Effect of Roflumilast and Desloratadine as Add-On Therapy in Patients With Rheumatoid Arthritis
Clinical Study to Compare the Possible Efficacy and Safety of Roflumilast and Desloratadine as Adjuvant Therapy for Rheumatoid Arthritis
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 2 단계
연락처 및 위치
연구 연락처
- 이름: Amira Mashaly
- 전화번호: 01028275001
- 이메일: amashaly@horus.edu.eg
연구 장소
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Damietta Governorate
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Damietta, Damietta Governorate, 이집트
- 모병
- Faculty of Pharmacy, Horus University in Egypt
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
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.
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Roflumilast
Participants will receive roflumilast in addition to standard disease-modifying antirheumatic drug therapy.
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Roflumilast administered orally as add-on therapy to standard disease-modifying antirheumatic drugs
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실험적: Desloratadine
Participants will receive desloratadine in addition to standard disease-modifying antirheumatic drug therapy.
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Desloratadine administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.
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실험적: Placebo
Participants will receive placebo in addition to standard disease-modifying antirheumatic drug therapy.
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Matching placebo administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Disease Activity Score (DAS28)
기간: Baseline to 12 weeks
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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.
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Baseline to 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in serum inflammatory biomarkers
기간: Baseline to 12 weeks
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Change in serum levels of inflammatory biomarkers including interleukin-17 (IL-17), monocyte chemoattractant protein-1 (MCP 1), Cyclic adenosine monophosphate (cAMP), and malondialdehyde (MDA).
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Baseline to 12 weeks
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MDP.26.03.216
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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