Use of Well Known Drugs for New Destination - RA Improvement (RANT) — RANT  

Rheumatoid Arthritis Clinical Trial

Official title: Observational Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Rheumatoid Arthritis Not Responding to Commonly Used Treatments

Status Completed

Clinical Trial Summary

The purpose of this interventional study is to determine whether tetracyclines, statins, antiviral and Vitamin D3 in single subministration are effective in improvement of life and health condition in the treatment of rheumatoid arthritis due to autoimmune disease (RA) in all his forms, specially in patients intolerant to commonly used treatments.

Clinical Trial Description

The purpose of this interventional study is to determine whether tetracyclines, statins, antiviral and Vitamin D3 in single subministration are effective in improvement of life and health condition in the treatment of rheumatoid arthritis due to autoimmune disease (RA) in all his forms, specially in patients intolerant to commonly used treatments.

Has been selected a sample of 15 volunteers (3 cohorts of 5 volunteers) aged between 18 and 75 with diagnosis of RA from a minimum of 2 to a maximum of 20 years and different level of EDSS. The method of analysis chosen was the analysis of the perceived pains with the PAS scale (Pain Assessment Scale) before and after treatment, the analysis of specific joint mobility Kendall before and after treatment and the final EDSS score.

All volunteers were eligible to experimental drug treatment and does not present abnormalities in liver transaminases, renal overload and prolonged use of psychotropic drugs.

The cohorts had defined as goup 1: cohort with new compound drug, group 2: cohort with new compound drug, methotrexate and enbrel, group 3: cohort with methotrexate and enbrel. The treatment had a total duration of 45 days for all groups with three active principles subministration for 2 times a day in group 1 and group 2, methotrexate and enbrel for one injection weekly in group 2 and group 3; controlled nutrition, physiotherapy and gymnastics in all groups.

In the above mentioned groups only the first showed a significant improvement, also if the group 2 has good enhancement, the group 3 showed none improvement.

Considering the above, therefore, seems promising, also because of the low toxicity of the active, non immunosuppressant action and indeed exciting and synergistic action between them in the interests of recovery of homeostasis of the organism, the conduct of a suitable observational trial aimed at demonstrating the ability anti inflammatory and potentially reconstruction of damaged tissues, specially in patients that show not optimal response to commonly used treatments. So we would use this results to patent a new drug for rheumatoid arthritis treatment and begin a large range study. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute and Chronic Inflammation
• Arthritis
• Arthritis, Rheumatoid
• Autoimmune Diseases
• Disease
• Disorder of Pleura and Pleural Cavity
• Disorder of Synovium
• Felty Syndrome
• Felty's Syndrome
• Inflammation
• Pleural Diseases
• Rheumatoid Arthritis
• Rheumatoid Nodule
• Rheumatoid Nodules
• Sjogren's Syndrome
• Syndrome

• NCT number: NCT02633332
• Study type: Interventional
• Source: Università Popolare Homo & Natura
• Status: Completed
• Phase: Phase 1
• Start date: February 2015
• Completion date: November 2015