Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis

NCT01746680 | Completed Phase 4 DMC

• 1 other identifier: m308RAP11M
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; RA; tacrolimus; Disease Activity Score 28; EULAR

Outcome Measures

Primary Outcomes (1)

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

  baseline, 24weeks

Secondary Outcomes (7)

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

  baseline, 24weeks

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

  baseline, 24weeks

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

  baseline, 16weeks

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

  baseline, 24eeks

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

  baseline, 16weeks

Study Arms (1)

Tacrolimus with Methotrexate

EXPERIMENTAL

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

Interventions

Tacrolimus with Methotrexate DRUG

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

Also known as: TacroBell® with MTX

Tacrolimus with Methotrexate

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Kyung Hee University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Tacrolimus; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Seung -Jae Hong, phD, Dr

  Kyung Hee University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 11, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: August 11, 2015

Record last verified: 2015-07

Locations

KR (1)