NCT05671497

The Effect of Cilostazol on Rheumatoid Arthritis Patients

Evaluation of the Effect of Cilostazol on the Clinical Outcomes of Rheumatoid Arthritis Patients

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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. Will Cilostazol improve the disease severity and quality of life in Rheumatoid arthritis patients? 2. Will Cilostazol decrease the oxidative stress, inflammation and endothelial dysfunction in Rheumatoid arthritis patients? Participants will be randomized into two arms either treatment or control the treatment group will be asked to take Cilostazol 100 mg twice daily in addition to the usual DMARD (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide), while the control group will be taking the usual DMARDs only. Patients in both arms will be followed-up every 2 weeks through out the 6-month duration of the study.

Detailed description

Rheumatoid Arthritis (RA) is an autoimmune disease affecting joints. It usually affects females more. The available treatment aims to slow down disease progression and control the disease symptoms. Treatment is classified into either the conventional DMARDs (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide) or Biological DMARDs such as an Anti-TNF alpha ( Certolizumab, Infliximab , Etanercept or Golimumab) or non-TNF biologics (Rituximab, Abatacept or Tocilizumab). Both classes have their drawbacks. The conventional DMARDs is not effective for many patients and the biological DMARDs have a high cost making their use limited to patients with medical insurance or patients who can afford it, thus making it necessary to find new medications which can improve the outcomes in patients with RA. Cilostazol is an antiplatelet agent used mainly for intermittent Claudication. Recently many preclinical trials have shown efficacy of cilostazol in RA via it's anti-inflammatory action. it also decreases the oxidative stress which is high in ٌRA patients. Patients will be randomized into two arms , one which is treatment and the other is control the treatment group will be asked to take Cilostazol 100 mg twice daily in addition to the usual DMARD (Methotrexate , Sulfasalazine , Hydroxychloroquine or Leflunomide), while the control group will be taking the usual DMARDs only. Patients in both arms will be followed-up every 2 weeks through out the 6-month duration of the study.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Cilostazol 100 MG	An antiplatelet agent used for intermittent claudication , it has an anti-inflammatory effect which will help control patients with Rheumatoid arthritis
DRUG	conventional synthetic antirheumatic drugs	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

Timeline

• Start date: 2022-11-01
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-01-04
• Last updated: 2026-01-02

Locations

1 site across 1 country: Egypt