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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Jiangsu Simcere Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01548001
First received: March 5, 2012
Last updated: July 31, 2014
Last verified: July 2014

March 5, 2012
July 31, 2014
May 2012
December 2015   (final data collection date for primary outcome measure)
  • Percentage of patients with ACR 20 response [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in modified Total Sharp Score (mTSS) [ Time Frame: week 52 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01548001 on ClinicalTrials.gov Archive Site
  • Change from baseline in mTSS [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • Percentage of patients achieving radiographic non-progression [ Time Frame: week 24, week 52 ] [ Designated as safety issue: No ]
  • Percentage of patients with ACR 20 response [ Time Frame: week 12, week 24, week 40 ] [ Designated as safety issue: No ]
  • Percentage of patients with ACR 50 response [ Time Frame: week 12, week 24, week 40, week 52 ] [ Designated as safety issue: No ]
  • Percentage of patients with ACR 70 response [ Time Frame: week 12, week 24, week 40, week 52 ] [ Designated as safety issue: No ]
  • Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 [ Time Frame: week 12, week 24, week 40, week 52 ] [ Designated as safety issue: No ]
  • Change from baseline in Health Assessment Questionnaire (HAQ) [ Time Frame: week 12, week 24, week 40, week 52 ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up to 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Long-term Efficacy of Iguratimod Alone or Iguratimod in Combination With Methotrexate in Patients With Rheumatoid Arthritis
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

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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • 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)
  • Experimental: Iguratimod monotherapy
    Intervention: Drug: Iguratimod
  • Experimental: Iguratimod and MTX combination
    Interventions:
    • Drug: Iguratimod
    • Drug: Methotrexate
  • Active Comparator: MTX monotherapy
    Intervention: Drug: Methotrexate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
900
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
China
 
NCT01548001
SIM-106
No
Jiangsu Simcere Pharmaceutical Co., Ltd.
Jiangsu Simcere Pharmaceutical Co., Ltd.
Not Provided
Principal Investigator: Chunde Bao, MD Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Jiangsu Simcere Pharmaceutical Co., Ltd.
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP