Rheumatoid arthritis
Conditions
Interventions
ABT should be administered intravenously for all patients at a dose of 250 mg until week 8. Thereafter, it is permitted to continue intravenous infusion or switch to 125 mg/ml solution for subcutaneou
Sponsors
Matsuyama Red Cross Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients whose written informed consent can be obtained and are >=20, =<75 years of age at the time of informed consent acquisition (regardless of sex, hospitalization or outpatient). 2) Patients with a diagnosis of RA according to the 2010 ACR-EULAR classification criteria for RA and whose duration of disease from diagnosis is >= 3 months and < 10 years before the day of first administration 3) CRP is >= 0.6 mg/dL, or ESR is >= 28 mm/hr and DAS28-ESR score is >= 3.2 before the day of first administration. 4) ACPA-positive patients whose ACPA is >4.5 U/mL and ACPA-negative patients whose ACPA is <= 4.5 U/mL before the day of first administration.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of the patients whose DAS28-ESR score was <2.6 at week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKensuke Oryoji
Matsuyama Red Cross Hospital Division of rheumatoid arthritis
Outcome results
None listed