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

NCT01893151 | Unknown Phase 4 DMC

• 1 other identifier: SMM-3
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatoid Arthritis

Keywords

Iguratimod; MRI; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

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

  week 52

• Change from baseline in modified Total Sharp Score (mTSS)

  week 52

• Percentage of patients with ACR 20 response

  week 52

• Change in Disease Activity as measured by the DAS28

  week 52

Secondary Outcomes (9)

• Change from baseline in RAMRIS

  week 24

• Change from baseline in mTSS

  week 24

• Percentage of patients with ACR 20 response

  week 10, week 24, week 40

• Change from baseline in Disease Activity Score 28 (DAS28)

  : week 10, week 24, week 40

• Percentage of patients with ACR 50 response

  week 10, week 24, week 40, week 52

Study Arms (2)

Iguratimod

EXPERIMENTAL

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

Drug: Iguratimod

Iguratimod placebo

PLACEBO COMPARATOR

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

Interventions

Iguratimod DRUG

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

Also known as: Iremod

Iguratimod

Iguratimod placebo DRUG

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

Iguratimod placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Third Affiliated Hospital Of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

iguratimod

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jieruo Gu, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 8, 2013
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 23, 2014

Record last verified: 2013-07

Locations

CN (1)