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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Roflumilast; Drug: Desloratadine; Drug: Placebo

Detailed Description

Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic synovial inflammation, progressive joint destruction, and impaired quality of life. Despite the availability of conventional disease-modifying antirheumatic drugs (DMARDs), a subset of patients continues to have persistent disease activity and inflammatory burden.

Phosphodiesterase-4 inhibitors and antihistamines have demonstrated potential anti-inflammatory and immunomodulatory effects that may be beneficial in rheumatoid arthritis. Roflumilast, a selective phosphodiesterase-4 inhibitor, reduces the production of pro-inflammatory cytokines, while desloratadine has been shown to exhibit additional anti-inflammatory properties beyond its antihistaminic effect.

This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of roflumilast or desloratadine as add-on therapy to standard DMARD treatment in patients with rheumatoid arthritis. Eligible participants will be randomized into three parallel groups to receive either roflumilast, desloratadine, or placebo for a duration of three months.

Clinical assessments will include evaluation of disease activity scores, inflammatory biomarkers, and patient-reported outcomes. Safety and tolerability will be monitored throughout the study period. The findings of this study may provide evidence for novel adjunctive therapeutic strategies in the management of rheumatoid arthritis.

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Amira Mashaly; Phone Number: 01028275001; Email: amashaly@horus.edu.eg

Study Locations

• Egypt
  • Damietta Governorate
    • Damietta, Damietta Governorate, Egypt
      • Recruiting
      • Faculty of Pharmacy, Horus University in Egypt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with active rheumatoid arthritis according to the 2010 American College of Rheumatology and European League Against Rheumatism classification criteria.
• Disease activity score in 28 joints (DAS28) greater than 2.6.
• Age between 18 and 60 years.
• Male and female patients.
• Patients receiving methotrexate in addition to standard conventional therapy.

Exclusion Criteria:

Exclusion Criteria:

• Patients with renal or hepatic disease.
• Known hypersensitivity to the study medications.
• Current use of antioxidant supplements.
• History of psychiatric disorders.
• Use of oral prednisolone at a dose greater than 15 mg per day.
• Current treatment with biological disease modifying antirheumatic drugs.
• Pregnant or breastfeeding patients.
• History of cardiac arrhythmias or prolonged QT interval.
• Use of medications known to prolong the QT interval.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Roflumilast; Participants will receive roflumilast in addition to standard disease-modifying antirheumatic drug therapy.	Drug: Roflumilast; Roflumilast administered orally as add-on therapy to standard disease-modifying antirheumatic drugs
Experimental: Desloratadine; Participants will receive desloratadine in addition to standard disease-modifying antirheumatic drug therapy.	Drug: Desloratadine; Desloratadine administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.
Experimental: Placebo; Participants will receive placebo in addition to standard disease-modifying antirheumatic drug therapy.	Drug: Placebo; Matching placebo administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disease Activity Score (DAS28)	Disease activity will be assessed using the Disease Activity Score in 28 joints (DAS28), which is a composite index ranging from 0 to approximately 9.4. Higher DAS28 scores indicate greater disease activity. The primary outcome is the change in DAS28 score from baseline to 12 weeks.	Baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in serum inflammatory biomarkers	Change in serum levels of inflammatory biomarkers including interleukin-17 (IL-17), monocyte chemoattractant protein-1 (MCP 1), Cyclic adenosine monophosphate (cAMP), and malondialdehyde (MDA).	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Horus University

Publications and helpful links

General Publications

• Smolen JS, Landewe RBM, Bijlsma JWJ, Burmester GR, Dougados M, Kerschbaumer A, McInnes IB, Sepriano A, van Vollenhoven RF, de Wit M, Aletaha D, Aringer M, Askling J, Balsa A, Boers M, den Broeder AA, Buch MH, Buttgereit F, Caporali R, Cardiel MH, De Cock D, Codreanu C, Cutolo M, Edwards CJ, van Eijk-Hustings Y, Emery P, Finckh A, Gossec L, Gottenberg JE, Hetland ML, Huizinga TWJ, Koloumas M, Li Z, Mariette X, Muller-Ladner U, Mysler EF, da Silva JAP, Poor G, Pope JE, Rubbert-Roth A, Ruyssen-Witrand A, Saag KG, Strangfeld A, Takeuchi T, Voshaar M, Westhovens R, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020 Jun;79(6):685-699. doi: 10.1136/annrheumdis-2019-216655. Epub 2020 Jan 22.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: April 29, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis; Roflumilast; Desloratadine; Add-on therapy; double blind Randomized controlled trial
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Roflumilast; desloratadine
• Other Study ID Numbers: MDP.26.03.216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No