Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
110 participants
INTERVENTIONAL
2017-08-15
2018-12-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo and etanercept
Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks
Placebo
Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily
Etanercept
Etanercept 50mg weekly
Niclosamide and etanercept
Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks
Niclosamide
Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks
Etanercept
Etanercept 50mg weekly
Interventions
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Placebo
Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily
Niclosamide
Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks
Etanercept
Etanercept 50mg weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Faiq Gorial
OTHER
Responsible Party
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Faiq Gorial
consultant
Principal Investigators
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Ahmed S Mahmood, MSc
Role: PRINCIPAL_INVESTIGATOR
Baghdad Teaching Hospital
Locations
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Baghdad teaching Hospital
Baghdad, , Iraq
Countries
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Other Identifiers
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PRO17050001
Identifier Type: -
Identifier Source: org_study_id