Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis

Tanta University

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Nitazoxanide 500Mg Oral Tablet; Drug: Escitalopram 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05480878

Rheumatoid Arthritis

Details and patient eligibility

About

This study aims at evaluating the therapeutic effects of both Nitazoxanide and Escitalopram as adjuvant therapies in patients with Rheumatoid Arthritis and to evaluate their impact on STAT3/ JAK2, TLR /IL -1β signaling pathways.

Full description

This study is a randomized, controlled prospective study to evaluate the potential therapeutic effects of the broad -spectrum antimicrobial (Nitazoxanide) and selective serotonin reuptake inhibitor (Escitalopram) on synovial inflammation and angiogenesis when administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients.

A total of 90 RA patients recruited from Outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation at Mansoura University hospitals, Mansoura, Egypt will be included in the study. They will be diagnosed with RA according to the American College of Rheumatology/European League Against Rheumatism criteria 2010 (the ACR/EULAR 2010 criteria).

RA Patients who will meet the inclusion criteria will be enrolled in the study.

They will be classified into three groups:

Group 1: 30 RA patients who will receive the traditional therapy of rheumatoid arthritis for 12 weeks and serve as the control group.

Group 2: 30 RA patients who will receive traditional therapy plus Nitazoxanide 1 gm/day for 12 weeks.

Group 3: 30 RA patients who will receive traditional therapy plus Escitalopram 10 mg/day for 12 weeks.

Clinical Examinations and laboratory parameters will be performed and measured at the beginning of the study and 3 months after randomization to evaluate the efficacy of Nitazoxanide and Escitalopram in the treatment of rheumatoid arthritis.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria.
• Receiving conventional disease modified anti rheumatic drugs (DMARDS).
• Having active disease (the 28-joint disease activity score [DAS28] according to the CRP formula > 2.6).
• Age between 18 and 75 years.
• Conscious and cooperative.
• Male or female.
• Sign an informed consent for the clinical study

Exclusion criteria

1. Pregnant or planning to be pregnant and breast-feeding women.
2. Chronic disease.
3. Other autoimmune diseases, such as systemic lupus erythematosus, Sjogren's syndrome and mixed connective tissue disease.
4. Patients treated with biological TNF-α, IL6 or IL-1β antagonists.
5. Infectious or inflammatory diseases, endocrine disorders, any past or current psychiatric or neurological diseases.
6. Clinically significant hepatic and renal dysfunction or impairment.
7. Alcohol abuse
8. Receiving therapy that interact with Nitazoxanide and Escitalopram.
9. Hypersensitivity to Nitazoxanide and Escitalopram.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Participants in this arm will receive Placebo with the current DMARDs treatments for rheumatoid arthritis for 12 weeks. .

Treatment:

Drug: Placebo

Nitazoxanide

Experimental group

Description:

Participants in this arm will receive Nitazoxanide 1 gm/day + DMARDs for 12 weeks.

Treatment:

Drug: Nitazoxanide 500Mg Oral Tablet

Escitalopram

Experimental group

Description:

Participants in this arm will receive Escitalopram 10 mg/day + DMARDs for 12 weeks.

Treatment:

Drug: Escitalopram 10mg