Switching to Tacrolimus from TNF inhibitor in RA

Not Applicable

Completed

• Conditions: Diseases of the musculo-skeletal system and connective tissue

• Registration Number: KCT0005868
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 162

Inclusion Criteria

1) Patients with RA for at least 12 months to less than 15 years
2) 20–70 years of age at the time of the screening visit
3) Patients who received TNFi for =24 weeks and had DAS28-CRP < 3.2 for = 12 consecutive weeks before screening
4) Subjects who can understand the information provided to them and who can voluntarily sign written consent
5) Subjects who understand the difference between tacrolimus treatment and TNFi treatment and can choose their treatment
6) If a female of child-bearing age, a negative pregnancy test at the time of the screening visit
A.For female subjects, there must be at least one year of menopause, surgical sterilization, or effective use of acceptable contraception methods. For contraception, subjects must agree to use an appropriate method during the clinical trial period and for 12 weeks after the end of administration of the investigational drug.
B.For male subjects, the subject or subject's female partner must agree to use an appropriate method of contraception during the trial period and for 12 weeks after the end of the investigational drug administration.
7) Subjects with LDA (as defined below) at screening and baseline:
A. Stable treatment with TNFi and MTX for =24 weeks without alterations in dose and interval for =12 weeks
B. ESR <28 mm/h or CRP <10 mg/dL for at least 4 consecutive weeks before screening
C. Tender and swollen joint count = 5 for at least 4 consecutive weeks before screening
8) Subjects who received TNFi and MTX treatment (regardless of folic acid administration) for at least 24 weeks prior to baseline visit. The minimum acceptable stabilizing dose of MTX is 7.5 mg per week.

Exclusion Criteria

1) Subjects diagnosed with other forms of inflammatory arthritis (e.g., psoriatic arthritis, ankylosing spondylitis, or reactive arthritis)
2) Subjects with secondary noninflammatory arthritis (e.g., osteoarthritis or fibromyalgia) with symptoms sufficient to interfere with evaluation of the efficacy of the investigational drug for the main diagnosed RA disease, in the opinion of the investigator
3) Subjects who continue to have prostheses that have been infected at least once

Exclusion criteria for concomitant drugs
Subjects who have used the following medications for a certain period before the baseline visit

Exclusion criteria related to medical history
1) Female subjects who are lactating, pregnant, or planning to become pregnant during the clinical trial period or for 12 weeks after the administration of the investigational drug
2) Subjects with a history of chronic infection, recent severe infection, or life-threatening infection (within 24 weeks, including shingles), or signs or symptoms that may be considered infection (e.g., fever, cough)
3) In the opinion of the investigator, subjects with high risk of infection
4) Subjects who received any live vaccine within 8 weeks prior to baseline visit
5) Subjects known to be infected with HIV
6) Subjects with a history of lymphoma or lymphoproliferative disease, or subjects with signs and symptoms suggestive of lymphoproliferative disease
7) Subjects with active malignancies or a history of malignant tumors. However, cervical cancer or basal cell carcinoma that has completely responded to treatment for >5 years before screening is allowed.
8) Subjects with a current or recent history of severe, ongoing, and/or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, or brain disease and deemed inappropriate for clinical trial selection by the investigator.
9) Subjects with NYHA grade III or IV congestive heart failure
10) Subjects diagnosed with systemic inflammatory diseases (e.g., scleroderma, systemic lupus erythematosus, and mixed connective tissue disease)
11) Subjects with positive hepatitis B surface antigen test and/or hepatitis C antibody test results
12) Subjects with current or history of central nervous system disease, demyelinating disease, or convulsive disease (e.g., multiple sclerosis, and epilepsy)
13) Subjects who are scheduled for or need a surgical joint procedure
14) Persons considered to be unsuitable for participation in clinical trials by the investigator for other reasons such as alcohol or drug abuse
15) Subjects with pancreatitis or diabetes history or complications
16) Patients with genetic problems such as lactose intolerance and glucose-galactose malabsorption
17) Subjects whose clinical laboratory test results show one of the following, or who exhibit abnormal clinical laboratory test values considered to be clinically meaningful by the investigator
A.WBC < 3,500/mm3
B.Neutrophils < 1,500/mm3
C.Hemoglobin < 8.5 g/dL
D.Platelet count < 100,000/mm3
E.Serum creatinine > 1.5 × the upper normal limit or 2 mg/dL (whichever is smaller)
F.Total bilirubin > 2 × the upper normal limit
G.AST > 2 × the upper normal limit
H.ALT > 2 × the upper normal limit
I.ALP > 2 × the upper normal limit
J.Glucose: Fasting > 110 mg/dL or postprandial > 200 mg/dL
18)Subjects who are not cooperative with or are unable to follow the clinical trial procedure

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who maintain LDA

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who maintain LDA;Remission rate;Changes in HAQ-DI