A study of the relationship between the HLA-DR beta 1 genotype and therapeutic response of abatacept (ABT) in patients with rheumatoid arthritis (RA)
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-UMIN000020046
- Lead Sponsor
- Matsuyama Red Cross Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Not provided
1) Patients with serious infections including active tuberculosis 2) Patients with a history of hypersensitivity to ABT or any other excipient of ABT 3) Patients with a history of treatment with anti-rheumatic biological agents 4) Patients administered >= 10 mg/day of systemic corticosteroid preparation as prednisolone equivalent within 28 days before registration day 5) Patients with confirmed hepatitis B (except for HBs/HBc antibody-positive and HBs antigen-negative patients) or hepatitis C at the time of resistration 6) Patients with complications of chronic obstructive pulmonary disease 7) Patients with a history of tuberculosis 8) Patients with complications of extra-articular manifestations such as interstitial pneumonitis 9) Patients whose antinuclear antibody is >160-fold 10) Patients with positive for specific autoantibody against connective tissue disease 11) Patients with the following complications: serious renal disease, liver disease, hematologic disease, digestive system disease, diabetes, malignancy (including a history of malignancy) , thyroid disease, autoimmune disease except RA (chronic thyroiditis and Sjogren's syndrome are eliminated), lung disease, cardiovascular disease, neurological disease, eye disease and brain disease 12) Patients who had undergone surgical therapy for RA such as synovectomy, arthroplasty within 6 months (180 days) before first administration 13) Patients who are pregnant, nursing, possibly pregnant or plan to become pregnant during the research period 14) Patients who are drug or alcohol dependence, or those suspected 15) Patients deemed inappropriate to participate in the research by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of the patients whose DAS28-ESR score was <2.6 at week 24
- Secondary Outcome Measures
Name Time Method Clinical improvement 1) Rate of the patients whose DAS28-CRP score achieved <2.3 at week 24 2) Clinical remission rate defined by SDAI at week 52