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

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ClinicalTrials.gov Identifier: NCT01893151
Recruitment Status : Unknown
Verified July 2013 by Jiangsu Simcere Pharmaceutical Co., Ltd..
Recruitment status was:  Recruiting
First Posted : July 8, 2013
Last Update Posted : October 23, 2014
Sponsor:
Information provided by (Responsible Party):
Jiangsu Simcere Pharmaceutical Co., Ltd.

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Iguratimod Drug: Iguratimod placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 of Iguratimod Versus Placebo in Patients With Rheumatoid Arthritis on Magnetic Resonance Imaging (MRI)
Study Start Date : July 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

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Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS) [ Time Frame: week 52 ]
  2. Change from baseline in modified Total Sharp Score (mTSS) [ Time Frame: week 52 ]
  3. Percentage of patients with ACR 20 response [ Time Frame: week 52 ]
  4. Change in Disease Activity as measured by the DAS28 [ Time Frame: week 52 ]

Secondary Outcome Measures :
  1. Change from baseline in RAMRIS [ Time Frame: week 24 ]
  2. Change from baseline in mTSS [ Time Frame: week 24 ]
  3. Percentage of patients with ACR 20 response [ Time Frame: week 10, week 24, week 40 ]
  4. Change from baseline in Disease Activity Score 28 (DAS28) [ Time Frame: : week 10, week 24, week 40 ]
  5. Percentage of patients with ACR 50 response [ Time Frame: week 10, week 24, week 40, week 52 ]
  6. Percentage of patients with ACR 70 response [ Time Frame: week 10, week 24, week 40, week 52 ]
  7. Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3 [ Time Frame: week 10, week 24, week 40, week 52 ]
  8. Change from baseline in Simplified Disease Activity Index (SDAI) [ Time Frame: week 10, week 24, week 40, week 52 ]
  9. Change from baseline in Health Assessment Questionnaire (HAQ) [ Time Frame: week 10, week 24, week 40, week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
  • 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
Contacts and Locations
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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): NCT01893151


Locations
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China, Guangdong
Third Affiliated Hospital Of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Gu       gujieruo@163.com   
Sponsors and Collaborators
Jiangsu Simcere Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Jieruo Gu, Doctor Third Affiliated Hospital, Sun Yat-Sen University
More Information
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Responsible Party: Jiangsu Simcere Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01893151    
Other Study ID Numbers: SMM-3
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: October 23, 2014
Last Verified: July 2013
Keywords provided by Jiangsu Simcere Pharmaceutical Co., Ltd.:
Iguratimod
MRI
Rheumatoid Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases