Niclosamide With Etanercept in Rheumatoid Arthritis

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

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis (RA)
• Intervention / Treatment: Drug: Placebo; Drug: Etanercept; Drug: Niclosamide

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 Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iraq
  • Baghdad, Iraq
    • Baghdad Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: Etanercept; Etanercept 50mg weekly; Other Names: Enbrel; Drug: Niclosamide; Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Faiq Gorial
• Investigators: Principal Investigator: Ahmed S Mahmood, MSc, Baghdad Teaching Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2017
• Primary Completion (Actual): August 15, 2018
• Study Completion (Actual): December 10, 2018

Study Registration Dates

• First Submitted: May 11, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 19, 2017

Study Record Updates

• Last Update Posted (Actual): December 12, 2018
• Last Update Submitted That Met QC Criteria: December 10, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Rheumatoid arthritis; Niclosamide; diseases activity
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Anti-Infective Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Immunosuppressive Agents; Immunologic Factors; Gastrointestinal Agents; Antiparasitic Agents; Antinematodal Agents; Anthelmintics; Antiplatyhelmintic Agents; Anticestodal Agents; Etanercept; Niclosamide
• Other Study ID Numbers: PRO17050001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes