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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- フェーズ2
連絡先と場所
研究連絡先
- 名前：Amira Mashaly
- 電話番号：01028275001
- メール：amashaly@horus.edu.eg
研究場所
-
-
Damietta Governorate
-
Damietta、Damietta Governorate、エジプト
- 募集
- Faculty of Pharmacy, Horus University in Egypt
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Roflumilast
Participants will receive roflumilast in addition to standard disease-modifying antirheumatic drug therapy.
|
Roflumilast administered orally as add-on therapy to standard disease-modifying antirheumatic drugs
|
|
実験的：Desloratadine
Participants will receive desloratadine in addition to standard disease-modifying antirheumatic drug therapy.
|
Desloratadine administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.
|
|
実験的：Placebo
Participants will receive placebo in addition to standard disease-modifying antirheumatic drug therapy.
|
Matching placebo administered orally as add-on therapy to standard disease-modifying antirheumatic drugs.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Disease Activity Score (DAS28)
時間枠：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.
|
Baseline to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in serum inflammatory biomarkers
時間枠：Baseline to 12 weeks
|
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).
|
Baseline to 12 weeks
|
協力者と研究者
スポンサー
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- MDP.26.03.216
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。