Niclosamide With Etanercept in Rheumatoid Arthritis

NCT03160001 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PRO17050001
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

Conditions

Rheumatoid Arthritis (RA)

Keywords

Niclosamide; Rheumatoid arthritis; diseases activity; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• Change in disease activity scale

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

  Day 1

Secondary Outcomes (4)

• Change in disease activity score

  Day 2

• disease activity change scale

  Day 3

• The Change in disease activity scale

  24 hours to 48 hours day

• safety of niclosamide

  Day 1

Study Arms (2)

Placebo and etanercept

PLACEBO COMPARATOR

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

Drug: Placebo; Drug: Etanercept

Niclosamide and etanercept

EXPERIMENTAL

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

Drug: Niclosamide; Drug: Etanercept

Interventions

Placebo DRUG

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

Also known as: Lactose

Placebo and etanercept

Niclosamide DRUG

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

Niclosamide and etanercept

Etanercept DRUG

Etanercept 50mg weekly

Also known as: Enbrel

Niclosamide and etanercept; Placebo and etanercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faiq Gorial: lead

Study Sites (1)

Baghdad teaching Hospital

Baghdad, Iraq

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Lactose; Niclosamide; Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars; Salicylanilides; Anilides; Amides; Organic Chemicals; Salicylamides; Aniline Compounds; Amines; Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Ahmed S Mahmood, MSc

  Baghdad Teaching Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: consultant

Model Details: 1 patient group and 1 placebo group

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 19, 2017
• Study Start: August 15, 2017
• Primary Completion: August 15, 2018
• Study Completion: December 10, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)