Evaluation of regulatory T cell and disease activity after transdermal administration of Dovonex(r) ointment 50ug/g in patients with rheumatoid arthritis

Not Applicable

• Conditions: Rheumatoid arthritis

• Registration Number: JPRN-UMIN000022296
• Lead Sponsor: Medical Co.LTA PS Clinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-15
• Study Completion: 2016-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up continuing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1, Patients with other systemic autoimmune disease (e.g. systemic erythematosus). 2, Patients with history of hypersensitivity to Calcipotriol. 3, Patients with or with the risk of hypercalcemia, or whose serum calcium level exceed normal range. 4, Patients currently treated with Calcineurin antagonist (Cyclosporine or Tacrolimus). 5, Patients currently treated with anti-osteoporosis drugs (Vitamin D3, PTH). 6, Patients whose eGFR is 60 or lower. 7, Patients treated for bacterial infection within 30 days prior to the first administration of the study drug. 8, Uncooperative patients who might not comply with the protocol procedure. 9, Patients with malignant tumor requiring treatment within past 5 years. 10, Patients judged inappropriate for this study by principal investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change of Treg are evaluated before and 8 days after transermal administration of Dovonex(r) ointment 50ug/g.

Secondary Outcome Measures

Name	Time	Method
Evaluate change in disease activity using RA activity indexes