Rheumatoid Arthritis, Nos
Conditions
Interventions
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Powder for solution for infusion
INN or Propos
Sponsors
Bristol Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject is willing to participate in the study and has signed the informed consent. 2) Males or females (not nursing and not pregnant) = 18 years of age. Males and women of child-bearing potential are eligible if they are practicing effective contraceptive measures. 3) Subjects must meet the criteria of the American Rheumatism Association (1987) for the diagnosis of rheumatoid arthritis. 4) Subjects must have a diagnosis of RA less than or equal to 2 years. 5) Subjects must have high disease activity as defined by a tender joint count of at least 12, swollen joint count of at least 10, and a CRP of = .45 mg/dL or = 4.5 mg/L. 6) Subjects that are RF or anti-CCP positive. 7) Subjects must have evidence of erosion of the hands, wrists or feet on the screening radiograph. (To be read centrally) 8) Subjects must be methotrexate naive or their prior exposure must have been =10mg a week for not more than 3 weeks and no dose for 3 months prior to signing the informed consent. 9) Men and women (not nursing and not pregnant) = 18 years of age. Men and Women of childbearing potential are eligible if they are practicing effective contraceptive measures. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 48 hours prior to the start of study medication. Male subjects must be using an adequate method of contraception throughout the study including up to 10 weeks after the last infusion of abatacept so that the risk of pregnancy to their partner is minimized. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last infusion of abatacept. 2) Subjects who are impaired, incapacitated, or incapable of completing study related assessments. 3) Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous). 4) Subjects who have previously received treatment with an approved or investigational biologic RA therapy (infliximab, etanercept, anakinra, adalimumab). 5) Subjects with active vasculitis of a major organ system with the exception of rheumatoid nodules. 6) Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease, or other medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. 7) Female subjects, who have not had age and/or risk factor appropriate breast cancer screening or who have had a breast cancer screening study that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations (Please refer to Section 7.3.2). 8) Subjects with a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. 9) Subjects who have clinically significant drug or alcohol abuse. 10) Subjects with any serious acute bacterial infection (such as pneumonia or pyelonephritis) unless treated and completely resolved with antibiotics. 11) Subjects with severe chronic or recurrent bacterial infections (such as recurrent pneumonia, chronic bronchiectasis). 12) The following subjects are excluded from this study: - Subjects with current clinical or laboratory evidence of active or latent tuberculosis (TB). - Subjects with a history of active TB that was treated within the last 3 years. - Subjects with a history of active TB greater than 3 years ago unless there is documentation that the prior anti-TB treatment was appropriate in duration and type. 13) Subjects with herpes zoster that resolved less than 2 months prior to enrollment. 14) Subjects with evidence (as assessed by the investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV) infection. 15) Subjects with Hepatitis B surface antigen. 16) Subjects with Hepatitis C antibody-positive subjects who are also RIBA-positive or PCR-positive. 17) Subjects with any of the following laboratory values: - Hgb 2 times upper limit of normal. - Serum ALT or AST > 2 times upper
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The co-primary objectives for this study will compare the clinical efficacy of abatacept used in combination with methotrexate versus methotrexate alone on the following: 1) The proportion of subjects who achieve remission in 12 months of treatment (Day 365), as defined by a DAS 28 score less than 2.6 and 2) Joint damage progression measured by radiographic evaluation using the Genant-Modified Sharp total score at 12 months of treatment (Day 365). ; Secondary Objective: 1) Compare proportion of subjects with an ACR50 response at month 12 (Day 365). 2) Compare proportion of subjects achieving major clinical response defined by 6 months of consecutive ACR 70 response at month 12 (Day 365). 3) Compare disease activity as measured by DAS 28 score at month 12 (Day 365). 4) Compare improvement in physical function using the HAQ disability index at month 12 (Day 365) and assess improvement in physical function at month 24 (Day 729). 5) Compare inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, and joint space narrowing at month 12 (Day 365). 6) Assess inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, joint space narrowing and total score at month 24 (Day 729). 7) Determine safety and tolerability of abatacept in this subject population, including evaluation of immunogenicity of abatacept. ; Primary end point(s): Efficacy: Co-primary efficacy analysis include, in the order of sequential testing, comparisons between abatacept in combination with methotrexate and | — |
Countries
Austria, Belgium, Czech Republic, Germany, Ireland, Italy, Spain, United Kingdom
Outcome results
None listed