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

Primary Purpose

Rheumatoid Arthritis

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Iguratimod

Iguratimod placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Iguratimod, MRI, Rheumatoid Arthritis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Third Affiliated Hospital Of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Iguratimod

Iguratimod placebo

Arm Description

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

Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week;Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week

Outcomes

Primary Outcome Measures

Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS)

Change from baseline in modified Total Sharp Score (mTSS)

Percentage of patients with ACR 20 response

Change in Disease Activity as measured by the DAS28

Secondary Outcome Measures

Change from baseline in RAMRIS

Change from baseline in mTSS

Percentage of patients with ACR 20 response

Change from baseline in Disease Activity Score 28 (DAS28)

Percentage of patients with ACR 50 response

Percentage of patients with ACR 70 response

Percentage of patients with Simplified Disease Activity Index (SDAI) ≤ 3.3

Change from baseline in Simplified Disease Activity Index (SDAI)

Change from baseline in Health Assessment Questionnaire (HAQ)

Full Information

NCT ID

NCT01893151

First Posted

July 2, 2013

Last Updated

October 21, 2014

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01893151

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Unknown status

Study Start Date

July 2012 (undefined)

Primary Completion Date

December 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

Keywords

Iguratimod, MRI, Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iguratimod

Arm Type

Experimental

Arm Description

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

Arm Title

Iguratimod placebo

Arm Type

Placebo Comparator

Arm Description

Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week;Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week

Intervention Type

Drug

Intervention Name(s)

Iguratimod

Other Intervention Name(s)

Iremod

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Iguratimod placebo

Intervention Description

Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week; Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week.

Primary Outcome Measure Information:

Title

Change from baseline in RA magnetic resonance imaging scoring system (RAMRIS)

Time Frame

week 52

Title

Change from baseline in modified Total Sharp Score (mTSS)

Time Frame

week 52

Title

Percentage of patients with ACR 20 response

Time Frame

week 52

Title

Change in Disease Activity as measured by the DAS28

Time Frame

week 52

Secondary Outcome Measure Information:

Title

Change from baseline in RAMRIS

Time Frame

week 24

Title

Change from baseline in mTSS

Time Frame

week 24

Title

Percentage of patients with ACR 20 response

Time Frame

week 10, week 24, week 40

Title

Change from baseline in Disease Activity Score 28 (DAS28)

Time Frame

: week 10, week 24, week 40

Title

Percentage of patients with ACR 50 response

Time Frame