None listed
Conditions
Interventions
Group 1 Type of group
Abatacept 125 mg per week via SC injection, without IV loading dose, with base MTX, for 24 months
Group name:Group 2 Type of group
Adalimumab 40 mg in alternate weeks via SC injection. with base MTX, for 24 months,
Sponsors
BRISTOL MYERS SQUIBB COMPANY,
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Before performing any study procedure, the subjects (or their legal representative) will be explained the details of the study and will be given the written informed consent document to read. Then, if the subjects agree to participate in the study, they will express their consent by signing and dating the informed consent document in the presence of the study staff. • Adult men and women with active, moderate to severe RA, diagnosed according to the ACR criteria (Annexes 3 and 4), who have not responded to MTX therapy and have not previously received biological therapy with DMARD to treat RA . • Subjects must have a confirmed diagnosis of RA of 3.2 in the selection. • Subjects must have laboratory findings supporting the diagnosis of RA • Subjects must be willing to self-inject or have someone to treat them and inject the medication. • Subjects must be able to follow the study visit scheme and must understand and meet other protocol requirements. • Men and women> 18 years old.
Exclusion criteria
Exclusion criteria: • Women who may potentially become pregnant and who are unwilling or unable to use an acceptable safe method to prevent pregnancy throughout the study period and up to 10 weeks after the last dose of the product under investigation. • Women who are pregnant or breastfeeding. • Women with a positive pregnancy test during enrollment or before administration of the product under investigation. • Any previous or current medical condition that makes the use of TNF blocking agents dangerous; demyelinating disorders of the central nervous system, congestive heart failure (Class III or Class IV of the New York Heart Association [NYHA]) (Annex 5), lupus-like syndrome. • History of active or chronic hepatitis B (defined as the persistence of hepatitis B surface antigens for more than 6 months) or active hepatitis C virus infection. • Subjects that meet diagnostic criteria for any other rheumatic disease (eg, lupus erythematosus). • Subjects with a history of cancer within the previous 5 years, other than non-melanoma skin cancer cured by local resection. The nonmelanoma skin cancer present must be removed before administration of the product under investigation. Subjects with carcinoma in situ, treated with definitive surgical intervention before entering the study, can participate in it. • Subjects with active vasculitis in a major organic system (except subcutaneous rheumatoid nodules) • Subjects who have previously received treatment with a biological product under investigation for RA or approved biological therapy for RA (eg, abatacept, adalimumab, anakinra, etanercept, infliximab or rituximab). • Invalid, disabled or unable subjects to complete the evaluations related to the study. • Current symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease. Concomitant medical conditions that, in the opinion of the investigator, may place the subject in an unacceptable risk situation when participating in this study. • Alcoholism or addiction to clinically significant illicit drugs. • Subjects with any serious acute bacterial infection (such as pneumonia or pyelonephritis, unless it had been treated and resolved completely with antibiotics.) • Subjects with severe or recurrent chronic bacterial infections (such as recurrent pneumonia or chronic bronchiectasis) • Subjects at risk of tuberculosis. • Subjects with herpes zoster resolved less than 2 months before enrollment. • Subjects with evidence (according to the investigator´s evaluation) of active or latent bacterial or viral infections at the time of potential enrollment, which includes subjects with evidence of human immunodeficiency virus (HIV) infection. • Subjects with surface antigen for hepatitis B positive. • Subjects with antibodies positive for hepatitis C that are also RIBA positive or PCR-positive.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The proportion of subjects that meet the ACR criterion of 20% improvement (ACR20) after 12 months of treatment (Day 365). Measure:Proportion of subjects that meet the ACR criteria for a 20% improvement (ACR20) Timepoints:12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The comparative safety profile of 12 months (Day 365) and 24 months (729) of treatment with abatacept versas adalimumab, estimated by the rate of EAS, severe infections and pre-specified opportunistic infections (pneumonia, tuberculosis, herpes zoster, various combined port infections and all hospital infections) Measure:12 month comparative security profile Timepoints:12 months (Day 365) and 24 months (729) ; Outcome name:The effect at radiographic level of 12 months (Day 365) and 24 months (Day 729) of treatment with abatacept versus adalimumab estimated by the slab of absence of progressions since the baseline evaluation and based on the smallest detectable difference in joint damage by evaluation radiographic using Sharps total scale modified by van der Heijde Measure:Effect at radiographic level of 12 months (Day 365) and 24 months (Day 729) Timepoints:12 months (Day 365) and 24 months (Day 729) ; Outcome name:The comparative retention profile of 12 months (Day 365) and 24 months (Day 729) of treatment with abatacept versus adalimumab, estimated by the discontinuation rate for any cause Measure:Comparative retention profile of 12 months (Day 365) and 24 months (Day 729) Timepoints:12 months (Day 365) and 24 months (Day 729) ; Outcome name:The comparative tolerability at 12 months (Day 365) and 24 months (Day 729) of treatment with abatacept versus adalimumab estimated by the rate of registered at the injection site and the induction of autoantibodies. Measure:Comparative tolerability at 12 months (Day 365) and 24 months (Day 729) Timepoints:12 months (Day 365) and 24 months (Day 729) | — |
Contacts
Public ContactElizabeth Beatriz Rospigliosi
BRISTOL MYERS SQUIBB PERU S.A.
Outcome results
None listed