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

S

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups, including a placebo group

Iguratimod
Experimental group
Description:
Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
Treatment:
Drug: Iguratimod
Iguratimod placebo
Placebo Comparator group
Description:
Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week;Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week
Treatment:
Drug: Iguratimod placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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