The Effect of Cilostazol on Rheumatoid Arthritis Patients

Ain Shams University

Status and phase: Active, not recruiting; Phase 3; Phase 2

Conditions: Rheumatoid Arthritis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05671497

ACUC-FP-ASU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult patients. (>18 years old).
2. Moderate to high disease activity (DAS28-CRP>3.2).
3. Patients receiving stable cDMARD regimen for at least 3 months before inclusion in the study.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Cilostazol arm

Experimental group

Description:

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

Treatment:

Drug: Cilostazol 100 MG

Drug: conventional synthetic antirheumatic drugs

Control

Active Comparator group

Description:

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

Treatment:

Drug: conventional synthetic antirheumatic drugs