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

Rheumatoid Arthritis Clinical Trial

— RANT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02633332
• Other study ID #: HN2_2015
• Status: Completed
• Phase: Phase 1
• First received: November 30, 2015
• Last updated: December 14, 2015
• Start date: February 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Università Popolare Homo & Natura
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: November 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of Rheumatoid Arthritis

• EDSS score from 2 to 7,5

• PAS (Pain Assessment Scale) score from 2 to 9

Exclusion Criteria:

• Liver diseases: GOT GPT = 40

• Kidney diseases: Creatinine > 1,50

• Use of psychotropic drugs

• Other musculoskeletal diagnoses, unstable cardiovascular, respiratory, metabolic or other conditions that would interfere with this 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

Intervention

Drug:
• Vitamin D3
every 12 hours, orally form
• Lipitor®
every 12 hours, orally form
• Acycloguanosine
every 12 hours, orally form
• Tetracycline
every 12 hours, orally form
• methotrexate
every week, subcutaneous injection
• etanercept
every week, subcutaneous injection

Locations

Country	Name	City	State
Italy	Centro Medico Forme di Bellezza	Terni	TR

Sponsors (1)

Lead Sponsor	Collaborator
Università Popolare Homo & Natura

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Disability level at 45 days	use of EDSS (expanded disability status scale)	baseline - 45 days	No
Secondary	Change from baseline in Muscle imbalance level at 45 days	use of Kendall Test	baseline - 45 days	No
Secondary	Change from baseline in Pain perceived level at 45 days	use of PAS (Pain Assessment Scale)	baseline - 45 days	No