The Phosphodiesterase 3 Inhibitor Cilostazol as Adjunct to Methotrexate in Patients With Rheumatoid Arthritis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study aims at evaluating the therapeutic effects of Cilostazol as adjuvant therapies to low dose of Methotrexate in patients with Rheumatoid Arthritis and to evaluate their impact on Cyclic adenosine monophosphate(CAMP), Heme Oxygenase-1(HO-1).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Egypt
Faculty of medicine
RECRUITING
Al Mansurah
Contact Information
Primary
Samar Mahmoud Eldadamouny, Pharmacist
samer.abdelfattah99@gmail.com
+201008456735
Backup
Tarek Mohamed Mostafa, Professor
tarek.mostafa@pharm.tanta.edu.eg
+201154594035
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2024-11-01
Participants
Target number of participants: 70
Treatments
Active_comparator: Cilostazol and Methotrexate
Participants in this arm will receive Cilostazol 50 mg twice daily with Methotrexate for rheumatoid arthritis for 12 weeks.
Placebo_comparator: Placebo and Methotrexate
Participants in this arm will receive Placebo with Methotrexate for rheumatoid arthritis for 12 weeks.
Related Therapeutic Areas
Rheumatoid Arthritis (RA)
Arthritis
Sponsors
Leads: Tanta University

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

Efficacy and Safety of Resveratrol in Patients With Rheumatoid Arthritis.

Enrollment Status: Recruiting
Publish Date: July 28, 2025
Intervention Type: Dietary supplement, Drug
Study Phase: Not Applicable

Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.

Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.

Who is this study for: Child to young adult patients with Juvenile Idiopathic Arthritis
Enrollment Status: Recruiting
Publish Date: October 09, 2025
Intervention Type: Drug
Study Drug: Baricitinib
Study Phase: Phase 3

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Phase 2a Clinical Trial to Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients Following 26 Weeks of Oral Treatment

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Groups, Phase 2a Clinical Trial to Explore the Efficacy and Evaluate the Safety of Vutiglabridin in Knee Osteoarthritis Patients Following 26 Weeks of Oral Treatment

Enrollment Status: Recruiting
Publish Date: August 15, 2025
Intervention Type: Drug
Study Phase: Phase 2
View All