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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016606
Enrollment
60
Registered
2015-04-01
Start date
2015-04-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis

Interventions

* Evaluate the articular synovitis by gray and power dopplar scale using ultrasound (US). * Injection MTX (5mg/ml, 1ml) into MP or PIP joint using guide of US. After three minutes, perform electropo

Sponsors

Osaka City University Medical School, Department of Orthopedic Surgery
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: * Rheumatoid arthritis (RA) * No limitation of duration of RA * Patient who are recieving standard RA treatment * Patient who are stable disease activity during three months by Methotrexate * Patient who have swelling and tenderness at PIP or MP joint by positive power dopplar of ultrasound * Patient who are stable disease activity during three months by Steroid or biologic agent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Disease activity of local inflammation by Visual Analogue Scale (VAS)

Secondary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactKentaro Inui

Osaka City University Medical School Department of Orthopedic Surgery

inuken@med.osaka-cu.ac.jp06-6645-3852

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026