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

Simcere

Status and phase

Unknown

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: Iguratimod placebo

Drug: Iguratimod

Study type

Interventional

Funder types

Industry

Identifiers

NCT01893151

SMM-3

Details and patient eligibility

About

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).

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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