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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02275299
• Other study ID #: Tranmod
• Status: Recruiting
• Phase: Phase 4
• First received: October 23, 2014
• Last updated: October 23, 2014
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: October 2014
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: weihong zhao, doctor
• Phone: +86(25) 8556 6666
• Email: zhaoweihong[@]simcere.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Iguratimod
Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
• Leflunomide
Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
• Methotrexate
Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28		week 52	No
Secondary	Change from baseline in modified Total Sharp Score (mTSS)		week 52	No
Secondary	Percentage of patients with ACR 50 response and ACR70 response		week 24,week 52	No
Secondary	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)		week 24, week 52	No
Secondary	Time to achieve the ACR20, ACR50 and ACR70		week 12, week 24, week 40, week 52	No
Secondary	Percentage of patients with Simplified Disease Activity Index (SDAI) = 3.3 and change from baseline in Health Assessment Questionnaire (HAQ)		week 12, week 24, week 40, week 52	No
Secondary	Incidence of adverse events		up to 52 weeks	Yes