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

Phase 4

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Iguratimod; Drug: Methotrexate

• Registration Number: NCT01548001
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-05
• Study First Submitted QC: 2012-03-05
• Study First Posted: 2012-03-08
• Study Start: 2012-05
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-22
• Last Update Posted: 2016-02-23
• Primary Completion: 2016-11
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 910

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Iguratimod and MTX combination	Iguratimod	-
Iguratimod and MTX combination	Methotrexate	-
MTX monotherapy	Methotrexate	-
Iguratimod monotherapy	Iguratimod	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients with ACR 20 response	week 52
Change from baseline in modified Total Sharp Score (mTSS)	week 52

Secondary Outcome Measures

Name	Time	Method
Change from baseline in mTSS	week 24
Percentage of patients achieving radiographic non-progression	week 24, week 52
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
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 with ACR 70 response	week 12, week 24, week 40, week 52
Change from baseline in Health Assessment Questionnaire (HAQ)	week 12, week 24, week 40, week 52

Trial Locations

Locations (1)

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China