The Effect of Cilostazol on Rheumatoid Arthritis Patients

NCT05671497 | Completed Phase 2 DMC

• 1 other identifier: ACUC-FP-ASU
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the effect of cilostazol on Rheumatoid Arthritis patients. It aims to answer the questions of :

1. 1.Will Cilostazol improve the disease severity and quality of life in Rheumatoid arthritis patients?
2. 2.Will Cilostazol decrease the oxidative stress, inflammation and endothelial dysfunction in Rheumatoid arthritis patients?

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Cilostazol

Outcome Measures

Primary Outcomes (1)

• Change in the DAS-28 CRP score

  DAS-28 score is used to asses disease severity in Rheumatoid Arthritis. It incorporates the swollen and tender joints present in 28 joints together with the c-reactive protein measurement into an equation to calculate the disease severity. 0.56\* √(TJC28) + 0.28\* √(SJC28) + 0.36\*ln (CRP + 1) +0.014\*(GH) + 0.96 where TJC:is tender joint count SJC is : swollen joint count GH:patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst a number is given which is equal to a specific disease severity. website to calculate the DAS-28 score : https://www.4s-dawn.com/DAS28/

  Baseline, after 3 months , After 6 months

Secondary Outcomes (7)

• Health Assessment Questionnaire

  Baseline, after 3 months , After 6 months

• Total antioxidant capacity (TAC)

  Baseline and at 6 months

• Malondialdehyde (MDA)

  Baseline and at 6 months

• TNF α

  Baseline and at 6 months

• phosphorylated Adenosine monophosphate-activated protein kinase (p-AMPK)

  Baseline and at 6 months

Study Arms (2)

Cilostazol arm

EXPERIMENTAL

35 patients receiving conventional synthetic disease modifying antirheumatic drugs in addition to Cilostazol 100 mg twice daily for 6 months.

Drug: Cilostazol 100 MG; Drug: conventional synthetic antirheumatic drugs

Control

ACTIVE COMPARATOR

35 patients receiving conventional synthetic disease modifying antirheumatic drugs for 6 months.

Drug: conventional synthetic antirheumatic drugs

Interventions

Cilostazol 100 MG DRUG

An antiplatelet agent used for intermittent claudication , it has an anti-inflammatory effect which will help control patients with Rheumatoid arthritis

Cilostazol arm

conventional synthetic antirheumatic drugs DRUG

methotrexate 7.5-15 mg once weekly hydroxychloroquine 200 mg twice daily sulfasalazine 500 mg to 3 g once daily leflunomide 20 mg once daily

Cilostazol arm; Control

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients. (\>18 years old).
• Moderate to high disease activity (DAS28-CRP\>3.2).

You may not qualify if:

• Hypersensitivity to cilostazol.
• Heart failure.
• Pregnant and lactating women.
• Patients with liver impairment (ALT or AST \> 3\* ULN).
• Patients with renal impairment (CrCl\<60 mL/min).
• Patients receiving any other antiplatelet or anticoagulant

Sponsors & Collaborators

• Ain Shams University: lead
• Misr International University: collaborator
• Al-Azhar University: collaborator

Study Sites (1)

Al-Zahraa Hospital

Cairo, Egypt

Location

Related Publications (32)

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MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: December 14, 2022
• First Posted: January 4, 2023
• Study Start: November 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

EG (1)