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

February 22, 2016 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

910

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mTSS
Time Frame: week 24
week 24
Percentage of patients achieving radiographic non-progression
Time Frame: week 24, week 52
week 24, week 52
Percentage of patients with ACR 20 response
Time Frame: week 12, week 24, week 40
week 12, week 24, week 40
Percentage of patients with ACR 50 response
Time Frame: week 12, week 24, week 40, week 52
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
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
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
week 12, week 24, week 40, week 52
Incidence of adverse events
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Chunde Bao, MD, Renji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

March 5, 2012

First Submitted That Met QC Criteria

March 5, 2012

First Posted (Estimate)

March 8, 2012

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

February 22, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIM-106

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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