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The Clinical Efficacy of Immunomodulators in RA Patients

ConditionArthritis, Rheumatoid
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorQilu Hospital of Shandong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Patients with combined active hepatitis

Patients with active tuberculosis

Patients withinfection and malignancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iguratimod

    Drug

    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.

  • Methotrexate

    Drug

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

  • Adalimumab Injection

    Drug

    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.

  • Leflunomide

    Drug

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

  • Hydroxychloroquine

    Drug

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

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: Methotrexate(MTX)+Iguratimod(IGU)Experimental treatment 2 interventions
Group B: Adalimumab+Methotrexate(MTX)Experimental treatment 2 interventions
Group C: Iguratimod(IGU)+Leflunomide(LEF)+Hydroxychloroquine(HCQ)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

The percentage of patients who achieve clinical remission using European League Against Rheumatism (EULAR) response criteria DAS28.

The percentage of patients whose Disease Activity Score in 28 Joints (DAS28) achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2). The DAS28 is a composite score derived from 4 of these measures，that is the count of tender joint count（TJC, 0-28）and swollen joint count（SJC, 0-28）, measure erythrocyte sedimentation rate (ESR, mm/h) or C reactive protein (CRP, mg/L) and to make a patient assessment of disease activity i.e. 'global assessment of health' (GH) using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst. DAS28 values were calculated as follows: DAS28- ESR = 0.56√(TJC) + 0.28√(SJC) + 0.70 ln ESR + 0.014 x GH. High disease activity: DAS28-ESR \> 5.1; Moderate disease activity: 5.1≥ DAS28 \> 3.2 to 5.1; Low disease activity (LDA) and Remission mean Clinical remission.

Time frame
week 24

Secondary outcomes

1

The percentage of patients who achieve clinical remission using DAS28-ESR.

The percentage of patients whose DAS28 achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2) .

Time frame
week 12
2

Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders

△DAS28 indicates the decline of DAS28-ESR from the baseline to week 30. EULAR response states were classified as follows: good responders were patients with an improvement from baseline (△DAS28-ESR) of \> 1.2 and a DAS28-ESR at week 30 ≤ 3.2. Moderate responders: △DAS28 \> 1.2 and still DAS28 \> 3.2 at week 30, or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 30. Nonresponders：△DAS28 ≤0.6 or DAS28 \>5.1 at week 30. DAS28-defined remission was classified as a score of \<2.6.

Time frame
baseline,week 12,week 24
3

Percentage of participants achieving ACR/EULAR remission

If all of the following 4 parameters are fulfilled, it is defined as remission: TJC ≤ 1, SJC ≤ 1, CRP ≤ 1 mg/dL, Patient global assessment（PGA） ≤ 1 cm (on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease).

Time frame
week 12,week 24
4

Change from baseline Simplified Disease Activity Index (SDAI)

The SDAI is a composite score derived from these measures，that is the count of tender joint count（TJC, 0-28）, swollen joint count（SJC, 0-28）, C-reactive protein (CRP, mg/L), Patient global assessment（PGA）and physician global assessment（PHGA）, each of the last two was assessed on a visual analog scale ranging from 0-10 cm, with higher scores indicating severe disease. SDAI score will be calculated with formula SDAI = TJC + SJC + PGA+PHGA+ CRP. SDAI score exceeding 26 is considered high disease activity; 11 \<SDAI ≤26，moderate disease activity; 3.3 \<SDAI ≤11, low disease activity; remission is SDAI score ≤ 3.3.

Time frame
up to week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Qilu Hospital of Shandong University

Lead sponsor

Source ClinicalTrials.gov
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