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Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT02275299
Recruitment Status : Unknown
Verified October 2014 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : October 27, 2014
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE October 23, 2014
First Posted Date  ICMJE October 27, 2014
Last Update Posted Date October 27, 2014
Study Start Date  ICMJE September 2013
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
Percentage of patients with ACR 20 response and Change in Disease Activity as measured by the DAS28 [ Time Frame: week 52 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2014)
  • Change from baseline in modified Total Sharp Score (mTSS) [ Time Frame: week 52 ]
  • Percentage of patients with ACR 50 response and ACR70 response [ Time Frame: week 24,week 52 ]
  • Change from baseline in number of swollen and tender joins, Erythrocyte sedimentation rate (ESR) ,C-reactive protein (CRP),anti-citrullinated-protein antibody (ACPA) and heumatoid factor(RF) [ Time Frame: week 24, week 52 ]
  • Time to achieve the ACR20, ACR50 and ACR70 [ Time Frame: week 12, week 24, week 40, week 52 ]
  • Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 and change from baseline in Health Assessment Questionnaire (HAQ) [ Time Frame: week 12, week 24, week 40, week 52 ]
  • Incidence of adverse events [ Time Frame: up to 52 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis
Official Title  ICMJE A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Iguratimod or Leflunomide in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
Brief Summary This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Iguratimod
    Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
    Other Name: Iremod
  • Drug: Leflunomide
    Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
  • Drug: Methotrexate
    Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks
Study Arms  ICMJE
  • Experimental: Iguratimod and MTX combination
    Drug:Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid) Drug:MTX 2.5 mg/tablet, taken orally once a week, 4 tablets/week
    Interventions:
    • Drug: Iguratimod
    • Drug: Methotrexate
  • Active Comparator: Leflunomide and MTX combination
    Drug: Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid) Drug: Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week
    Interventions:
    • Drug: Leflunomide
    • Drug: Methotrexate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 23, 2014)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2016
Estimated Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 more than 3 months from the time of the initial diagnosis
  • Functional Class II-III
  • Subjects have active RA at the time of screening
  • Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
  • For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28>3.2
  • Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline
  • Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
  • Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
  • Written informed consent

Exclusion Criteria:

  • Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
  • Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
  • Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
  • Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
  • ALT >1.5×ULN, AST >1.5×ULN, Cr >135umol/L, total bilirubin>1.5×ULN
  • WBC<4×109/L,HGB<85g/L,PLT<100×109/L
  • Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant
  • Women of Pregnant or breastfeeding, and male or female with recent plan to conception
  • Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02275299
Other Study ID Numbers  ICMJE Tranmod
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jiangsu Simcere Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Jiangsu Simcere Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jiangsu Simcere Pharmaceutical Co., Ltd.
Verification Date October 2014

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