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Niclosamide With Etanercept in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis (RA)

Status
Completed
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Placebo
Niclosamide
Etanercept
Sponsored by
Faiq Gorial
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis (RA) focused on measuring Niclosamide, Rheumatoid arthritis, diseases activity, Efficacy, Safety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Baghdad teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo and etanercept

Niclosamide and etanercept

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in disease activity score
Mean change of disease activity index from baseline using simplified disease activity index (SDAI).
disease activity change scale
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
Mean change of disease activity index from baseline using health assessment quality of life (HAQDI).
safety of niclosamide
Number of participants with treatment-related adverse events

Full Information

First Posted
May 11, 2017
Last Updated
December 10, 2018
Sponsor
Faiq Gorial
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1. Study Identification

Unique Protocol Identification Number
NCT03160001
Brief Title
Niclosamide With Etanercept in Rheumatoid Arthritis
Official Title
Adjuvant Use of Niclosamide With Etanercept in Rheumatoid Arthritis: Experimental and Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2017 (Actual)
Primary Completion Date
August 15, 2018 (Actual)
Study Completion Date
December 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Faiq Gorial

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)
Keywords
Niclosamide, Rheumatoid arthritis, diseases activity, Efficacy, Safety

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
1 patient group and 1 placebo group
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo and etanercept
Arm Type
Placebo Comparator
Arm Description
Placebo lactose 500mg cap twice daily with etanercept 50mg weekly for 8 weeks
Arm Title
Niclosamide and etanercept
Arm Type
Experimental
Arm Description
Niclosamide cap 500 mg twice daily with Etanercept 50mg weekly for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Lactose
Intervention Description
Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily
Intervention Type
Drug
Intervention Name(s)
Niclosamide
Intervention Description
Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Etanercept
Other Intervention Name(s)
Enbrel
Intervention Description
Etanercept 50mg weekly
Primary Outcome Measure Information:
Title
Change in disease activity scale
Description
Mean change of disease activity index from baseline using clinical disease activity index (CDAI).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Change in disease activity score
Description
Mean change of disease activity index from baseline using simplified disease activity index (SDAI).
Time Frame
Day 2
Title
disease activity change scale
Description
Mean change of disease activity index from baseline using disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR).
Time Frame
Day 3
Title
The Change in disease activity scale
Description
Mean change of disease activity index from baseline using health assessment quality of life (HAQDI).
Time Frame
24 hours to 48 hours day
Title
safety of niclosamide
Description
Number of participants with treatment-related adverse events
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed S Mahmood, MSc
Organizational Affiliation
Baghdad Teaching Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baghdad teaching Hospital
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

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Niclosamide With Etanercept in Rheumatoid Arthritis

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