Rheumatoid Arthritis, Rheumatoid Arthritis (RA)
Conditions
Keywords
Desloratadine, Rheumatoid arthritis, Add-on therapy, Inflammation, Randomized controlled trial
Brief 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.
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
Desloratadine administered orally as add on therapy to standard disease modifying antirheumatic drugs.
DRUGPlacebo
Matching placebo administered orally as add on therapy to standard disease modifying antirheumatic drugs.
Sponsors
Horus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a double-blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
Intervention model description
Participants are randomly assigned to two parallel groups to receive either Desloratadine or placebo in addition to standard therapy.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity Score (DAS28) | 12 weeks | 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. |
Countries
Egypt
Contacts
CONTACTAmira Mashaly
PRINCIPAL_INVESTIGATORAmira Mashaly
Horus University
Outcome results
None listed