Niclosamide With Etanercept in Rheumatoid Arthritis

NCT ID: NCT03160001

Last Updated: 2018-12-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-15

Study Completion Date

2018-12-10

Brief Summary

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Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis (RA)

Keywords

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Niclosamide Rheumatoid arthritis diseases activity Efficacy Safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1 patient group and 1 placebo group
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo and etanercept

Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily

Etanercept

Intervention Type DRUG

Etanercept 50mg weekly

Niclosamide and etanercept

Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks

Group Type EXPERIMENTAL

Niclosamide

Intervention Type DRUG

Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks

Etanercept

Intervention Type DRUG

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

Intervention Type DRUG

Niclosamide

Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks

Intervention Type DRUG

Etanercept

Etanercept 50mg weekly

Intervention Type DRUG

Other Intervention Names

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Lactose Enbrel

Eligibility 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Faiq Gorial

OTHER

Sponsor Role lead

Responsible Party

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Faiq Gorial

consultant

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Countries

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Iraq

Other Identifiers

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PRO17050001

Identifier Type: -

Identifier Source: org_study_id