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NCT Number: NCT05480878

Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis 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–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Tanta university

Tanta, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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

Treatment and study plan

Placebo

Drug

Placebo will be administered to the control group for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.

Nitazoxanide 500Mg Oral Tablet

Drug

All subjects will receive Nitazoxanide 500gm twice daily for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.

Escitalopram 10mg

Drug

All subjects will receive Escitalopram 10 mg/day for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.

Primary outcomes

  1. Changes from Baseline in Clinical Disease Activity Index (CDAI) Score

    Time frame: Baseline, 12 weeks

    To evaluate the effect of the use of Nitazoxanide and Escitalopram as an add-on therapy in patients with rheumatoid arthritis by evaluating the change from baseline in the clinical findings as measured by Clinical Disease Activity Index (CDAI) scores. A lower CDAI score from Baseline would mean improvement in disease activity and an increase in CDAI score from Baseline would mean an increase in disease activity or a worsening in disease activity. Scores: 0.0-2.8 = Range for Remission; 2.9-10.0 = Range for Low disease activity; 10.1-22.0 Range for Moderate disease activity; 22.1-76 Range for High disease activity. Total range is from 0-100, with the high scores representing high disease activity.

  2. Changes in Erythrocyte Sedimentation Rates (ESR)

    Time frame: Baseline, 12 weeks

    Erythrocyte Sedimentation Rates (ESR) values will be made at baseline and after 12 weeks to determine the number of patients whose test result improved or worsened. ESR (normal range 0-28 mm/hr). If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.

  3. Changes in C- reactive Protein (CRP)

    Time frame: Baseline,12 weeks

    C- reactive Protein (CRP) values will be made at baseline and after 12 weeks to determine the number of patients whose test result improved or worsened. CRP value (normal range <1.0 mg/dl). If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.

  4. Changes in Rheumatoid factor (RF) values

    Time frame: Baseline,12 weeks

    Rheumatoid factor (RF) values will be made at baseline and after 12 weeks to determine the number of patients whose test result improved or worsened. If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.

  5. Changes in Anti-cyclic citrullinated peptide (Anti-CCP) values

    Time frame: Baseline,12 weeks

    Anti-cyclic citrullinated peptide (Anti-CCP) values will be made at baseline and after 12 weeks to determine the number of patients whose test result improved or worsened. If the value is increased, the disease activity worsened. If the value is reduced the disease activity is improved.

Secondary outcomes

  1. Determination of Signal transducer and activator of transcription 3 (STAT3) levels

    Time frame: Baseline,12 weeks

    Serum STAT3 levels will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturers protocol

  2. Determination of Toll-like receptor4 (TLR-4) levels

    Time frame: Baseline,12 weeks

    Serum TLR4 levels will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturers protocol.

  3. Determination of interleukin-1β (IL-1β) levels

    Time frame: Baseline, 12 weeks

    Serum IL-1β levels will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturers protocol.

  4. Determination of Malondialdehyde (MDA) levels

    Time frame: Baseline, 12 weeks

    Serum MDA levels will be measured by means of the human enzyme-linked immunosorbent assay (ELISA) technique according to the manufacturers protocol

Other outcomes

  1. Numbers of participants with treatment-related adverse events

    Time frame: Baseline, 12 weeks

    The adverse events in each group will be observed and documented during the whole procedure to show the safety of the treatment.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Clinical Study Evaluating the Efficacy of Nitazoxanide and Escitalopram as Adjuvant Therapies in Patients With Rheumatoid Arthritis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Apr 25, 2023

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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