- Sunstone: A long-term safety study of rituximab in patients with rheumatoid arthritis refractory to anti-TNF therapy.
The Sunstone study is an observational study which will last for the duration of 5 years. This study will follow RA patients who has had inadequate responses to anti-TNF therapy and who will also receive Rituxan. Data will be collected every 6 months from the patients’ medical records and captured on an electronic data collection system.
- SUNDIAL: An Open-Label, Prospective study of the safety of Rituxamab in Combination with other Disease-Modifying Anti-Rheumatic Drugs in Subjects with Active Rheumatoid Arthritis
- BLyS 1056: A phase 3, multicenter randomized, doubleblind, placebo-controlled 76-week study to evaluate the efficacy and safety of belimumab (HGS1006-LymphoStat-B) a fully human monoclonal anti-Blys antibody in subjects with systemic Lupus Eythematosus
This is phase 3 study for belimumab which includes 2 double-blind, placebo-controlled, phase 3 trials to evaluate the efficacy and safety of belimumab plus standard of care, versus placebo plus standard of care in SLE patients for a duration of 76-weeks. Patients were dosed on Day 0, 14 and 28, then every 28 days thereafter for the duration of the study.
- BLyS 1066: A multi-center study is complete continuation Trial of Belimumab(HGS1006, Lymphostat-B) a fully Human Monoclonal Anti-Blys Antibody, in Subjects with Systetmic Lupus Erythematosus(SLE) who completed the Phase Protocol HGS 1006-C1056 in the United States.
- CORRONA: Consortium of Rheumatology Researchers of North America Data Collection Program is a data collection program which collects data from Rheumatoid Arthritis, Psoriatic Arthritis and Undifferentiated Arthritis patients and their physicians. Data is collected and documented on the effectiveness, safety and patterns of use of DMARDs, NSAIDS, biologics and any other treatment that is currently being used in the management of Rheumatoid Arthritis, Psoriatic Arthritis and Undifferentiated Arthritis. Corrona's mission is to advance rheumatology research and to improve the quality of rheumatology patient care.
There is an initial baseline visit and patients are followed every 4months for the Rheuamtoid Arthritis patients and every 6 months for the Psoriatic Arthritis patients.
- Lupus Cohort: A longitudinal registry started by the rheumatology division in 2002 to investigate elements in the blood and urine of Lupus patients and to assess their roles in causing and /or affecting the disease. We are also analyzing these samples for markers to eventually learn how to treat the patients with better results and less risk.
- SisSLE (Sisters of Women with Systemic Lupus Erythematosus): The Feinstein Institute Medical Research has started a new research study looking for sisters: one with a diagnosis of systemic lupus erythematosus (SLE), and one (or more) who does not have lupus. The primary goal of the study is to understand how individuals may progress to lupus. By following sister(s) of a lupus patient the hope is to identify the disease in its earliest, pre-symptomatic stage and track its progression over time. The pilot study will enroll 400 sisters over a 2-year period.
- TEVA-Lupus Arthritis (Dr. Irene Blanco): Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Biomarkers and Clinical Effect of Laquinimod in Systemic Lupus Erythematosus Patients with Active Lupus Arthritis. Objectives of the study are to evaluate the safety and tolerability of 2 doses of Laquinimod (0.5mg and 1mg/day) in SLE patients with active Lupus Arthritis, and to evaluate biomarkers and clinical effect of 2 doses of laquinimod in SLE patients with active Lupus Arthritis. Study is about 5 months.
- ABBOTT-Rheumatoid Arthritis (Dr. Clement Tagoe): A Double-Blind, Randomized, Parallel-Arm, Multi-Center Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy with Adalimumab in Subjects with Early Rheumatoid Arthritis. The objective of this study is to assess and to compare the proportion of subjects who achieve low regimens of MTX in combination with adalimumab in order to determine the dose-response pattern of MTX in patients with early rheumatoid arthritis. The study is also designed to evaluate the pharmacokinetics and safety of MTX and adalimumab in combination therapy. Closed to recruitment.
- ABBOTT-Rheumatoid Arthritis (Dr. Clement Tagoe): A Multicenter, Double-Blind, Randomized, Parallel-Arm Study to Determine the Effect of Methotrexate Dose on Clinical Outcome and Sonographic Signs in Patients with Moderate to Severely Active Rheumatoid Arthritis Treated with Adalimumab. The objective of this study is to test for non-inferiority of low-dose MTX plus adalimumab clinical efficacy as compared to high-dose MTX plus adalimumab, using the mean DAS28(CRP) score in each Arm at Week 24 as the primary endpoint.
Subjects must be biologic-naïve rheumatoid arthritis (RA) patients with moderate to severe disease activity [DAS28(CRP) > 3.2] on a stable dose of oral MTX 15, 17.5, or 20 mg q week for at least 12 weeks.
- BIOGEN-Tweak (Dr. Chaim Putterman): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of BIIB023 in Subjects With Lupus Nephritis. The primary objective of the study is to assess the efficacy of BIIB023 as an add-on treatment to background therapy compared with placebo in combination with background therapy in the treatment of subjects with active, biopsy-proven LN. Secondary objectives of this study are to assess the safety and tolerability of BIIB023 compared with placebo in this study population
- MEDIMMUNE-MEDI-546 (Dr. Chaim Putterman): A Phase 2, Randomized Study to Evaluate the Efficacy and Safety of MEDI-546 in Subjects with Systemic Lupus Erythematosus. The primary objective of this study is to evaluate the efficacy of MEDI-546 compared to placebo in subjects with chronic, moderately-to-severely active systemic lupus erythematosus (SLE) with an inadequate response to standard of care treatment for SLE (SOC SLE) at Day 169 (Week 24).
Nicole C. Jordan, BSc, MA
Clinical Research Coordinator
Fax: (718) 515-6103