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RECRUITING
NCT07566351
PHASE2

Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis

Sponsor: Horus University

View on ClinicalTrials.gov

Summary

Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and disability. Although standard disease-modifying antirheumatic drugs (DMARDs) are effective for many patients, some individuals continue to experience active disease and inflammation. The aim of this study is to evaluate the effectiveness and safety of adding either roflumilast or desloratadine to standard DMARD therapy in patients with rheumatoid arthritis. Participants will be randomly assigned to receive either roflumilast, desloratadine, or placebo in addition to their usual treatment. The study will assess changes in disease activity, inflammatory biomarkers, and patient-reported outcomes over a three-month follow-up period. The results of this study may help identify new add-on treatment options to improve disease control in patients with rheumatoid arthritis.

Official title: Clinical Study to Compare the Possible Efficacy and Safety of Roflumilast and Desloratadine as Adjuvant Therapy for Rheumatoid Arthritis

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-04-23

Completion Date

2027-07

Last Updated

2026-05-12

Healthy Volunteers

No

Interventions

DRUG

Roflumilast

Roflumilast administered orally as add-on therapy to standard disease-modifying antirheumatic drugs

DRUG

Desloratadine

Desloratadine administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.

DRUG

Placebo

Matching placebo administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.

Locations (1)

Faculty of Pharmacy, Horus University in Egypt

Damietta, Damietta Governorate, Egypt