Back to resultsStudy of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Iguratimod
Leflunomide
Methotrexate
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
- Rheumatoid Arthritis for more than 3 months from the time of the initial diagnosis
- Functional Class II-III
- Subjects have active RA at the time of screening
- Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
- For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28>3.2
- Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline
- Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
- Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
- Written informed consent
Exclusion Criteria:
- Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
- Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
- Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
- Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
- ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN
- WBC<4×109/L，HGB<85g/L，PLT<100×109/L
- Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant
- Women of Pregnant or breastfeeding, and male or female with recent plan to conception
- Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
- Allergic to any of the study drugs
- History of alcoholism
- Subjects with mental illness
- Subjects receiving live vaccines recently
- Subjects participating in other clinical study within 3 months prior to study entry
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Iguratimod and MTX combination
Leflunomide and MTX combination
Arm Description
Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Outcomes
Primary Outcome Measures
Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28
Secondary Outcome Measures
Change from baseline in modified Total Sharp Score (mTSS)
Percentage of patients with ACR 50 response and ACR70 response
Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF)
Time to achieve the ACR20, ACR50 and ACR70
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)
Incidence of adverse events
Full Information
NCT ID
NCT02275299
First Posted
October 23, 2014
Last Updated
October 23, 2014
Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02275299
Brief Title
Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis
Official Title
A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
February 2016 (Anticipated)
Study Completion Date
February 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
4. Oversight
5. Study Description
Brief Summary
This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Iguratimod and MTX combination
Arm Type
Experimental
Arm Description
Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Arm Title
Leflunomide and MTX combination
Arm Type
Active Comparator
Arm Description
Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week
Intervention Type
Drug
Intervention Name(s)
Iguratimod
Other Intervention Name(s)
Iremod
Intervention Description
Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Intervention Description
Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
Intervention Type
Drug
Intervention Name(s)
Methotrexate
Intervention Description
Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks
Primary Outcome Measure Information:
Title
Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28
Time Frame
week 52
Secondary Outcome Measure Information:
Title
Change from baseline in modified Total Sharp Score (mTSS)
Time Frame
week 52
Title
Percentage of patients with ACR 50 response and ACR70 response
Time Frame
week 24,week 52
Title
Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF)
Time Frame
week 24, week 52
Title
Time to achieve the ACR20, ACR50 and ACR70
Time Frame
week 12, week 24, week 40, week 52
Title
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)
Time Frame
week 12, week 24, week 40, week 52
Title
Incidence of adverse events
Time Frame
up to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
Rheumatoid Arthritis for more than 3 months from the time of the initial diagnosis
Functional Class II-III
Subjects have active RA at the time of screening
Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28>3.2
Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline
Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
Written informed consent
Exclusion Criteria:
Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN
WBC<4×109/L，HGB<85g/L，PLT<100×109/L
Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant
Women of Pregnant or breastfeeding, and male or female with recent plan to conception
Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
Allergic to any of the study drugs
History of alcoholism
Subjects with mental illness
Subjects receiving live vaccines recently
Subjects participating in other clinical study within 3 months prior to study entry
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
weihong zhao, doctor
Phone
+86(25) 8556 6666
Ext
8701
Email
zhaoweihong@simcere.com
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fengchun Zhang, doctor
Phone
+86（10）6915 6114
Email
zhangfccra@yahoo.com.cn
12. IPD Sharing Statement
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Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis
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