Clinical trial NCT01548001: Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Iguratimod
Methotrexate
Lead sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-03-08
Enrollment: 910
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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 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

Primary outcomes:
measure: Percentage of patients with ACR 20 response
timeFrame: week 52
measure: Change from baseline in modified Total Sharp Score (mTSS)
timeFrame: week 52
Secondary outcomes:
measure: Change from baseline in mTSS
timeFrame: week 24
measure: Percentage of patients achieving radiographic non-progression
timeFrame: week 24, week 52
measure: Percentage of patients with ACR 20 response
timeFrame: week 12, week 24, week 40
measure: Percentage of patients with ACR 50 response
timeFrame: week 12, week 24, week 40, week 52
measure: Percentage of patients with ACR 70 response
timeFrame: week 12, week 24, week 40, week 52
measure: Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3
timeFrame: week 12, week 24, week 40, week 52
measure: Change from baseline in Health Assessment Questionnaire (HAQ)
timeFrame: week 12, week 24, week 40, week 52
measure: Incidence of adverse events
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Study officials:
affiliation: RenJi Hospital
name: Chunde Bao, MD
role: PRINCIPAL_INVESTIGATOR
References: