Rheumatoid ArthritisPhase 2/3NCT05671497
The Effect of Cilostazol on Rheumatoid Arthritis Patients
A Phase 2/3 study testing Cilostazol 100 MG and conventional synthetic antirheumatic drugs in people with Rheumatoid Arthritis, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Cilostazol 100 MG and conventional synthetic antirheumatic drugs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 1 Oct 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients. (>18 years old).
- Moderate to high disease activity (DAS28-CRP>3.2).
- Patients receiving stable cDMARD regimen for at least 3 months before inclusion in the study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Cilostazol on the Clinical Outcomes of Rheumatoid Arthritis Patients
The goal of this study is to evaluate the effect of cilostazol on Rheumatoid Arthritis patients. It aims to answer the questions of :
- Will Cilostazol improve the disease severity and quality of life in Rheumatoid arthritis patients?
- Will Cilostazol decrease the oxidative stress, inflammation and endothelial dysfunction in Rheumatoid arthritis patients?
Read more
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.
Read the 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
- Being tested
- Cilostazol 100 MG, conventional synthetic antirheumatic drugs
- Keywords
- Rheumatoid Arthritis, Cilostazol
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cilostazol 100 MGDrug
An antiplatelet agent used for intermittent claudication , it has an anti-inflammatory effect which will help control patients with Rheumatoid arthritis
conventional synthetic antirheumatic drugsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Cilostazol arm | Experimental | 35 patients receiving conventional synthetic disease modifying antirheumatic drugs in addition to Cilostazol 100 mg twice daily for 6 months. Receives: Drug: Cilostazol 100 MG; Drug: conventional synthetic antirheumatic drugs |
| Control | Active comparator | 35 patients receiving conventional synthetic disease modifying antirheumatic drugs for 6 months. Receives: Drug: conventional synthetic antirheumatic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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/
Measured: Baseline, after 3 months , After 6 months
Secondary outcomes (7)
Health Assessment Questionnaire
Rheumatoid arthritis health assessment questionnaire is a self-administered questionnaire help assess patients' functional status. Health assessment questionnaire is validated and present in Arabic language to be administered to Egyptian patients.
There are 8 categories in the HAQ assessing the daily activities. In each category the highest score is taken. There are 2 to 3 questions in each category with a scale from 0 to 3 where 0 means no functional limitation and 3 means unable to do this activity. If the patient is using an assistive device the minimum score for this category should be 2. At the end the patient category score is added and divided by 8. The final score is given from 0 to 3 where 3 indicates a poor quality of life.
Measured: Baseline, after 3 months , After 6 months
Total antioxidant capacity (TAC)
Oxidative stress is linked to the pathogenesis of various diseases including RA, cilostazol was shown to decrease the oxidative stress in other disease. so measuring the total antioxidant capacity in order to show the oxidative stress levels.
Measured: Baseline and at 6 months
Malondialdehyde (MDA)
Malondialdehyde is a reactive oxygen species molecule. the level of MDA reflect the oxidative stress present which is important for the pathogenesis of various diseases including Rheumatoid arthritis
Measured: Baseline and at 6 months
TNF α
TNF-alpha is a pro-inflammatory marker used to detect degree of inflammation , and as Rheumatoid arthritis is an inflammatory disease , TNF-alpha measurement would give an insight to RA inflammatory state. TNF-alpha is
Measured: Baseline and at 6 months
phosphorylated Adenosine monophosphate-activated protein kinase (p-AMPK)
p-AMPK is an important marker of inflammatory response as it inhibits inflammatory pathway, measuring p-AMPK would give an insight on the inflammatory response present in Rheumatoid arthritis
Measured: Baseline and at 6 months
Vascular cell adhesion protein 1(VCAM-1)
ilostazol was reported to improve the endothelial dysfunction associated with diabetes in diabetic rats through decreasing the adhesion molecules, such as VCAM-1 by an AMPK dependent action which could be beneficial in RA associated endothelial dysfunction
Measured: baseline and at 6 months
Cilostazol safety
Cilostazol safety will be monitored by asking patients through monthly visits and using phone calls every 2 weeks about occurrence of any side effects. The expected side effects of cilostazol are; headache, diarrhea and nausea and stomach pain. Some serious side effects can occur such as bruising , bleeding , palpations and swelling of the arms, hands, feet, ankles, or lower legs
Measured: From date of randomization then every two weeks up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Nov 2022
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Misr International University, Al-Azhar University
- Responsible party
- Principal investigator, Omar Ashraf Mohamed, Misr International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05671497
- Sponsor's protocol ID
- ACUC-FP-ASU
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2022
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Almutairi K, Nossent J, Preen D, Keen H, Inderjeeth C. The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatol Int. 2021 May;41(5):863-877. doi: 10.1007/s00296-020-04731-0. Epub 2020 Nov 11.
