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RecruitingNCT07632872Updated Jun 8, 2026

Desloratadine as Adjunct Therapy for Rheumatoid Arthritis

A Phase 2 interventional study of Desloratadine 5 mg and Placebo in Rheumatoid Arthritis (RA) and Rheumatoid Arthritis, sponsored by Horus University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-08.

Sponsored by Horus University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started May 2026; still recruiting 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

Rheumatoid arthritis is a chronic inflammatory disease that causes joint pain, swelling, and reduced physical function. Although standard disease-modifying antirheumatic drugs are effective for many patients, some individuals continue to have active disease.

The purpose of this study is to evaluate the effectiveness and safety of adding desloratadine to standard therapy in patients with active rheumatoid arthritis. Participants will receive either desloratadine or placebo in addition to their usual treatment.

The study will assess changes in disease activity and inflammatory markers over a follow-up period of approximately 12 weeks. The results of this study may help determine whether desloratadine could be a useful add-on treatment option for patients with rheumatoid arthritis.

Read the detailed description

rheumatoid arthritis. 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 desloratadine as add-on therapy to standard DMARD treatment in patients with rheumatoid arthritis. Eligible participants will be randomized into two parallel groups to receive either 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.

02

Conditions studied

  • Rheumatoid Arthritis (RA)
  • Rheumatoid Arthritis

Keywords

  • Desloratadine
  • Rheumatoid arthritis
  • Add-on therapy
  • Inflammation
  • Randomized controlled trial
03

In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's planned enrollment of 60 is below the median of 94 across 1,984 interventional studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Horus University is the lead sponsor of 31 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
  • Ability to provide written informed consent.

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Desloratadine Group

    Participants will receive desloratadine 5mg in addition to standard disease modifying antirheumatic drug therapy.

    Drug: Desloratadine 5 mg

  • Experimental
    Placebo Group

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

    Drug: Placebo

Interventions

  • DrugDesloratadine 5 mg

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

    Also known as: Desloratadine

  • DrugPlacebo

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

06

What researchers measure

Primary outcomes

  1. Change in Disease Activity Score (DAS28)

    Change in disease activity assessed by the Disease Activity Score in 28 joints (DAS28), calculated using tender and swollen joint counts, patient global assessment, and inflammatory markers. DAS28 values are interpreted as follows: remission is defined as a score less than 2.6, low disease activity as 2.6 to 3.2, moderate disease activity as greater than 3.2 to 5.1, and high disease activity as greater than 5.1. The outcome compares DAS28 values at baseline and after 12 weeks of treatment with desloratadine or placebo.

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Faculty of medicine, Mansoura University
    Al Mansurah, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07632872
Lead sponsor
Horus University
Responsible party
Amira Fawzy Mohamed Mashaly (Principal Investigator, Horus University) — Principal investigator
First posted
Jun 8, 2026
Start date
May 23, 2026
Primary completion
Nov 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Jun 8, 2026

Study contacts

Amira Mashaly
Contact
amashaly@horus.edu.eg
01028275001
Amira Mashaly
principal investigator · Horus University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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