Desloratadine as Adjunct Therapy for Rheumatoid Arthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Desloratadine 5 mg, Placebo.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis (RA), Rheumatoid Arthritis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effect of Desloratadine as Add-On Therapy in Rheumatoid Arthritis
Overview
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.
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.
Interventions
- Drug Desloratadine 5 mg
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.
Primary outcome measures
- Change in Disease Activity Score (DAS28) [Time frame: 12 weeks]
Eligibility criteria
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Faculty of medicine, Mansoura University — Al Mansurah
Identifiers
NCT: NCT07632872 · MDP.26.03.227