PubMed 33175207Castrejon 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.
PubMed 20472931Cha Y, Erez T, Reynolds IJ, Kumar D, Ross J, Koytiger G, Kusko R, Zeskind B, Risso S, Kagan E, Papapetropoulos S, Grossman I, Laifenfeld D. Drug repurposing from the perspective of pharmaceutical companies. Br J Pharmacol. 2018 Jan;175(2):168-180. doi: 10.1111/bph.13798. Epub 2017 May 18.
PubMed 28369768Conigliaro P, Triggianese P, De Martino E, Fonti GL, Chimenti MS, Sunzini F, Viola A, Canofari C, Perricone R. Challenges in the treatment of Rheumatoid Arthritis. Autoimmun Rev. 2019 Jul;18(7):706-713. doi: 10.1016/j.autrev.2019.05.007. Epub 2019 May 3.
PubMed 31059844da Motta NA, de Brito FC. Cilostazol exerts antiplatelet and anti-inflammatory effects through AMPK activation and NF-kB inhibition on hypercholesterolemic rats. Fundam Clin Pharmacol. 2016 Aug;30(4):327-37. doi: 10.1111/fcp.12195. Epub 2016 Mar 31.
PubMed 26950185Das 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.
PubMed 32306287Ferro F, Elefante E, Luciano N, Talarico R, Todoerti M. One year in review 2017: novelties in the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2017 Sep-Oct;35(5):721-734. Epub 2017 Sep 13.
PubMed 28956527Foster W, Carruthers D, Lip GY, Blann AD. Inflammatory cytokines, endothelial markers and adhesion molecules in rheumatoid arthritis: effect of intensive anti-inflammatory treatment. J Thromb Thrombolysis. 2010 May;29(4):437-42. doi: 10.1007/s11239-009-0370-y.
PubMed 19578810Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137-45. doi: 10.1002/art.1780230202.
PubMed 7362664Gaffo A, Saag KG, Curtis JR. Treatment of rheumatoid arthritis. Am J Health Syst Pharm. 2006 Dec 15;63(24):2451-65. doi: 10.2146/ajhp050514.
PubMed 17158693Garcia-Gonzalez A, Gaxiola-Robles R, Zenteno-Savin T. Oxidative stress in patients with rheumatoid arthritis. Rev Invest Clin. 2015 Jan-Feb;67(1):46-53.
PubMed 25857584Kim 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.
PubMed 22820172Lee YS, Lee SY, Park SY, Lee SW, Hong KW, Kim CD. Cilostazol add-on therapy for celecoxib synergistically inhibits proinflammatory cytokines by activating IL-10 and SOCS3 in the synovial fibroblasts of patients with rheumatoid arthritis. Inflammopharmacology. 2019 Dec;27(6):1205-1216. doi: 10.1007/s10787-019-00605-5. Epub 2019 May 23.
PubMed 31123968Lin YJ, Anzaghe M, Schulke S. Update on the Pathomechanism, Diagnosis, and Treatment Options for Rheumatoid Arthritis. Cells. 2020 Apr 3;9(4):880. doi: 10.3390/cells9040880.
PubMed 32260219Liu T, Zhang L, Joo D, Sun SC. NF-kappaB signaling in inflammation. Signal Transduct Target Ther. 2017;2:17023-. doi: 10.1038/sigtrans.2017.23. Epub 2017 Jul 14.
PubMed 29158945
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cilostazol on the Clinical Outcomes of Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05671497
- Acronym / sponsor ID
- ACUC-FP-ASU
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Cilostazol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Misr International University, Al-Azhar University
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to evaluate the effect of cilostazol on Rheumatoid Arthritis patients. It aims to answer the questions of :
- Will Cilostazol improve the disease severity and quality of life in Rheumatoid arthritis patients?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cilostazol arm | Experimental | Drug: Cilostazol 100 MG, Drug: conventional synthetic antirheumatic drugs35 patients receiving conventional synthetic disease modifying antirheumatic drugs in addition to Cilostazol 100 mg twice daily for 6 months. |
| Control | Active comparator | Drug: conventional synthetic antirheumatic drugs35 patients receiving conventional synthetic disease modifying antirheumatic drugs for 6 months. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients. (>18 years old).
