The Clinical Efficacy of Immunomodulators in RA Patients

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

Sponsors

Lead Sponsor: Qilu Hospital of Shandong University

Source Qilu Hospital of Shandong University
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.

Overall Status Recruiting
Start Date 2021-12-22
Completion Date 2026-12-31
Primary Completion Date 2025-06-30
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
The percentage of patients who achieve clinical remission using European League Against Rheumatism (EULAR) response criteria DAS28. week 24
Secondary Outcome
Measure Time Frame
The percentage of patients who achieve clinical remission using DAS28-ESR. week 12
Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders baseline,week 12,week 24
Percentage of participants achieving ACR/EULAR remission week 12,week 24
Change from baseline Simplified Disease Activity Index (SDAI) up to week 24
Change from baseline Clinical Disease Activity Index (CDAI) up to week 24
Change From Baseline in C-reactive Protein (CRP) up to week 24
Change From Baseline in Erythrocyte Sedimentation Rate (ESR) up to week 24
Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI) up to week 24
Percentage of American College of Rheumatology [ACR] 20、 [ACR]50、 [ACR]70 Criteria Responders every time up to week 24
Incidence of participant withdrawal up to week 24
Number of participants with"adverse events (AEs)" up to week 24
Enrollment 400
Condition
Intervention

Intervention Type: Drug

Intervention Name: Iguratimod

Description: 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.

Intervention Type: Drug

Intervention Name: Methotrexate

Description: Methotrexate,10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Other Name: MTX

Intervention Type: Drug

Intervention Name: Adalimumab Injection

Description: 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.

Arm Group Label: Adalimumab+Methotrexate(MTX)

Other Name: adalimu

Intervention Type: Drug

Intervention Name: Leflunomide

Description: Leflunomide,20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Arm Group Label: Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)

Other Name: LEF

Intervention Type: Drug

Intervention Name: Hydroxychloroquine

Description: Hydroxychloroquine,200mg, po, twice per day (bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.

Arm Group Label: Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)

Other Name: HCQ

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Xiaoyun Yang Study Director Qilu Hospital of Shandong University
Overall Contact

Last Name: Qiang Shu, Dr.

Phone: 0086-0531-82169654

Email: [email protected]

Location
Facility: Status: Contact: Qilu Hospital Xiaoyun Yang, Dr. 0086-0531-82169166 [email protected]
Location Countries

China

Verification Date

2022-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Qilu Hospital of Shandong University

Investigator Full Name: Qiang Shu

Investigator Title: Chief Physician

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Methotrexate(MTX)+Iguratimod(IGU)

Type: Experimental

Description: Drug: Iguratimod(IGU),25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Methotrexate(MTX),10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. For RA patients with naive or csDMARDs-IR

Label: Adalimumab+Methotrexate(MTX)

Type: Experimental

Description: Drug: Adalimumab,40mg, iH,q2w, once two weeks (q2w) prescribed at the beginning and adjusted due to patient response. Drug: Methotrexate(MTX),7-10mg, po, quaque week (qw) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR

Label: Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)

Type: Experimental

Description: Drug: Iguratimod(IGU),25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Drug: Leflunomide(LEF),20mg, po, quaque day (qd) prescribed at the beginning and adjusted due to patient response. Drug: Hydroxychloroquine(HCQ),200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. For RA patients with csDMARDs-IR

Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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