Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis
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 roflumilast to standard therapy in patients with active rheumatoid arthritis. Participants will receive either roflumilast 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 roflumilast could be a useful add-on treatment option for patients with rheumatoid arthritis.
調査の概要
詳細な説明
rheumatoid arthritis. Roflumilast, a selective phosphodiesterase-4 inhibitor, reduces the production of pro-inflammatory cytokines, This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the efficacy and safety of roflumilast 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 roflumilast, 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
-
-
-
Al Mansurah、エジプト
- 募集
- Faculty of Pharmacy, Horus University in Egypt
-
コンタクト：
- Amira Mashaly
- 電話番号：01028275001
- メール：amashaly@horus.edu.eg
-
-
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.
- Ability to provide written informed consent.
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 Group
|
Roflumilast is an oral phosphodiesterase 4 inhibitor administered as add on therapy to standard disease modifying antirheumatic drug treatment.
It is used to evaluate its potential anti-inflammatory effects on disease activity and inflammatory markers in patients with active rheumatoid arthritis.
他の名前：
|
|
実験的：Placebo Group
|
Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.
|
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：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 roflumilast or placebo.
|
12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
2. Change in serum inflammatory biomarkers
時間枠：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).
|
12 weeks
|
協力者と研究者
スポンサー
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
追加の関連 MeSH 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
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。