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

NCT07566351 | Recruiting Phase 2

• 1 other identifier: MDP.26.03.216
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis; Roflumilast; Desloratadine; Add-on therapy; double blind Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Change in Disease Activity Score (DAS28)

  Change in disease activity assessed by the Disease Activity Score in 28 joints (DAS28) after 12 weeks of treatment compared with baseline.

  Baseline to 12 weeks

Secondary Outcomes (1)

• Change in serum inflammatory biomarkers

  Baseline to 12 weeks

Study Arms (3)

Roflumilast

EXPERIMENTAL

Participants will receive roflumilast in addition to standard disease-modifying antirheumatic drug therapy.

Drug: Roflumilast

Desloratadine

EXPERIMENTAL

Participants will receive desloratadine in addition to standard disease-modifying antirheumatic drug therapy.

Drug: Desloratadine

Placebo

EXPERIMENTAL

Participants will receive placebo in addition to standard disease-modifying antirheumatic drug therapy.

Drug: Placebo

Interventions

Roflumilast DRUG

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

Roflumilast

Desloratadine DRUG

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

Desloratadine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Faculty of Pharmacy, Horus University in Egypt

Damietta, Damietta Governorate, Egypt

RECRUITING

Related Publications (1)

• Smolen JS, Landewe RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease modifying antirheumatic drugs. Annals of the Rheumatic Diseases. 2020;79(6):685-699.

  BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Roflumilast; desloratadine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Amira Mashaly

CONTACT

01028275001; amashaly@horus.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate, Department of Clinical Pharmacy

Model Details: Participants are randomly assigned to one of three parallel groups to receive roflumilast, desloratadine, or placebo in addition to standard therapy.

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: May 5, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

EG (1)