The Clinical Efficacy of Immunomodulators in RA Patients

Официальное название

The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China

Обзор

This study includes naive patients and csDMARDs-IR RA patients, treated with different regimens such as Iguratimod combination of different csDMARDs, or csDMARD with TNF inhibitors for 24 weeks. The disease activity and drug response will be observed. The immune disorder and synovial function will be evaluated at the same time.

Подробное описание

In this study cohorts, naïve or csDMARDs-IR patients are treated with different csDMARDs combination or TNF inhibitors for 24 weeks to get remission in clinical. The biomarkers in their plasma and synovial fluid and tissue specimens from RA patients are screened to predict the efficacy of specific treatment.

Вмешательства

• Препарат Iguratimod
  Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
• Препарат Methotrexate
  Methotrexate，10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
• Препарат Adalimumab Injection
  Adalimumab Injection，40mg，iH，every two weeks (q2w) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
• Препарат Leflunomide
  Leflunomide，20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
• Препарат Hydroxychloroquine
  Hydroxychloroquine，200mg, po, twice per day (bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Первичные конечные точки

• The percentage of patients who achieve clinical remission using European League Against Rheumatism (EULAR) response criteria DAS28. [Срок оценки: week 24]

Вторичные конечные точки (11)

• The percentage of patients who achieve clinical remission using DAS28-ESR. [Срок оценки: week 12]
• Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders [Срок оценки: baseline,week 12,week 24]
• Percentage of participants achieving ACR/EULAR remission [Срок оценки: week 12,week 24]
• Change from baseline Simplified Disease Activity Index (SDAI) [Срок оценки: up to week 24]
• Change from baseline Clinical Disease Activity Index (CDAI) [Срок оценки: up to week 24]
• Change From Baseline in C-reactive Protein (CRP) [Срок оценки: up to week 24]
• Change From Baseline in Erythrocyte Sedimentation Rate (ESR) [Срок оценки: up to week 24]
• Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI) [Срок оценки: up to week 24]
• Percentage of American College of Rheumatology [ACR] 20、 [ACR]50、 [ACR]70 Criteria Responders every time [Срок оценки: up to week 24]
• Incidence of participant withdrawal [Срок оценки: up to week 24]
• Number of participants with"adverse events (AEs)" [Срок оценки: up to week 24]

Критерии участия

Критерии включения

\-

1.Patients with RA who meet ACR 1987 rheumatoid arthritis classification criteria or ACR/EULAR 2010 rheumatoid arthritis Classification Criteria and have knee dysfunction.

• ACR 1987 rheumatoid arthritis classification criteria

• morning stiffness lasting at least 1 hour (≥6w)
• there are 3 or more joint areas swollen (≥6w)
• swelling of the wrist, metacarpophalangeal, and proximal phalangeal joint areas (≥6w)
• symmetrical arthrogryposis (≥6w)
• hand x-ray changes (at least osteoporosis and joint space narrowing)
• positive rheumatoid factor (titer > 1:32) RA can be diagnosed by meeting 4 of the above 7 items
• ACR/EULAR 2010 rheumatoid arthritis Classification Criteria

• Involved joints

\- 1 large joint (0 points)

• 2-10 large joints (1 point)
• 1-3 small joints (with or without large joints) (2 points)
• 4-10 small joints (with or without large joints) (3 points)
• more than 10 small joints (at least one small joint) (5 points)
• Serological indicators

• RF and ACPA negative (0 points)
• RF and ACPA, at least one of which is low titer positive. (2 points)
• RF and ACPA with at least one high titer positive (3 points)
• Acute chronotropic reactants

• Both CRP and ESR normal (0 points)
• Abnormal CRP or ESR (1 point)
• Duration of synovitis

• <6 weeks (0 points)
• ≥6 weeks (1 point)

2.Patients with OA who meet the 1995 Classification Criteria for OA and have knee dysfunction 1995 Classification Criteria for Osteoarthritis of the Knee Clinical criteria

a. Knee pain most of the time in the last 1 month b. Bone rubbing sound c, morning stiffness ≤ 30 minutes d, age ≥ 38 years e, with bony enlargement Knee OA can be diagnosed if a+b+c+d or a+b+e is met

3.Age-sex matched healthy volunteers who checked in our hospital.

4.Age > 18 years old;

5.Voluntarily participate in this study and sign an informed consent form

Критерии исключения

• Patients with combined active hepatitis
• Patients with active tuberculosis
• Patients withinfection and malignancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Qilu Hospital — Цзинань

Идентификаторы

NCT: NCT05626348 · Response of DMARDs in RA QiluH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