Identification of the best treatment strategy in Korean patients with early rheumatoid arthritis

Korean intensive management of early rheumatoid arthritis (KIMERA trial)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0000089

Enrollment

200

Registered

2011-01-26

Start date

2008-12-01

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : 7.1.1. Group 1 ( methotrexate monotherapy) 1) MTX (10 mg/wk) 2) MTX (15 mg/wk) 3) MTX (20 mg/wk) 4) MTX (20 mg/wk) + SSZ (1000 mg) + HCQ (200 mg) 5) MTX (20 mg/wk) + SSZ (2000 mg) + HCQ (400 m

weekly tapering) 2) (eight weeks after) MTX (15 mg/wk) + SSZ (1500 mg) + HCQ (300 mg) 3) MTX (20 mg/wk) + SSZ (2000 mg) + HCQ (400 mg) 4) MTX (20 mg/wk) + LFM (10 mg) 5) MTX (20 mg/wk) + LFM (2

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 5.1.1 Fullfilment of American College of Rheumatology criteria for the diagnosis of rheumatoid arthritis * Criteria (requires at least 4 of the followings) Morning stiffness ( ) Arthritis of three or more joint areas ( ) Arthritis of hand joints ( ) Symmetric arthritis ( ) Rheumatoid nodules ( ) Serum rheumatoid factor ( ) Radiologic changes ( ) 5.1.2. Duration of symptom less than one year 5.1.3. Age over 18 years 5.1.4. Active disease status 5.1.4.1. Number of swollen joint should be more than 6 out of 66 joints 5.1.4.2. Number of tender joint should be more than 6 out of 68 joints 5.1.4.3. ESR > 28 mm/hour or CRP > 1.0 mg/dl 5.1.4.4. Functional class should be in the range of I to III

Exclusion criteria

Exclusion criteria: 5.2.1. Previous use of DMARDs 5.2.2. Chronic inflammatory diseases : systemic lupus erythematosus, inflammatory myopathy, systemic sclerosis, vasculitis, spondyloarthritis, crystal induced arthritis 5.2.3. Other systemic illness : Malignancy in last 5 years Severe cardiopulmonary, gastrointestinal, endocrinologic, hematologic, neurologic Diseases Major trauma or surgery in last 8 weeks Drug abuse Current pregnancy or having a chance to be pregnant Infection (body temperature = 38 °C, HBsAg (+), anti-HCV (+), active tuberculosis) 5.2.4. laboratory tests WBC 68 IU/L, ALT > 92 IU/L, T.bili > 2.4 mg/dL, Cr > 1.4 mg/dL

Design outcomes

Primary

Measure	Time frame
Rate of Complete Remission	—

Secondary

Measure	Time frame
ACR response rate;HAQ score	—

Countries

Korea, Republic of

Contacts

Public ContactKwang-Hoon Lee

Yonsei University

Outcome results