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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desloratadine Group | Experimental | Participants will receive desloratadine 5mg in addition to standard disease modifying antirheumatic drug therapy. |
|
| Placebo Group | Experimental | Participants will receive placebo in addition to standard disease modifying antirheumatic drug therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desloratadine 5 mg | Drug | Desloratadine administered orally as add on therapy to standard disease modifying antirheumatic drugs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amira Mashaly | Contact | 01028275001 | amashaly@horus.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Amira Mashaly | Horus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of medicine, Mansoura University | Recruiting | Al Mansurah | Egypt |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C121345 | desloratadine |
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Participants are randomly assigned to two parallel groups to receive either Desloratadine or placebo in addition to standard therapy.
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This is a double-blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
| Placebo | Drug | Matching placebo administered orally as add on therapy to standard disease modifying antirheumatic drugs. |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |