Effects of Nonsteroidal Anti-Inflammatory Drugs in Recurrence of Spondyloarthritis Patients After Remission

Официальное название

Effects of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) in Recurrence of Spondyloarthritis (SPA) Patients After Remission：A Multicenter, Randomized, Controlled Study

Обзор

The multicenter, randomized controlled trial is to investigate and evaluate the effect of NSAIDs therapy on recurrence in patients with axial spondyloarthritis;

Подробное описание

To investigate the recurrence rate in remission patients who withdraw NSAIDs therapy in axial spondyloarthritis;

Вмешательства

• Препарат To withdraw NSAIDs therapy
  NSAIDs therapy will be withdrew after washout period.
• Препарат To continue NSAIDs therapy
  NSAIDs therapy will be continued.

Первичные конечные точки

• Percentage of participants with Ankylosing Spondylitis Disease Activity Score (ASDAS) active disease [Срок оценки: From Week 0 (baseline) to Week24]

Вторичные конечные точки (12)

• Change in Patient global assessment of disease activity [Срок оценки: From Week 0 (baseline) to Week24]
• Change in total Back Pain [Срок оценки: From Week 0 (baseline) to Week24]
• Change in Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Срок оценки: From Week 0 (baseline) to Week24]
• Change in Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [Срок оценки: From Week 0 (baseline) to Week24]
• Change in Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) [Срок оценки: From Week 0 (baseline) to Week24]
• Change in Short Form-36 Physical Component Summary (SF-36 PCS) [Срок оценки: From Week 0 (baseline) to Week24]
• Change in European Quality of Life-5 Dimensions (EQ-5D) Questionnaire [Срок оценки: From Week 0 (baseline) to Week24]
• Change in Chest Expansion [Срок оценки: From Week 0 (baseline) to Week24]
• Change in Maastricht Ankylosing Spondylitis Enthesitis Index (MASES) [Срок оценки: From Week 0 (baseline) to Week24]
• Change in Number of swelling and tendons affected by enthesitis [Срок оценки: From Week 0 (baseline) to Week24]
• Change in Blood samples: C-reactive protein (CRP) and Erythrocyte sedimentation rate(ESR) [Срок оценки: From Week 0 (baseline) to Week24]
• Observation of relapse time after withdrawal of NSAIDs in remission patients [Срок оценки: From Week 0 (baseline) to Week24]

Критерии участия

Критерии включения

• Capable of giving informed consent and complying with the examination program of the protocol;
• Participants with axial SpA fulfilling the Assessment of Spondyloarthritis international Society 2009 (ASAS) axial SpA classification criteria;
• Participants must fulfill the criteria of maintaining remission of aSpA, defined as ASDAS<1.3；
• Participants must fulfill the criteria of remission of aSpA defined as ASDAS<1.3，then continuous to evaluate every four weeks for three times and ASDAS<1.3 each time.
• Laboratory results must fulfill following requirements: Hb≥85g/L；3.5×109/L≤WBC Count ≤10×109/L；Platelet count ≥ Normal lower limit; Liver function (ALT、TBIL) ≤Twofold of normal upper limit; Renal function (SCr) ≤Normal upper limit;
• The pregnancy test must be negative for women of childbearing age; Efficient contraception must be taken for both male and female participants during the trial period and within three months after the end of the trial.

Критерии исключения

• Participants who previously have experienced allergic reactions to NSAIDs or sulfa-drugs;
• Participants who are intolerant of NSAIDs;
• Participants who are in active axSpA episodes;
• Participants with previous or currant ulcers and/or gastrointestinal conditions or bleeding in three months
• Participants who were in acute infection or acute attack of chronic infection during screening period;
• At the time of screening, participants who were in the acute stage of acute infection or chronic infection, and if the acute infection had improved, they could be re-screened.
• Participants who suffer from invasive fungal infections (e.g. histoplasma, coccidiosis's, candida, aspergillus, blastomyces, pneumocystis, etc.) within the first 6 months of screening; Or opportunistic bacterial infections (e.g. bacterial, viral or other infections, including Legionella and Listeria);
• Participants with other autoimmune diseases which are expected to influence the evaluation of experimental medications, such as inflammatory enteritis, psoriasis, uveitis, etc.
• Participants with previous or currant congestive heart failure, coronary heart disease, serious arrhythmia;
• Participants with severe, progressive, uncontrolled vital organ and systematic disorders, and other conditions that are considered inappropriate to participate in this trial;
• Participants with circumstances that may affect the compliance (e.g. prolonged travel or leave, planned relocation, mental illness, lack of motivation to participate, etc.).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Xiamen University — Xiamen

Публикации

• Zheng Q, Liu W, Huang Y, Gao Z, Wu Y, Wang X, Cai M, He Y, Chen S, Wang B, Liu L, Chen S, Huang H, Zheng L, Kang R, Zeng X, Chen J, Chen H, Chen J, Li Z, Shi G. Predictive Value of Active Sacroiliitis in MRI for Flare Among Chinese Patients with Axial Spondyloarthritis in Remission. Rheumatol Ther. 2021 Mar;8(1):411-424. doi: 10.1007/s40744-021-00279-y. Epub 2021 Feb 18. PMID 33598865

Идентификаторы

NCT: NCT03425812 · 20180101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