Effectiveness of Iguratimod Versus Placebo to Treat Early Rheumatoid Arthritis on MRI

October 21, 2014 updated by: Jiangsu Simcere Pharmaceutical Co., Ltd.

A Randomized, Double-blind Study to Evaluate the Efficacy of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)

The purpose of this study is to evaluate the efficacy of Iguratimod versus placebo on synovial inflammation,bone erosion and bone edema as measured by MRI of wrist and Metacarpophalangeal joints in patients with early Rheumatoid Arthritis (RA).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Magnetic resonance imaging (MRI) is a powerful imaging modality that is now widely used in both scientific research and clinical settings to visualise joints of patients with RA. MRI is able to image structural damage and soft tissue changes, ie, synovitis, bone oedema, damage to cartilage and bone, as well as tendon pathology. MRI is more responsive to change in joint damage and can be used to monitor disease progression.

In this studly,MRI of the dominant wrist was performed at baseline ,24 weeks and at 52 weeks, using a 1.5T or 3.0T MRI with a dedicated high-resolution wrist phased array coil.The same scanner and wrist coil were used for three examinations. The hand was placed in the wrist coil at the patient's side with the coil anchored to the base tray to reduce motion artefacts. The MRI sequences in this study included the OMERACT recommended MRI core set of sequences.

Study Type

Interventional

Enrollment (Anticipated)

200

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Third Affiliated Hospital of Sun Yat-sen University
        • Contact:

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

18 years to 65 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
  • Functional Class II-III
  • Subjects have active RA at the time of screening
  • Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
  • Must have at least 4 tender joints and 4 swollen joints(involved in DAS28) and among these,at least one swollen Metacarpophalangeal joint is essential
  • Has a C-reactive protein ≥ 10 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
  • Written informed consent

Exclusion Criteria:

  • Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), biological agents or tripterygium within 12 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 or Cr >1.5mg
  • WBC<4×109/L，HGB<85g/L，PLT<100×109/L
  • Subjects with serious cardiovascular, renal, hematologic,endocrine diseases or malignant
  • Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
  • Pregnant, intend to become pregnant, or are breastfeeding
  • Subjects with other rheumatological diseases such as SLE, mixed connective tissue disease, scleroderma, polymyositis, etc
  • Subjects with inflammatory arthritis, such as gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease
  • Subjects with intra-articular corticosteroid injections within 6 weeks prior to study entry
  • 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Iguratimod
Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
Drug: Iguratimod
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
Other Names:
  • Iremod
PLACEBO_COMPARATOR: Iguratimod placebo
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week;Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week
Drug: Iguratimod placebo
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week; Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week.

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
Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS)
Time Frame: week 52
week 52
Change in Disease Activity as measured by the DAS28
Time Frame: week 52
week 52

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in mTSS
Time Frame: week 24
week 24
Change from baseline in RAMRIS
Time Frame: week 24
week 24
Percentage of patients with ACR 20 response
Time Frame: week 10, week 24, week 40
week 10, week 24, week 40
Change from baseline in Disease Activity Score 28 (DAS28)
Time Frame: : week 10, week 24, week 40
: week 10, week 24, week 40
Percentage of patients with ACR 50 response
Time Frame: week 10, week 24, week 40, week 52
week 10, week 24, week 40, week 52
Percentage of patients with ACR 70 response
Time Frame: week 10, week 24, week 40, week 52
week 10, week 24, week 40, week 52
Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3
Time Frame: week 10, week 24, week 40, week 52
week 10, week 24, week 40, week 52
Change from baseline in Simplified Disease Activity Index (SDAI)
Time Frame: week 10, week 24, week 40, week 52
week 10, week 24, week 40, week 52
Change from baseline in Health Assessment Questionnaire (HAQ)
Time Frame: week 10, week 24, week 40, week 52
week 10, week 24, week 40, week 52

Collaborators and Investigators

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

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

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

July 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

July 2, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (ESTIMATE)

July 8, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

October 23, 2014

Last Update Submitted That Met QC Criteria

October 21, 2014

Last Verified

July 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMM-3

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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