Niclosamide With Etanercept in Rheumatoid Arthritis

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03160001
• Other study ID #: PRO17050001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 15, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: December 2018
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: December 10, 2018
• Est. primary completion date: August 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• Placebo
Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily
• Niclosamide
Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks
• Etanercept
Etanercept 50mg weekly

Locations

Country	Name	City	State
Iraq	Baghdad teaching Hospital	Baghdad

Sponsors (1)

Lead Sponsor	Collaborator
Faiq Gorial

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in disease activity scale	Mean change of disease activity index from baseline using clinical disease activity index (CDAI).	Day 1
Secondary	Change in disease activity score	Mean change of disease activity index from baseline using simplified disease activity index (SDAI).	Day 2
Secondary	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
Secondary	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
Secondary	safety of niclosamide	Number of participants with treatment-related adverse events	Day 1