Clinical trial NCT02275299: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28
timeFrame: week 52
Secondary outcomes:
measure: Change from baseline in modified Total Sharp Score (mTSS)
timeFrame: week 52
measure: Percentage of patients with ACR 50 response and ACR70 response
timeFrame: week 24,week 52
measure: 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)
timeFrame: week 24, week 52
measure: Time to achieve the ACR20, ACR50 and ACR70
timeFrame: week 12, week 24, week 40, week 52
measure: Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)
timeFrame: week 12, week 24, week 40, week 52
measure: Incidence of adverse events
timeFrame: up to 52 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: