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

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01548001

Collaborator

(none)

910

Enrollment

Location

Arms

Duration (Months)

16.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Drug: Iguratimod Drug: Methotrexate	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

910 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

May 1, 2012

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Jan 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Iguratimod monotherapy	Drug: Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid)
Experimental: Iguratimod and MTX combination	Drug: Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)
Active Comparator: MTX monotherapy	Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)

Arm

Intervention/Treatment

Experimental: Iguratimod monotherapy

Drug: Iguratimod

25 mg/tablet, taken orally, 2 tablets/day (bid)

Experimental: Iguratimod and MTX combination

Drug: Iguratimod

25 mg/tablet, taken orally, 2 tablets/day (bid)

Drug: Methotrexate

2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)

Active Comparator: MTX monotherapy

Drug: Methotrexate

2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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]
Percentage of patients with ACR 70 response [week 12, week 24, week 40, week 52]
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 [week 12, week 24, week 40, week 52]
Change from baseline in Health Assessment Questionnaire (HAQ) [week 12, week 24, week 40, week 52]
Incidence of adverse events [up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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