Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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28 December 2015 |
Main ID: |
NCT02633332 |
Date of registration:
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30/11/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Use of Well Known Drugs for New Destination - RA Improvement (RANT)
RANT |
Scientific title:
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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 |
Date of first enrolment:
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February 2015 |
Target sample size:
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15 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT02633332 |
Study type:
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Interventional |
Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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Italy
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Contacts
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Name:
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Pierluigi Proietti, M.D. |
Address:
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Telephone:
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Email:
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Affiliation:
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Forme di Bellezza s.r.l. |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute and Chronic Inflammation
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Rheumatoid Arthritis
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Autoimmune Diseases
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Felty's Syndrome
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Disorder of Pleura and Pleural Cavity
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Rheumatoid Nodules
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Disorder of Synovium
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Sjogren's Syndrome
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Intervention(s)
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Drug: etanercept
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Drug: Lipitor®
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Drug: Vitamin D3
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Drug: methotrexate
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Drug: Acycloguanosine
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Drug: Tetracycline
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Primary Outcome(s)
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Change from baseline in Disability level at 45 days
[Time Frame: baseline - 45 days]
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Secondary Outcome(s)
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Change from baseline in Muscle imbalance level at 45 days
[Time Frame: baseline - 45 days]
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Change from baseline in Pain perceived level at 45 days
[Time Frame: baseline - 45 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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