Cilostazol combined with Methotrexate for treating Rheumatoid Arthritis
The Phosphodiesterase 3 Inhibitor Cilostazol as Adjunct to Methotrexate in Patients With Rheumatoid Arthritis
This study is testing if adding Cilostazol to low-dose Methotrexate can help people with active Rheumatoid Arthritis feel better over 12 weeks.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Mansoura) |
| Trial ID | NCT05594680 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effects of Cilostazol as an additional treatment to low-dose Methotrexate in patients with active Rheumatoid Arthritis. It is a randomized, controlled, double-blind, placebo-controlled trial involving 70 patients who will be divided into two groups: one receiving Methotrexate and placebo, and the other receiving Methotrexate and Cilostazol for 12 weeks. The study aims to assess the impact of Cilostazol on synovial inflammation and related biomarkers. Participants will be recruited from the outpatient clinic at Mansoura University hospitals in Egypt.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 60 with active Rheumatoid Arthritis not in remission.
Not a fit: Patients with diabetes, heart disease, severe anemia, or other inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve the management of Rheumatoid Arthritis and reduce inflammation in patients.
How similar studies have performed: While this approach is novel in the context of combining Cilostazol with Methotrexate, similar studies have shown promise in using adjunct therapies for Rheumatoid Arthritis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) 2010 criteria (13) i.e 28 joints disease activity score (DAS-28) \>2.6. * Age range between 18 and 60 years old. * Patients receive methotrexate; approximately the same doses of non steroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids (Prednisolone \< 15 mg) will be allowed to enroll the trial. * Intravenous, intra-articular or intramuscular corticosteroids; intra articular hyaluronate sodium; biological DMARDs and other conventional DMARDs will not be permitted less than 4 weeks before the first dose of cilostazol. Exclusion Criteria: * Patients with diabetes, congestive heart failure, other heart disease (arrhythmia, hypertension, ischemic heart diseases), severe anemia, bleeding problems, other inflammatory diseases, active infection, other illness except rheumatoid arthritis. * Patients on low doses of aspirin * Patients on anticoagulants. * Patients with renal or hepatic diseases. * Patients receiving oral prednisolone greater than 15 mg/day. * Patients receiving biological DMARDs. * Patients with hypersensitivity to study medications. * Patients using antioxidants . * Pregnant and lactating females.
Where this trial is running
Mansoura
- Faculty of medicine — Mansoura, Egypt (Recruiting)
Study contacts
- Study coordinator: Samar Mahmoud Eldadamouny, Pharmacist
- Email: samer.abdelfattah99@gmail.com
- Phone: +201008456735
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.