Clinical trial NCT05671497: The Effect of Cilostazol on Rheumatoid Arthritis Patients
Official title: Evaluation of the Effect of Cilostazol on the Clinical Outcomes of Rheumatoid Arthritis Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Cilostazol
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Misr International University
name: Al-Azhar University
First posted: 2023-01-04
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the DAS-28 CRP score
timeFrame: Baseline, after 3 months , After 6 months
Secondary outcomes:
measure: Health Assessment Questionnaire
timeFrame: Baseline, after 3 months , After 6 months
measure: Total antioxidant capacity (TAC)
timeFrame: Baseline and at 6 months
measure: Malondialdehyde (MDA)
timeFrame: Baseline and at 6 months
measure: TNF α
timeFrame: Baseline and at 6 months
measure: phosphorylated Adenosine monophosphate-activated protein kinase (p-AMPK)
timeFrame: Baseline and at 6 months
measure: Vascular cell adhesion protein 1(VCAM-1)
timeFrame: baseline and at 6 months
measure: Cilostazol safety
timeFrame: From date of randomization then every two weeks up to 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al-Zahraa Hospital
Study officials:
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