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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01548001
First Posted: March 8, 2012
Last Update Posted: February 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.
  Purpose
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 Intervention Phase
Rheumatoid Arthritis Drug: Iguratimod Drug: Methotrexate Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Percentage of patients with ACR 20 response [ Time Frame: week 52 ]
  • Change from baseline in modified Total Sharp Score (mTSS) [ Time Frame: week 52 ]

Secondary Outcome Measures:
  • Change from baseline in mTSS [ Time Frame: week 24 ]
  • Percentage of patients achieving radiographic non-progression [ Time Frame: week 24, week 52 ]
  • Percentage of patients with ACR 20 response [ Time Frame: week 12, week 24, week 40 ]
  • Percentage of patients with ACR 50 response [ Time Frame: week 12, week 24, week 40, week 52 ]
  • Percentage of patients with ACR 70 response [ Time Frame: week 12, week 24, week 40, week 52 ]
  • Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 [ Time Frame: week 12, week 24, week 40, week 52 ]
  • 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 2 years ]

Enrollment: 910
Study Start Date: May 2012
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01548001


Locations
China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Chunde Bao, MD Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  More Information

Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01548001     History of Changes
Other Study ID Numbers: SIM-106
First Submitted: March 5, 2012
First Posted: March 8, 2012
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Rheumatoid Arthritis
Iguratimod
Methotrexate

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors