Rheumatoid Arthritis, NOS
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects must have a diagnosis of UA. A subject with UA should have symptomatic clinical synovitis of two or more joints and should possess at least one and not more than three of the criteria for classification of RA of the American Rheumatism Association (1987). See Appendices 1 and 2of the protocol. 2) Subjects must not meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous). 3) The subject’s disease duration [defined as the time from the onset of symptoms (joint pain, swelling, or stiffness) of arthritis to enrollment] must be less than 18 months. 4) Subjects must have be positive for autoantibodies against cyclic citrullinated peptides by ELISA. 5) Men and women, at least 18 years old. WOCBP are eligible if they are practicing effective contraceptive measures. WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 10 weeks after the last infusion of abatacept in such a manner that the risk of pregnancy 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) Women who are pregnant or breastfeeding or with a positive pregnancy test on enrollment or prior to study drug administration. 3) Subjects who are impaired, incapacitated, or incapable of completing study related assessments. 4) Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous). 5) Undifferentiated Arthritis duration of greater than 18 months. 6) Subjects who have previously received treatment with an approved biologic RA therapy (infliximab, etanercept, anakinra, adalimumab). 7) Subjects with active vasculitis of a major organ system. 8) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological, or cerebral disease. Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study. 9) Female subjects, who have not had age and/or risk factor appropriate breast cancer screening (as defined by published guidelines and/or local standards endorsed by the national cancer or medical society and/or the Ministry of Health), 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). 10) 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. 11) Subjects who have clinically significant drug or alcohol abuse. 12) Subjects with any serious acute bacterial infection (such as pneumonia or pyelonephritis unless treated and completely resolved with antibiotics). 13) Subjects with severe chronic or recurrent bacterial infections (such as recurrent pneumonia, chronic bronchiectasis). 14) Subjects with active tuberculosis (TB) requiring treatment within the previous 3 years. Subjects with a positive PPD at screening will not be eligible for the study unless active TB infection has been ruled out, and they have a negative chest x-ray at enrollment. A PPD response that is equal to or greater than 10 mm should be considered a positive test, although a lower threshold (5 mm) may be applied as determined by the clinical circumstance and investigator according to published guidelines and/or local standards endorsed by the medical society. (Section 7.3.2) 15) Subjects with herpes zoster that resolved less than 2 months prior to enrollment. 16) 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. 17) Subjects who have at any time received treatment with CTLA4Ig, or abatacept. 18) Subjects who have received treatment with any investigational drug within 28 days(or less than 5 terminal half-lives of elimination) of the Day 1 dose. 19) Subjects currently receiving treatment with immunoadsorption columns (such as Prosorba columns), mycophenolate mofetil (CellCept), cyclosporine, D-Penicillamine, or calcineurin inhibitors. 20) Treatment with a DMARD prior to enrollment in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the proportion of subjects with UA who develop RA as defined by 1987 ARA criteria one year after the start of blinded study medication.;Secondary Objective: To assess : 1) Proportion of subjects with UA who develop RA as defined by 1987 ARA criteria 2 years after the start of blinded study medication. 2) Proportion of subjects with UA who develop either RA by 1987 ARA criteria or another rheumatic disease at 12 & 24 months. 3) Degree of synovitis and structural joint damage of the hands (carpal and MCP joints) at 6, 12 & 24 months after the start of study therapy between the 2 treatment groups using MRI imaging. 4) Proportion of subjects with persistent symptomatic clinical synovitis at 6, 12 & 24 months after the start of medication between the 2 treatment groups & also subjects with a full DAS score of <1.6 at 6,12 & 24 months. 5) Pharmacodynamic effect of abatacept on serum levels of autoantibodies. 6) Disease activity over time between the treatment groups using the mean values of the DAS28-CRP score. 7) Proportion of subjects with a DAS28-CRP score of <2.6 at 6, 12 & 24 months. See protocol for additional secondary objectives.;Primary end point(s): The primary outcome of the study will be the proportion of subjects with a diagnosis of RA by 1987 ARA criteria at 12 months. Secondary efficacy outcome measures include the proportion of subjects with a diagnosis of RA by 1987 ARA criteria at 24 months, the proportion of subjects who develop either RA by 1987 ARA criteria or another rheumatic disease at 12 and 24 months, the proportion of subjects with persistent symptomatic clinical synovitis at 6, 12, and 24 months, the mean DAS28-CRP score at 6, 12, and 24 months, the proportion of subjects with a DAS28-CRP score of <2.6 at 6, 12, and 24 months, titers of RA-related autoantibodies, and inflammation and structural damage (degree of synovitis, erosions and joint space narrowing) on MRI using a centralized reader blinded to sequence and t | — |
Countries
Belgium, Germany, Italy, Spain, United Kingdom
Outcome results
None listed