Clinical trial NCT05626348: The Clinical Efficacy of Immunomodulators in RA Patients
Official title: The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: csDMARDs
TNFi
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

1. ACR 1987 rheumatoid arthritis classification criteria

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

   1. 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)
   2. 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)
   3. Acute chronotropic reactants

      * Both CRP and ESR normal (0 points)
      * Abnormal CRP or ESR (1 point)
   4. 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

Exclusion Criteria:

1. Patients with combined active hepatitis
2. Patients with active tuberculosis
3. Patients withinfection and malignancy

Primary outcomes:
measure: The percentage of patients who achieve clinical remission using European League Against Rheumatism (EULAR) response criteria DAS28.
timeFrame: week 24
Secondary outcomes:
measure: The percentage of patients who achieve clinical remission using DAS28-ESR.
timeFrame: week 12
measure: Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders
timeFrame: baseline,week 12,week 24
measure: Percentage of participants achieving ACR/EULAR remission
timeFrame: week 12,week 24
measure: Change from baseline Simplified Disease Activity Index (SDAI)
timeFrame: up to week 24
measure: Change from baseline Clinical Disease Activity Index (CDAI)
timeFrame: up to week 24
measure: Change From Baseline in C-reactive Protein (CRP)
timeFrame: up to week 24
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: up to week 24
measure: Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)
timeFrame: up to week 24
measure: Percentage of American College of Rheumatology [ACR] 20、 [ACR]50、 [ACR]70 Criteria Responders every time
timeFrame: up to week 24
measure: Incidence of participant withdrawal
timeFrame: up to week 24
measure: Number of participants with"adverse events (AEs)"
timeFrame: up to week 24
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiaoyun Yang
role: STUDY_DIRECTOR
References: