MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-MASKED, PHASE IIIB STUDY TO COMPARE THE EFFICACY AND SAFETY OF ABATACEPT ADMINISTERED SUBCUTANEOUSLY AND ENDOVENOUSLY IN PATIENTS WITH RHEUMATOID ARTHRITIS, WHO RECEIVE METHOTREXATE AS MAINTENANCE THERAPY AND PRESENT INAPPROPRIATE CLINICAL RESPONSE TO METHOTREXATE.
- Conditions
- -M069M069
- Registration Number
- PER-016-08
- Lead Sponsor
- BRISTOL MYERS SQUIBB COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 206
• The patient is willing to participate in the study and sign the informed consent.
• Patients must meet the criteria of the American Association of Rheumatology (1987) for the diagnosis of rheumatoid arthritis and functional classes I, II or III of the American College of Rheumatology (1991).
• Patients must have had rheumatoid arthritis for more than 1 year from the time of the diagnosis.
• Patients with stable renal, endocrine, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease (eg, diabetes mellitus, congestive heart failure, chronic obstructive pulmonary disease) will be allowed to participate in This studio.
• Patients considered by the doctor or investigator to be inadequate responders to methotrexate. Patients should have taken methotrexate for at least 3 months at a minimum weekly dose of 15 mg, and at a stable dose for the 28 days prior to randomization (Day 1). A weekly dose of methotrexate of only 10 mg will be allowed in the case of patients who can not tolerate higher doses. In this circumstance, the weekly dose of 10 mg will be allowed if there is verifiable documentation in the medical file before entering the study indicating that the patient could not tolerate higher doses. The parenteral use of methotrexate is accepted according to clinical indication.
• Men and women who are at least 18 years of age.
• Informed consent must be signed before making any change in therapy for RA if those changes are solely for the purpose of the study.
• Women of childbearing age who are unwilling or unable to use a method of birth control that is acceptable throughout the study and for a period of up to 10 weeks after the last dose of the investigational product.
• Pregnant or lactating women.
• Women with a positive pregnancy test in the enrollment, or before the administration of the product under investigation.
• Patients who meet the diagnostic criteria for any other rheumatic disease (for example, lupus erythematosus).
• Patients with active vasculitis of a larger organic system (except for subcutaneous rheumatoid nodules).
• Patients with disabilities, disabilities, or who can not complete the study evaluations.
• Current symptoms of renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease that are severe, progressive or uncontrolled. Concomitant conditions that, in the opinion of the Investigator, would place the subject at an unacceptable risk if they participated in this study.
• Female patients who have had a screening for breast cancer that is suspected of neoplasia, and in whom the possibility of neoplasia can not be reasonably excluded after further clinical, laboratory or other diagnostic evaluations.
• Patients with a history of cancer in the last five years (less in the case of non-melanoma skin tumor cured with local resection). Existing non-melanoma skin tumors should be removed before treatment. The participation of patients with carcinoma in situ, treated with definitive surgical intervention is allowed.
• Patients who have a clinically significant history of alcohol or drug abuse.
• Patients with a severe acute bacterial infection (such as pneumonia or pyelonephritis, unless treated and completely treated with antibiotics).
• Patients with severe chronic or recurrent bacterial infections (such as recurrent pneumonia and chronic bronchiectasis).
• Patients at risk of tuberculosis (TB).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:proportion of patients that meet the ACR criteria of 20% improvement (ACR 20) after 6 months (Day 169).<br>Measure:Proportion of patients who meet the ACR criteria<br>Timepoints:6 months<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Proportion of patients meeting ACR 50 and ACR 70 after 6 months<br>Measure:Proportion of patients meeting ACR 50 and ACR 70 after 6 months<br>Timepoints:6 months<br>;<br>Outcome name:Response of the HAQ, the change in the HAQ and the DAS-28 scores.<br>Measure:Response of the HAQ, the change in the HAQ and the DAS-28 scores.<br>Timepoints:6 months<br>