The Effect of Cilostazol on Rheumatoid Arthritis Patients
NCT ID: NCT05671497
Last Updated: 2026-01-02
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE2/PHASE3
Total Enrollment
70 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-11-01
Study Completion Date
2024-10-01
Brief Summary
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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.
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.
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Detailed Description
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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.
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
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Rheumatoid Arthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Cilostazol arm
35 patients receiving conventional synthetic disease modifying antirheumatic drugs in addition to Cilostazol 100 mg twice daily for 6 months.
Group Type
EXPERIMENTAL
Cilostazol 100 MG
Intervention Type
DRUG
An antiplatelet agent used for intermittent claudication , it has an anti-inflammatory effect which will help control patients with Rheumatoid arthritis
conventional synthetic antirheumatic drugs
Intervention Type
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
Control
35 patients receiving conventional synthetic disease modifying antirheumatic drugs for 6 months.
Group Type
ACTIVE_COMPARATOR
conventional synthetic antirheumatic drugs
Intervention Type
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
Interventions
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Cilostazol 100 MG
An antiplatelet agent used for intermittent claudication , it has an anti-inflammatory effect which will help control patients with Rheumatoid arthritis
Intervention Type
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
Intervention Type
DRUG
Eligibility Criteria
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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.
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
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
Minimum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Misr International University
OTHER
Sponsor Role
collaborator
Al-Azhar University
OTHER
Sponsor Role
collaborator
Ain Shams University
OTHER
Sponsor Role
lead
Responsible Party
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Omar Ashraf Mohamed
Teaching Assistant
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
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Al-Zahraa Hospital
Cairo, , Egypt
Site Status
Countries
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Egypt
References
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Suzuki K, Uchida K, Nakanishi N, Hattori Y. Cilostazol activates AMP-activated protein kinase and restores endothelial function in diabetes. Am J Hypertens. 2008 Apr;21(4):451-7. doi: 10.1038/ajh.2008.6. Epub 2008 Feb 7.
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BACKGROUND
Usenbo A, Kramer V, Young T, Musekiwa A. Prevalence of Arthritis in Africa: A Systematic Review and Meta-Analysis. PLoS One. 2015 Aug 4;10(8):e0133858. doi: 10.1371/journal.pone.0133858. eCollection 2015.
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van Gestel AM, Haagsma CJ, van Riel PL. Validation of rheumatoid arthritis improvement criteria that include simplified joint counts. Arthritis Rheum. 1998 Oct;41(10):1845-50. doi: 10.1002/1529-0131(199810)41:103.0.CO;2-K.
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Charles J, Britt H, Pan Y. Rheumatoid arthritis. Aust Fam Physician. 2013 Nov;42(11):765.
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Yoshida Y, Tanaka T. Interleukin 6 and rheumatoid arthritis. Biomed Res Int. 2014;2014:698313. doi: 10.1155/2014/698313. Epub 2014 Jan 12.
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Castrejon I, Ortiz AM, Toledano E, Castaneda S, Garcia-Vadillo A, Patino E, Gonzalez-Alvaro I. Estimated cutoff points for the 28-joint disease activity score based on C-reactive protein in a longitudinal register of early arthritis. J Rheumatol. 2010 Jul;37(7):1439-43. doi: 10.3899/jrheum.091333. Epub 2010 May 15.
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Das DC, Jahan I, Uddin MG, Hossain MM, Chowdhury MAZ, Fardous Z, Rahman MM, Kabir AKMH, Deb SR, Siddique MAB, Das A. Serum CRP, MDA, Vitamin C, and Trace Elements in Bangladeshi Patients with Rheumatoid Arthritis. Biol Trace Elem Res. 2021 Jan;199(1):76-84. doi: 10.1007/s12011-020-02142-7. Epub 2020 Apr 18.
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Kim HY, Lee SW, Park SY, Baek SH, Lee CW, Hong KW, Kim CD. Efficacy of concurrent administration of cilostazol and methotrexate in rheumatoid arthritis: pharmacologic and clinical significance. Life Sci. 2012 Sep 17;91(7-8):250-7. doi: 10.1016/j.lfs.2012.07.003. Epub 2012 Jul 20.
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Matcham F, Scott IC, Rayner L, Hotopf M, Kingsley GH, Norton S, Scott DL, Steer S. The impact of rheumatoid arthritis on quality-of-life assessed using the SF-36: a systematic review and meta-analysis. Semin Arthritis Rheum. 2014 Oct;44(2):123-30. doi: 10.1016/j.semarthrit.2014.05.001. Epub 2014 May 29.
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El Meidany YM, El Gaafary MM, Ahmed I. Cross-cultural adaptation and validation of an Arabic Health Assessment Questionnaire for use in rheumatoid arthritis patients. Joint Bone Spine. 2003 Jun;70(3):195-202. doi: 10.1016/s1297-319x(03)00004-6.
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Refaie MMM, Ahmed Ibrahim R, Shehata S. Dose dependent effect of cilostazol in induced testicular ischemia reperfusion via modulation of HIF/VEGF and cAMP/SIRT1 pathways. Int Immunopharmacol. 2021 Dec;101(Pt A):108197. doi: 10.1016/j.intimp.2021.108197. Epub 2021 Oct 6.
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Other Identifiers
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ACUC-FP-ASU
Identifier Type: -
Identifier Source: org_study_id
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