Niclosamide With Etanercept in Rheumatoid Arthritis

Faiq Gorial

Status and phase: Completed; Phase 2; Phase 1

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: Etanercept; Drug: Placebo; Drug: Niclosamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03160001

PRO17050001

Details and patient eligibility

About

Assessment of the adjuvant use Niclosamide With Etanercept in Rheumatoid Arthritis

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups, including a placebo group

Placebo and etanercept

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Drug: Etanercept

Niclosamide and etanercept

Experimental group

Description:

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

Treatment:

Drug: Niclosamide

Drug: Etanercept