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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.
Verified January 2013 by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier:
NCT01548001
First received: March 5, 2012
Last updated: January 14, 2013
Last verified: January 2013
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by Jiangsu Simcere Pharmaceutical R&D Co. Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 900
Study Start Date: May 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01548001

Locations
China
Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, China
Contact: Chunde Bao, MD     86-021-63284622        
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
Investigators
Principal Investigator: Chunde Bao, MD Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine
  More Information

No publications provided

Responsible Party: Jiangsu Simcere Pharmaceutical R&D Co. Ltd.
ClinicalTrials.gov Identifier: NCT01548001     History of Changes
Other Study ID Numbers: SIM-106
Study First Received: March 5, 2012
Last Updated: January 14, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Simcere Pharmaceutical R&D 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
 Pharmacologic Actions
Therapeutic Uses
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

ClinicalTrials.gov processed this record on May 23, 2013