Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With 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 Alone or Iguratimod in Combination With Methotrexate Versus Methotrexate Alone in Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01548001
• Other study ID #: SIM-106
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 5, 2012
• Last updated: February 22, 2016
• Start date: May 2012
• Est. completion date: January 2017

Study information

• Verified date: February 2016
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 910
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 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 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

Study Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Iguratimod
25 mg/tablet, taken orally, 2 tablets/day (bid)
• Methotrexate
2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)

Locations

Country	Name	City	State
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai

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		week 52	No
Primary	Change from baseline in modified Total Sharp Score (mTSS)		week 52	No
Secondary	Change from baseline in mTSS		week 24	No
Secondary	Percentage of patients achieving radiographic non-progression		week 24, week 52	No
Secondary	Percentage of patients with ACR 20 response		week 12, week 24, week 40	No
Secondary	Percentage of patients with ACR 50 response		week 12, week 24, week 40, week 52	No
Secondary	Percentage of patients with ACR 70 response		week 12, week 24, week 40, week 52	No
Secondary	Percentage of patients with Simplified Disease Activity Index (SDAI) = 3.3		week 12, week 24, week 40, week 52	No
Secondary	Change from baseline in Health Assessment Questionnaire (HAQ)		week 12, week 24, week 40, week 52	No
Secondary	Incidence of adverse events		up to 2 years	Yes