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Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

Information source: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Iguratimod (Drug); Leflunomide (Drug); Methotrexate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Jiangsu Simcere Pharmaceutical Co., Ltd.

Overall contact:
weihong zhao, doctor, Phone: +86(25) 8556 6666, Ext: 8701, Email: zhaoweihong@simcere.com

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

weihong zhao, doctor, Phone: +86(25) 8556 6666, Ext: 8701, Email: zhaoweihong@simcere.com

Peking Union Medical College Hospital, Beijing, Beijing 100032, China; Recruiting
Fengchun Zhang, doctor, Phone: +86(10)6915 6114, Email: zhangfccra@yahoo.com.cn
Additional Information

Starting date: September 2013
Last updated: October 23, 2014

Page last updated: August 20, 2015

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