Niclosamide With Etanercept in Rheumatoid Arthritis

Study Overview
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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.

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

Conditions
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Rheumatoid Arthritis (RA)

Intervention / Treatment
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* Drug: Placebo
* Drug: Niclosamide
* Drug: Etanercept


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1 patient group and 1 placebo group
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo and etanercept<br>Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks | Drug: Placebo<br>* Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily<br>* Other names: Lactose;Drug: Etanercept<br>* Etanercept 50mg weekly<br>* Other names: Enbrel;|
| Experimental: Niclosamide and etanercept<br>Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks | Drug: Niclosamide<br>* Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks<br>Drug: Etanercept<br>* Etanercept 50mg weekly<br>* Other names: Enbrel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in disease activity scale | Mean change of disease activity index from baseline using clinical disease activity index (CDAI). | Day 1 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Niclosamide, Rheumatoid arthritis, diseases activity, Efficacy, Safety