Niclosamide With Etanercept in Rheumatoid Arthritis

NCT03160001 — Phase 1 / Phase 2, Completed, 110 participants, Faiq Gorial

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

Registry	NCT03160001
Status	Completed
Phase	Phase 1 / Phase 2
Study type	Interventional; randomized, parallel, masking: double, other
Enrollment	110 (Actual)
Sponsor	Faiq Gorial (Other)
Conditions	Rheumatoid Arthritis (RA)
Interventions	Placebo, Niclosamide, Etanercept (Drug)
Dates	start 2017-08-15, primary completion 2018-08-15, completion 2018-12-10, first posted 2017-05-19, last updated 2018-12-12
Locations	1 site in Iraq

-Summary

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Placebo and etanercept	Placebo comparator	Drug: Placebo; Drug: Etanercept	Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks
Niclosamide and etanercept	Experimental	Drug: Niclosamide; Drug: Etanercept	Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks

Placebo (Drug), also known as Lactose: Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily
Niclosamide (Drug): Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks
Etanercept (Drug), also known as Enbrel: Etanercept 50mg weekly

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Baghdad teaching Hospital	Baghdad	Iraq

+Investigators

Ahmed S Mahmood, MSc, Principal investigator, Baghdad Teaching Hospital

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