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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03160001 |
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Date of registration:
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11/05/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Niclosamide With Etanercept in Rheumatoid Arthritis
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Scientific title:
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Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study |
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Date of first enrolment:
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August 15, 2017 |
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Target sample size:
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110 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03160001 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Iraq
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Contacts
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Name:
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Ahmed S Mahmood, MSc |
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Address:
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Telephone:
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Email:
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Affiliation:
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Baghdad Teaching Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with RA, as defined by the American College of Rheumatology (ACR) 1987
revised criteria or ACR/EULAR 2010,
- Severly Active RA by calculating either DAS28 or SDAI or CDAI.
- Patient selected are those who started etanercept for less than 3months and still
active.
Exclusion Criteria:
- Patients on nonsteroidal anti-inflammatory drugs (NSAID) 2 days before entry into this
study. or methotrexate (MTX)..
- Patients with hypersensitivity or severe adverse effects to niclosamide .
- Renal impairment.
- Hepatic impairment.
- Pregnancy or a desire to become pregnant.
- Breast feeding.
- Patients with Juvenile RA [16 years old or younger].
- Patients using other conventional disease modifying antirheumatic drugs (DMARDs).
- Patients on steroid.
- Patients with coexistence other connective tissue diseases or hypothyroid disease.
- Patient with mild or inactive RA.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis (RA)
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Intervention(s)
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Drug: Niclosamide
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Drug: Etanercept
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Drug: Placebo
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Primary Outcome(s)
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Change in disease activity scale
[Time Frame: Day 1]
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Secondary Outcome(s)
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The Change in disease activity scale
[Time Frame: 24 hours to 48 hours day]
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disease activity change scale
[Time Frame: Day 3]
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Change in disease activity score
[Time Frame: Day 2]
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safety of niclosamide
[Time Frame: Day 1]
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Secondary ID(s)
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PRO17050001
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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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