Clinical Study to Compare the Possible Efficacy and Safety of Roflumilast and Desloratadine as Adjuvant Therapy for Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Disease Activity Score (DAS28)
研究概览
简要总结
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.
详细描述
Rheumatoid arthritis (RA) is a systemic autoimmune disease characterized by chronic synovial inflammation, progressive joint destruction, and impaired quality of life. Despite the availability of conventional disease-modifying antirheumatic drugs (DMARDs), a subset of patients continues to have persistent disease activity and inflammatory burden.
Phosphodiesterase-4 inhibitors and antihistamines have demonstrated potential anti-inflammatory and immunomodulatory effects that may be beneficial in rheumatoid arthritis. Roflumilast, a selective phosphodiesterase-4 inhibitor, reduces the production of pro-inflammatory cytokines, while 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 roflumilast or desloratadine as add-on therapy to standard DMARD treatment in patients with rheumatoid arthritis. Eligible participants will be randomized into three parallel groups to receive either roflumilast, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study in which participants, care providers, investigators, and outcome assessors are blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Age between 18 and 60 years.
- •Male and female patients.
- •Patients receiving methotrexate in addition to standard conventional therapy.
排除标准
- •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.
研究组 & 干预措施
Placebo
Participants will receive placebo in addition to standard disease-modifying antirheumatic drug therapy.
干预措施: Placebo (Drug)
Roflumilast
Participants will receive roflumilast in addition to standard disease-modifying antirheumatic drug therapy.
干预措施: Roflumilast (Drug)
Desloratadine
Participants will receive desloratadine in addition to standard disease-modifying antirheumatic drug therapy.
干预措施: Desloratadine (Drug)
结局指标
主要结局
Change in Disease Activity Score (DAS28)
时间窗: Baseline to 12 weeks
Disease activity will be assessed using the Disease Activity Score in 28 joints (DAS28), which is a composite index ranging from 0 to approximately 9.4. Higher DAS28 scores indicate greater disease activity. The primary outcome is the change in DAS28 score from baseline to 12 weeks.
次要结局
未报告次要终点
研究者
Amira Fawzy Mohamed Mashaly
Principal Investigator
Horus University