Идёт набор NCT07632846

Effect of Roflumilast as Add-On Therapy in Rheumatoid Arthritis

Фаза II С лечением Rheumatoid Arthritis Rheumatoid Arthritis (RA)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Roflumilast 500 Mcg Oral Tablet, Placebo Group.
Кому может быть актуально: Состояния в реестре: Rheumatoid Arthritis, Rheumatoid Arthritis (RA). Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Египет
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Подробное описание

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.

Вмешательства

Препарат Roflumilast 500 Mcg Oral Tablet
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.
Препарат Placebo Group
Matching oral placebo administered as add on therapy to standard disease modifying antirheumatic drug treatment to serve as a comparator for roflumilast.

Первичные конечные точки

Change in Disease Activity Score (DAS28) [Срок оценки: 12 weeks]

Вторичные конечные точки (1)

2. Change in serum inflammatory biomarkers [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

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.