Cilostazol and Methotrexate in Rheumatoid Arthritis

Tanta University

Status and phase: Enrolling; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Cilostazol; Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT05594680

cilostazol in rheumatoid

Details and patient eligibility

About

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).

Full description

Rheumatoid arthritis (RA) is characterized by the presence of hyperplastic synovium in association with immune-mediated inflammatory synovitis associated with chronic production of proinflammatory cytokines, which lead to cartilage and bone degradation .This study is a randomized, controlled double blind placebo-controlled ,prospective study to evaluate the potential therapeutic effects of Cilostazol on synovial inflammation when administered as add-on treatments to the low dose of Methotrexate.

A total of 70 RA patients with active disease will be recruited from Outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation at Mansoura University hospitals, Mansoura, Egypt will be included in the study. They will be diagnosed with RA according to the American College of Rheumatology/European League Against Rheumatism criteria 2010 (the ACR/EULAR 2010 criteria).

RA Patients who will meet the inclusion criteria will be enrolled in the study.

They will be classified into two groups:

Group 1: 35 RA patients who will receive Methotrexate and placebo for 12 weeks and serve as the control group.

Group 2: 35 RA patients who will receive Methotrexate and Cilostazol 50 mg twice daily for 12 weeks.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Cilostazol and Methotrexate

Active Comparator group

Description:

Participants in this arm will receive Cilostazol 50 mg twice daily with Methotrexate for rheumatoid arthritis for 12 weeks.

Treatment:

Drug: Cilostazol

Drug: Methotrexate

Placebo and Methotrexate

Placebo Comparator group

Description:

Participants in this arm will receive Placebo with Methotrexate for rheumatoid arthritis for 12 weeks.

Treatment:

Drug: Placebo

Drug: Methotrexate