The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment

Browse trials for

• Arthritis 3,554
• Arthritis, Rheumatoid 2,888

Keywords

• Iguratimod

Arthritis

3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.

This study's enrollment of 400 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

Eligibility criteria

Study arms

• Experimental
  Iguratimod

  The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX), hydroxychloroquine (HCQ) , prednisone (Pred) step by step

  Drug: Iguratimod · Drug: MTX · Drug: HCQ · Drug: Pred

Interventions

• DrugIguratimod

  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.

  Also known as: T-614

• DrugMTX

  MTX，7.5mg to 15mg, po, once per week (Qw) prescribed if needed and adjusted due to patient response or unacceptable toxicity develops.

  Also known as: methotrexate

• DrugHCQ

  HCQ，200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.

  Also known as: Hydroxychloroquine

• DrugPred

  Pred, 5-15mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response

  Also known as: Prednisone

Primary outcomes

1. The percentage of patients who achieve clinical remission at week 24 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 at week 12

   The percentage of patients whose DAS28 achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2) at week 12.

   Time frame: week 12

2. The percentage of patients who achieve clinical remission using DAS28-ESR at week 48

   The percentage of patients whose DAS28 achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2) at week 12.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 12 ≤ 3.2. Moderate responders: △DAS28 \> 1.2 and still DAS28 \> 3.2 at week 12, or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 12. Nonresponders：△DAS28 ≤0.6 or DAS28 \>5.1 at week 12. DAS28-defined remission was classified as a score of \<2.6.

   Time frame: week 48

3. The percentage of patients who achieve clinical remission using DAS28-ESR at week 96

   The percentage of patients whose DAS28 achieve remission（DAS28-ESR≤ 2.6）and Low Disease Activity (DAS28-ESR ≤ 3.2) at week 12Nonresponders：△DAS28 ≤0.6，or DAS28 \>5.1 at week 24. DAS28-defined remission was classified as a score of \<2.6.

   Time frame: week 96

4. Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 12

   △DAS28 indicates the decline of DAS28-ESR from the baseline to week 12. 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 12 ≤ 3.2. Moderate responders: △DAS28 \> 1.2 and still DAS28 \> 3.2 at week 12, or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 12. Nonresponders：△DAS28 ≤0.6 or DAS28 \>5.1 at week 12. DAS28-defined remission was classified as a score of \<2.6.

   Time frame: week 12

5. Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 24

   EULAR response states were classified as follows: DAS28-ESR Good responders: △DAS28 \> 1.2 and DAS28 ≤3.2 at week 24. Moderate responders：△DAS28 \> 1.2 and still DAS28 \> 3.2 at week 24; or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 24. Nonresponders：△DAS28 ≤0.6，or DAS28 \>5.1 at week 24. DAS28-defined remission was classified as a score of \<2.6.

   Time frame: week 24

6. Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 48

   EULAR response states were classified as follows: DAS28-ESR Good responders: △DAS28 \> 1.2 and DAS28 ≤3.2 at week 24. Moderate responders：△DAS28 \> 1.2 and still DAS28 \> 3.2 at week 24; or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 24. Nonresponders：△DAS28 ≤0.6，or DAS28 \>5.1 at week 24. DAS28-defined remission was classified as a score of \<2.6.

   Time frame: week 48

7. Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 96

   EULAR response states were classified as follows: DAS28-ESR Good responders: △DAS28 \> 1.2 and DAS28 ≤3.2 at week 24. Moderate responders：△DAS28 \> 1.2 and still DAS28 \> 3.2 at week 24; or 1.2 ≥△DAS28 \> 0.6 and DAS28 ≤ 5.1 at week 24. Nonresponders：△DAS28 ≤0.6，or DAS28 \>5.1 at week 24. DAS28-defined remission was classified as a score of \<2.6.

   Time frame: week 96

8. Percentage of participants achieving ACR/EULAR remission at week 12

   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

9. Percentage of participants achieving ACR/EULAR remission at week 24

   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 24

10. Percentage of participants achieving ACR/EULAR remission at week 48

    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 48

11. Percentage of participants achieving ACR/EULAR remission at week 96

    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 96

12. Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every 3 months

    Percentage of American College of Rheumatology \[ACR\] 20 Criteria Responders every 3 months

    Time frame: Up to week 96

13. 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 96

14. Change from baseline Clinical Disease Activity Index (CDAI)

    CDAI 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）, Patient global assessment（PGA）and physician global assessment（PHGA）, each of the last two was CDAI score will be calculated with formula CDAI = TJC + SJC + PGA + PHGA. CDAI \> 22 is considered high disease activity; 10 \<CDAI ≤ 22, moderate disease activity; 2.8 \<CDAI ≤10, low disease activity; remission is CDAI score ≤2.8.

    Time frame: Up to week 96

15. Change From Baseline in C-reactive Protein (CRP)

    Change from Baseline in C-reactive Protein (CRP), a component index of ACR20 and SDAI, CRP will be measured with blood samples.

    Time frame: Up to week 96

16. Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

    Change from Baseline in ESR, that is a component index of ACR20, DAS28-ESR and SDAI, ESR will be measured with blood samples.

    Time frame: Up to week 96

17. Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)

    Change from Baseline in HAQ-DI, a participant assessed measure of health assessment, shaveing eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item on a single scale has 4 degrees ranging from 0 (no functional difficulty) to 3 (unable to do), with higher scores indicating severe disease.

    Time frame: Up to week 96

18. Incidence of participant withdrawal

    Percentage of participants who withdraw from this study.

    Time frame: Up to week 96

19. Number of participants with"adverse events (AEs)"

    An AE is any untoward medical occurrence in a subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with"adverse events (AEs)"i.e. physical exam abnormalities，vital sign abnormalities，laboratory value abnormalities，symptom or disease (new or exacerbated) temporally associated with the use of a medicinal product.

    Time frame: Up to week 96

Individual participant data

Plan to share: No