Clinical trial NCT05480878: Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis
Official title: Clinical Study Evaluating the Efficacy of Nitazoxanide and Escitalopram as Adjuvant Therapies in Patients With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Nitazoxanide
Escitalopram
STAT3/ JAK2 signaling pathway
TLR-4 /IL -1β signaling pathway
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes from Baseline in Clinical Disease Activity Index (CDAI) Score
timeFrame: Baseline, 12 weeks
measure: Changes in Erythrocyte Sedimentation Rates (ESR)
timeFrame: Baseline, 12 weeks
measure: Changes in C- reactive Protein (CRP)
timeFrame: Baseline,12 weeks
measure: Changes in Rheumatoid factor (RF) values
timeFrame: Baseline,12 weeks
measure: Changes in Anti-cyclic citrullinated peptide (Anti-CCP) values
timeFrame: Baseline,12 weeks
Secondary outcomes:
measure: Determination of Signal transducer and activator of transcription 3 (STAT3) levels
timeFrame: Baseline,12 weeks
measure: Determination of Toll-like receptor4 (TLR-4) levels
timeFrame: Baseline,12 weeks
measure: Determination of interleukin-1β (IL-1β) levels
timeFrame: Baseline, 12 weeks
measure: Determination of Malondialdehyde (MDA) levels
timeFrame: Baseline, 12 weeks
Other outcomes:
measure: Numbers of participants with treatment-related adverse events
timeFrame: Baseline, 12 weeks
Locations:
city: Tanta
country: Egypt
facility: Tanta university
Study officials:
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