Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis

April 22, 2023 updated by: Abeer Abdelmhsen Elsayed Elmotwally, Tanta University

Clinical Study Evaluating the Efficacy of Nitazoxanide and Escitalopram as Adjuvant Therapies 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Tanta, Egypt
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control

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

.
Drug: Placebo
Placebo will be administered to the control group for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Experimental: Nitazoxanide
Participants in this arm will receive Nitazoxanide 1 gm/day + DMARDs for 12 weeks.
Drug: Nitazoxanide 500Mg Oral Tablet
All subjects will receive Nitazoxanide 500gm twice daily for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
Experimental: Escitalopram
Participants in this arm will receive Escitalopram 10 mg/day + DMARDs for 12 weeks.
Drug: Escitalopram 10mg
All subjects will receive Escitalopram 10 mg/day for 12 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 weeks
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.
Baseline, 12 weeks
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.
Baseline,12 weeks
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.
Baseline,12 weeks
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.
Baseline,12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline,12 weeks
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.
Baseline,12 weeks
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.
Baseline, 12 weeks
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
Baseline, 12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2022

Primary Completion (Actual)

March 25, 2023

Study Completion (Actual)

April 1, 2023

Study Registration Dates

First Submitted

July 23, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 22, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rheumatoid Arthritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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