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

NCT07566351 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-12

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Horus University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-23
Primary Completion
2027-06-30
Completion
2027-07-31

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07566351 on ClinicalTrials.gov