Niclosamide With Etanercept in Rheumatoid Arthritis

Sponsor

Faiq Gorial (Other)

Overall Status

Completed

CT.gov ID

NCT03160001

Collaborator

(none)

110

Enrollment

Location

Arms

15.8

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis (RA)	Drug: Placebo Drug: Niclosamide Drug: Etanercept	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

1 patient group and 1 placebo group1 patient group and 1 placebo group

Masking:

Double (Participant, Investigator)

Primary Purpose:

Other

Official Title:

Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study

Actual Study Start Date :

Aug 15, 2017

Actual Primary Completion Date :

Aug 15, 2018

Actual Study Completion Date :

Dec 10, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo and etanercept Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks	Drug: Placebo Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily Other Names: Lactose Drug: Etanercept Etanercept 50mg weekly Other Names: Enbrel
Experimental: Niclosamide and etanercept Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks	Drug: Niclosamide Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks Drug: Etanercept Etanercept 50mg weekly Other Names: Enbrel

Arm

Intervention/Treatment

Placebo Comparator: Placebo and etanercept

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

Drug: Placebo

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

Other Names:

Lactose

Drug: Etanercept

Etanercept 50mg weekly

Other Names:

Enbrel

Experimental: Niclosamide and etanercept

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

Drug: Niclosamide

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

Drug: Etanercept

Etanercept 50mg weekly

Other Names:

Enbrel

Outcome Measures

Primary Outcome Measures

Change in disease activity scale [Day 1]
Mean change of disease activity index from baseline using clinical disease activity index (CDAI).

Secondary Outcome Measures

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).
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).
safety of niclosamide [Day 1]
Number of participants with treatment-related adverse events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.