Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Iguratimod, Methotrexate
Brief summary
This study is intended to evaluate the efficacy and safety of Iguratimod alone or Iguratimod in combination with Methotrexate (MTX) versus Methotrexate alone in patients with Rheumatoid Arthritis (RA).
Interventions
DRUGIguratimod
25 mg/tablet, taken orally, 2 tablets/day (bid)
DRUGMethotrexate
2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)
Sponsors
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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 3 months to 2 years from the time of the initial diagnosis * Subjects have active RA at the time of screening * Subjects are naive to MTX or RA related biologics * Written informed consent
Exclusion criteria
* Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry * Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc. * ALT \>1.5×ULN, AST \>1.5×ULN, Cr \>135umol/L * WBC\<4×109/L，HGB\<85g/L，PLT\<100×109/L * Subjects with serious cardiovascular, renal, hematologic or endocrine diseases * Pregnant or lactating women * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with ACR 20 response | week 52 |
| Change from baseline in modified Total Sharp Score (mTSS) | week 52 |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with ACR 20 response | week 12, week 24, week 40 |
| Percentage of patients with ACR 50 response | week 12, week 24, week 40, week 52 |
| Percentage of patients with ACR 70 response | week 12, week 24, week 40, week 52 |
| Change from baseline in mTSS | week 24 |
| Change from baseline in Health Assessment Questionnaire (HAQ) | week 12, week 24, week 40, week 52 |
| Incidence of adverse events | up to 2 years |
| Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 | week 12, week 24, week 40, week 52 |
| Percentage of patients achieving radiographic non-progression | week 24, week 52 |
Countries
China
Outcome results
None listed