- Moderate to high disease activity (DAS28-CRP>3.2).
- Patients receiving stable cDMARD regimen for at least 3 months before inclusion in the study.
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cilostazol 100 MGAn antiplatelet agent used for intermittent claudication , it has an anti-inflammatory effect which will help control patients with Rheumatoid arthritis | Drug | Cilostazol arm |
| conventional synthetic antirheumatic drugsmethotrexate 7.5-15 mg once weekly hydroxychloroquine 200 mg twice daily sulfasalazine 500 mg to 3 g once daily leflunomide 20 mg once daily | Drug | Cilostazol arm, Control |
Primary outcome
Change in the DAS-28 CRP score
Time frame: Baseline, after 3 months , After 6 months
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/
7 secondary outcomes
Health Assessment Questionnaire
Time frame: Baseline, after 3 months , After 6 months
Total antioxidant capacity (TAC)
Time frame: Baseline and at 6 months
Malondialdehyde (MDA)
Time frame: Baseline and at 6 months
TNF α
Time frame: Baseline and at 6 months
phosphorylated Adenosine monophosphate-activated protein kinase (p-AMPK)
Time frame: Baseline and at 6 months
Vascular cell adhesion protein 1(VCAM-1)
Time frame: baseline and at 6 months
Cilostazol safety
Time frame: From date of randomization then every two weeks up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Background: PubMed 33175207Almutairi K, Nossent J, Preen D, Keen H, Inderjeeth C. The global prevalence of rheumatoid arthritis: a meta-analysis based on a systematic review. Rheumatol Int. 2021 May;41(5):863-877. doi: 10.1007/s00296-020-04731-0. Epub 2020 Nov 11.
- Background: PubMed 20472931Castrejon 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.
- Background: PubMed 28369768Cha Y, Erez T, Reynolds IJ, Kumar D, Ross J, Koytiger G, Kusko R, Zeskind B, Risso S, Kagan E, Papapetropoulos S, Grossman I, Laifenfeld D. Drug repurposing from the perspective of pharmaceutical companies. Br J Pharmacol. 2018 Jan;175(2):168-180. doi: 10.1111/bph.13798. Epub 2017 May 18.
- Background: PubMed 31059844Conigliaro P, Triggianese P, De Martino E, Fonti GL, Chimenti MS, Sunzini F, Viola A, Canofari C, Perricone R. Challenges in the treatment of Rheumatoid Arthritis. Autoimmun Rev. 2019 Jul;18(7):706-713. doi: 10.1016/j.autrev.2019.05.007. Epub 2019 May 3.
- Background: PubMed 26950185da Motta NA, de Brito FC. Cilostazol exerts antiplatelet and anti-inflammatory effects through AMPK activation and NF-kB inhibition on hypercholesterolemic rats. Fundam Clin Pharmacol. 2016 Aug;30(4):327-37. doi: 10.1111/fcp.12195. Epub 2016 Mar 31.
- Background: PubMed 32306287Das 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.
- Background: PubMed 28956527Ferro F, Elefante E, Luciano N, Talarico R, Todoerti M. One year in review 2017: novelties in the treatment of rheumatoid arthritis. Clin Exp Rheumatol. 2017 Sep-Oct;35(5):721-734. Epub 2017 Sep 13.
- Background: PubMed 19578810Foster W, Carruthers D, Lip GY, Blann AD. Inflammatory cytokines, endothelial markers and adhesion molecules in rheumatoid arthritis: effect of intensive anti-inflammatory treatment. J Thromb Thrombolysis. 2010 May;29(4):437-42. doi: 10.1007/s11239-009-0370-y.
- Background: PubMed 7362664Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980 Feb;23(2):137-45. doi: 10.1002/art.1780230202.
- Background: PubMed 17158693Gaffo A, Saag KG, Curtis JR. Treatment of rheumatoid arthritis. Am J Health Syst Pharm. 2006 Dec 15;63(24):2451-65. doi: 10.2146/ajhp050514.
- Background: PubMed 25857584Garcia-Gonzalez A, Gaxiola-Robles R, Zenteno-Savin T. Oxidative stress in patients with rheumatoid arthritis. Rev Invest Clin. 2015 Jan-Feb;67(1):46-53.
- Background: PubMed 22820172Kim 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Cilostazol 100 MG and conventional synthetic antirheumatic drugs in people with Rheumatoid Arthritis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the DAS-28 CRP score (time frame: Baseline, after 3 months , After 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05671497, which also lists 32 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.