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Completed

NCT Number: NCT03160001

Niclosamide With Etanercept in Rheumatoid Arthritis

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Baghdad teaching Hospital

Baghdad, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Placebo

Drug

Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily

Other names: Lactose

Niclosamide

Drug

Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks

etanercept

Drug

Etanercept 50mg weekly

Other names: Enbrel

Primary outcomes

  1. Change in disease activity scale

    Time frame: Day 1

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

Secondary outcomes

  1. Change in disease activity score

    Time frame: Day 2

    Mean change of disease activity index from baseline using simplified disease activity index (SDAI).

  2. disease activity change scale

    Time frame: Day 3

    Mean change of disease activity index from baseline using disease activity score 28 joints-erythrocyte sedimentation rate (DAS28-ESR).

  3. The Change in disease activity scale

    Time frame: 24 hours to 48 hours day

    Mean change of disease activity index from baseline using health assessment quality of life (HAQDI).

  4. safety of niclosamide

    Time frame: Day 1

    Number of participants with treatment-related adverse events

Sponsors and collaborators

Lead sponsor

Faiq Gorial

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 19, 2017
Registry last updated
Dec 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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