHAQ-20) at 24weeks
timeFrame: baseline, 24weeks
measure: Change from baseline Erythrocyte Sedimentation Rate(ESR) at 16weeks
timeFrame: baseline, 16weeks
measure: Change from baseline Erythrocyte Sedimentation Rate(ESR) at 24weeks
timeFrame: baseline, 24eeks
measure: Change from baseline C-Reactive Protein(CRP) at 16weeks
timeFrame: baseline, 16weeks
measure: Change from baseline C-Reactive Protein(CRP) at 24weeks
timeFrame: baseline, 24weeks
measure: Change from baseline European League Against Rheumatism(EULAR) response at 16weeks
timeFrame: baseline, 16weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
Study officials:
affiliation: Kyung Hee University Hospital
name: Seung -Jae Hong, phD, Dr
role: STUDY_CHAIR
References: