Back to resultsThe Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment
Primary Purpose
Arthritis, Rheumatoid
Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Iguratimod
MTX
HCQ
Pred
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid focused on measuring Iguratimod
Eligibility Criteria
Inclusion Criteria: -
- RA: Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis(RA);
- ERA: Subjects diagnosed by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR); or by 2012 Chinese classification criteria of early rheumatoid arthritis (ERA), and not match the 1987 ACR criteria for RA.
- Age ≥16 years;
- Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;
- Patients can be naïve to any DMARDs, or relapse due to DMARDs drug suspended;
- Patients have a history of using csDMARDs including csDMARDs（methotrexate，leflunomide, hydroxychloroquine, sulfasalazine, tacrolimus) , any biologic DMARDs（TNFi，tocilizumab or Tofacitinib），glucocorticoid (prednisone，methylprednisolone) or Chinese traditional Medicine（including tripterygium Glycosides, sinomenine）for 3 months, but couldn't achieve clinical remission or intolerance；
Exclusion Criteria:
- Patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis B;
- Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x 10^9 / L;
- Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two times higher than the upper limit of normal;
- Renal insufficiency: serum Cr ≥ 176 umol / L;
- Pregnant or nursing women (breastfeeding) ；
- Patients has a history of malignancy (cure time in less than 5 years);
- Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
- Other comorbidities that cannot be treated with immune suppressants. In addition, once patients experience severe adverse drug reactions、ineffective treatment or rapid progression of rheumatoid arthritis, then quit this research.
Sites / Locations
- Qilu Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Iguratimod
Arm Description
The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX), hydroxychloroquine (HCQ) , prednisone (Pred) step by step
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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).
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).
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).
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).
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
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.
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.
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.
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.
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.
Incidence of participant withdrawal
Percentage of participants who withdraw from this study.
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.
Full Information
NCT ID
NCT03855007
First Posted
February 15, 2019
Last Updated
September 19, 2022
Sponsor
Qilu Hospital of Shandong University
1. Study Identification
Unique Protocol Identification Number
NCT03855007
Brief Title
The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment
Official Title
Prospective Clinical Study to Observe the Efficacy and Safety of Iguratimod in Rheumatoid Arthritis and Early Rheumatoid Arthritis Patients for 6 Months Treatment in China
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qilu Hospital of Shandong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to observed prospectively the efficacy and safety of 6 months treatment of iguratimod alone, or with methotrexate (MTX), hydroxychloroquine (HCQ) and prednisone step by step on Chinese rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients who were naïve or shown insufficiency response or intolerance to DMARDs. If volunteered, patients who completed the 6-month study can continue to follow our plans for 24 months.
Detailed Description
This study will enroll 200 cases of rheumatoid arthritis (RA) and early rheumatoid arthritis (ERA) patients in China, who are naïve or shown insufficiency response or intolerance to DMARDs. The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX)/ hydroxychloroquine (HCQ) / prednisone (Pred) step by step for 6 months if participants are in medium or high disease activity (DAS28≥3.2). Participants can choose to continue the study up to 24 months.The efficacy and safety of 6 months and 24 months Iguratimod treatment in RA and ERA patients will be evaluated with DAS28-ESR and other disease activity indices.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
Keywords
Iguratimod
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Drug: Iguratimod（T-614），25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
Drug: Methotrexate （MTX），7.5mg to 15mg, po, once per week (Qw) prescribed if needed and adjusted due to patient response or unacceptable toxicity develops.
Drug: Hydroxychloroquine （HCQ），200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Drug: Prednisone （Pred）： 5-15mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iguratimod
Arm Type
Experimental
Arm Description
The participants plan to be treated with iguratimod alone, or along with methotrexate (MTX), hydroxychloroquine (HCQ) , prednisone (Pred) step by step
Intervention Type
Drug
Intervention Name(s)
Iguratimod
Other Intervention Name(s)
T-614
Intervention 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(s)
MTX
Other Intervention Name(s)
methotrexate
Intervention Description
MTX，7.5mg to 15mg, po, once per week (Qw) prescribed if needed and adjusted due to patient response or unacceptable toxicity develops.
