Efficacy and safety of electroporation and MTX combination therapy for the patients with RA

Phase 2

• Conditions: rheumatoid arthritis

• Registration Number: JPRN-UMIN000016606
• Lead Sponsor: Osaka City University Medical School, Department of Orthopedic Surgery

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

* Patient who had a history of hypersensitivity for Methotrexate * Patient who have history of implantation and metallic material * Patient who had a significant unstable RA disease status * Patients who have infection disease * Patient who was pregnant, planning on becoming pregnant or breast feeding Patient who had a history of seizures

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease activity of local inflammation by Visual Analogue Scale (VAS)

Secondary Outcome Measures

Name	Time	Method
1. Ultrasound assessment: Gray and power dopplar scale of local site. 2. Disease activity assessment: Mean value of DAS28, Mean change from baseline of DAS28. 3. Joint destruction: Change of modified Total Sharp Score (mTSS) from baseline.