Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05626348 | RECRUITING | Arthritis, Rheumatoid

The Clinical Efficacy of Immunomodulators in RA Patients
Sponsor:

Qilu Hospital of Shandong University

Information provided by (Responsible Party):

Q i Ang Shu

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.

Condition or disease

Arthritis, Rheumatoid

Intervention/treatment

Iguratimod

Methotrexate

Adalimumab Injection

Leflunomide

Hydroxychloroquine

Phase

PHASE4

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 400 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : The Clinical Study to Observe the Efficacy and Safety of Immunomodulators in Rheumatoid Arthritis Patients for 6 Months Treatment in China
Actual Study Start Date : 2021-12-22
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2026-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • -
  • 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
The Clinical Efficacy of Immunomodulators in RA Patients

Location Details

NCT05626348

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Shandong

Q i road hospital

women, Shandong, China, 250012