Intervention Type
Drug
Intervention Name(s)
HCQ
Other Intervention Name(s)
Hydroxychloroquine
Intervention Description
HCQ，200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Intervention Type
Drug
Intervention Name(s)
Pred
Other Intervention Name(s)
Prednisone
Intervention Description
Pred, 5-15mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
Primary Outcome Measure Information:
Title
The percentage of patients who achieve clinical remission at week 24 using European League Against Rheumatism (EULAR) response criteria DAS28
Description
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 Outcome Measure Information:
Title
The percentage of patients who achieve clinical remission using DAS28-ESR at week 12
Description
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
Title
The percentage of patients who achieve clinical remission using DAS28-ESR at week 48
Description
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
Title
The percentage of patients who achieve clinical remission using DAS28-ESR at week 96
Description
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
Title
Percentage of Disease Activity Score 28 (DAS28) -ESR Criteria Responders at week 12
Description
△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
Title
Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 24
Description
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
Title
Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 48
Description
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
Title
Percentage of Disease Activity Score 28 (DAS28)-ESR Criteria Responders at week 96
Description
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
Title
Percentage of participants achieving ACR/EULAR remission at week 12
Description
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
Title
Percentage of participants achieving ACR/EULAR remission at week 24
Description
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
Title
Percentage of participants achieving ACR/EULAR remission at week 48
Description
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
Title
Percentage of participants achieving ACR/EULAR remission at week 96
Description
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
Title
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every 3 months
Description
Percentage of American College of Rheumatology [ACR] 20 Criteria Responders every 3 months
Time Frame
Up to week 96
Title
Change from baseline Simplified Disease Activity Index (SDAI)
Description
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
Title
Change from baseline Clinical Disease Activity Index (CDAI)
Description
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
Title
Change From Baseline in C-reactive Protein (CRP)
Description
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
Title
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Description
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
Title
Change from baseline Health Assessment Questionnaire Disability Index (HAQ-DI)
Description
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
Title
Incidence of participant withdrawal
Description
Percentage of participants who withdraw from this study.
Time Frame
Up to week 96
Title
Number of participants with"adverse events (AEs)"
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: -
RA: Patients diagnosed based on 1987 ACR classification criteria for rheumatoid arthritis(RA);
ERA: Subjects diagnosed by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR); or by 2012 Chinese classification criteria of early rheumatoid arthritis (ERA), and not match the 1987 ACR criteria for RA.
Age ≥16 years;
Extra-articular manifestations (such as pulmonary fibrosis, proteinuria, leukopenia and peripheral neuropathy ) of RA patients are stable or no significant progress;
Patients can be naïve to any DMARDs, or relapse due to DMARDs drug suspended;
Patients have a history of using csDMARDs including csDMARDs（methotrexate，leflunomide, hydroxychloroquine, sulfasalazine, tacrolimus) , any biologic DMARDs（TNFi，tocilizumab or Tofacitinib），glucocorticoid (prednisone，methylprednisolone) or Chinese traditional Medicine（including tripterygium Glycosides, sinomenine）for 3 months, but couldn't achieve clinical remission or intolerance；
Exclusion Criteria:
Patients with acute or chronic infections such as active bacterial, viral, fungal, tuberculosis infection or active hepatitis B;
Platelet counts(PLT) <80 x 10^9 / L, or white blood cell (WBC) <3 x 10^9 / L;
Propionate acid aminotransferase (ALT) or aspartate aminotransferase (AST) is two times higher than the upper limit of normal;
Renal insufficiency: serum Cr ≥ 176 umol / L;
Pregnant or nursing women (breastfeeding) ；
Patients has a history of malignancy (cure time in less than 5 years);
Patients with severe or poorly controlled hypertension, diabetes or cardiac dysfunction;
Other comorbidities that cannot be treated with immune suppressants. In addition, once patients experience severe adverse drug reactions、ineffective treatment or rapid progression of rheumatoid arthritis, then quit this research.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Lv, Dr.
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Study Director
Facility Information:
Facility Name
Qilu Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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The Clinical Efficacy and Safety of Iguratimod in RA and Early RA Patients for 6 Months Treatment
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