Study record managers: refer to the Data Element Definitions if submitting registration or information. This was a multinational, multicenter, randomized, double-blind, 2-arm, parallel-dosing deed study.
The treatment period was 12 months. All participants continued their background therapy ies for rheumatoid arthritis RA non-biologic or biologic disease-modifying drugs [DMARDs], or combination throughout the double-blind treatment period. Double-blind study medication abatacept or placebo was administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses.
All participants who completed the month double-blind study period Day 1 through Daywere eligible to continue into the open-label period.
Participants continued to receive infusions every 28 days. Abatacept was administered intravenously IV on Days 1, 15, 29, and every 28 days thereafter, for a total turrtletown 14 doses.
P or normal saline [NS] for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, aadult a total of 14 doses. Participants also received background therapy ies for rheumatoid arthritis RA non-biologic or biologic disease-modifying drugs [DMARDs], or combination throughout the double-blind treatment period. AEs of special interest are those AEs that may be associated with the use of immunomodulatory drugs, including all infections, serious infections, and opportunistic infections; autoimmune disorders; neoplasms; acute infusional AEs pre-specified AEs occurring within 1 hour of start of infusion and peri-infusional AEs pre-specified AEs occurring within 24 hours of the start of infusion.
Vital s were measured at these visits before and after study medication infusion.
Vital measurements were performed for participants before and after infusion of study medication at each visit and included seated systolic blood pressure, seated diastolic blood pressure, temperature, and heart rate. Abnormalities were determined to be clinically ificant by the investigator.
Immunogenicity was defined as the presence of a positive anti-abatacept or anti-CTLA4 antibody. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information.
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The purpose of this clinical research study is to learn if abatacept is safe when co-administered with other approved rheumatoid arthritis medications. Detailed Description:. Drug Information available for: Abatacept.
FDA Resources. Arms and Interventions.
Concentrate and diluted in a solution, IV, 0 mg, Once daily, Day 1, 15, and Outcome Measures. Physical examinations were performed at the discretion of the investigator and included breast examinations for female participants. Serum samples from all treated adult participants with active rheumatoid arthritis were screened for the presence of drug-specific antibodies using ELISA. Eligibility Criteria.
Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Exclusion: Other auto-immune disease as a main diagnosis e. Contacts and Locations.
Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information. Publications automatically indexed to this study by ClinicalTrials. Abatacept used in combination with non-methotrexate disease-modifying antirheumatic drugs: a descriptive analysis of data from interventional trials and the real-world setting.
Arthritis Res Ther. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Rheumatoid Arthritis. Phase 3. Study Type :.
Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Actual Study Completion Date :.