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

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01893151
• Other study ID #: SMM-3
• Status: Recruiting
• Phase: Phase 4
• First received: July 2, 2013
• Last updated: October 21, 2014
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: July 2013
• Source: Jiangsu Simcere Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Iguratimod
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
• 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.

Locations

Country	Name	City	State
China	Third Affiliated Hospital Of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Simcere Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS)		week 52	Yes
Primary	Change from baseline in modified Total Sharp Score (mTSS)		week 52	Yes
Primary	Percentage of patients with ACR 20 response		week 52	Yes
Primary	Change in Disease Activity as measured by the DAS28		week 52	Yes
Secondary	Change from baseline in RAMRIS		week 24	Yes
Secondary	Change from baseline in mTSS		week 24	Yes
Secondary	Percentage of patients with ACR 20 response		week 10, week 24, week 40	Yes
Secondary	Change from baseline in Disease Activity Score 28 (DAS28)		: week 10, week 24, week 40	Yes
Secondary	Percentage of patients with ACR 50 response		week 10, week 24, week 40, week 52	Yes
Secondary	Percentage of patients with ACR 70 response		week 10, week 24, week 40, week 52	Yes
Secondary	Percentage of patients with Simplified Disease Activity Index (SDAI) = 3.3		week 10, week 24, week 40, week 52	Yes
Secondary	Change from baseline in Simplified Disease Activity Index (SDAI)		week 10, week 24, week 40, week 52	Yes
Secondary	Change from baseline in Health Assessment Questionnaire (HAQ)		week 10, week 24, week 40, week 52	Yes