Niclosamide With Etanercept in Rheumatoid Arthritis

Phase 1

Completed

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Drug: Placebo; Drug: Niclosamide; Drug: Etanercept

• Registration Number: NCT03160001
• Lead Sponsor: Faiq Gorial

Brief Summary

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

Detailed Description

In this randomized double blind placebo-controlled pilot study (Phase I study) we will assess the efficacy and safety of adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis.

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2017-08-15
• Primary Completion: 2018-08-15
• Status Verified: 2018-12
• Study Completion: 2018-12-10
• Last Update Submitted: 2018-12-10
• Last Update Posted: 2018-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo and etanercept	Placebo	Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks
Niclosamide and etanercept	Etanercept	Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks
Placebo and etanercept	Etanercept	Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks
Niclosamide and etanercept	Niclosamide	Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in disease activity scale	Day 1	Mean change of disease activity index from baseline using clinical disease activity index (CDAI).

Secondary Outcome Measures

Name	Time	Method
Change in disease activity score	Day 2	Mean change of disease activity index from baseline using simplified disease activity index (SDAI).
disease activity change scale	Day 3	Mean change of disease activity index from baseline using disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR).
safety of niclosamide	Day 1	Number of participants with treatment-related adverse events
The Change in disease activity scale	24 hours to 48 hours day	Mean change of disease activity index from baseline using health assessment quality of life (HAQDI).

Trial Locations

Locations (1)

Baghdad teaching Hospital; 🇮🇶 Baghdad, Iraq