Abstract

To document the long-term safety profile of MMF 1g bid in patients with rheumatoid arthritis. This study is a follow up study to SPID# 0360. Mycophenolate mofetil (RS 61443) (MMF) is an immunosuppressant that reversibly inhibits the proliferative response of human peripheral mononuclear cells to T and B cell mitogens in Vitro, and immunoglobulin formation by human B cells in response to polyclonal stimulators. These properties make MMF a good candidate for use in patients with rheumatoid arthritis (RA). Phase I and II data indicated that optimum effect and safety were achieved at a MMF dose of 1 g BID in patients with RA. The Study is an extension of the """"""""double-blind, randomized, parallel group, multicenter comparison of the efficacy and safety of mycophenolate mofetil and placebo in patients with active rheumatoid arthritis"""""""" (asscession #97-7174). The design in an open-label trial of MMF therapy in RA for a minimum of 6 months and will have a duration of approximately 1 year, evaluating the long-term safety profile. Seven patients are anticipated at Massachusetts General Hospital to continue into this extension study.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR001066-22S3
Application #
6265456
Study Section
Project Start
1998-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
22
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
Massachusetts General Hospital
Department
Type
DUNS #
City
Boston
State
MA
Country
United States
Zip Code
02199

  Publications

Schorr, Melanie; Dichtel, Laura E; Gerweck, Anu V et al. (2018) Sex differences in body composition and association with cardiometabolic risk. Biol Sex Differ 9:28
Srinivasan, Shylaja; Kaur, Varinderpal; Chamarthi, Bindu et al. (2018) TCF7L2 Genetic Variation Augments Incretin Resistance and Influences Response to a Sulfonylurea and Metformin: The Study to Understand the Genetics of the Acute Response to Metformin and Glipizide in Humans (SUGAR-MGH). Diabetes Care 41:554-561
Kelsey, Megan M; Braffett, Barbara H; Geffner, Mitchell E et al. (2018) Menstrual Dysfunction in Girls From the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study. J Clin Endocrinol Metab 103:2309-2318
Kleinberger, Jeffrey W; Copeland, Kenneth C; Gandica, Rachelle G et al. (2018) Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial. Genet Med 20:583-590
Fourman, Lindsay T; Czerwonka, Natalia; Shaikh, Sofia D et al. (2018) Insulin-like growth factor 1 inversely relates to monocyte/macrophage activation markers in HIV. AIDS 32:927-932
Berkowitz, Robert I; Marcus, Marsha D; Anderson, Barbara J et al. (2018) Adherence to a lifestyle program for youth with type 2 diabetes and its association with treatment outcome in the TODAY clinical trial. Pediatr Diabetes 19:191-198
Arslanian, Silva; El Ghormli, Laure; Kim, Joon Young et al. (2018) The Shape of the Glucose Response Curve During an Oral Glucose Tolerance Test: Forerunner of Heightened Glycemic Failure Rates and Accelerated Decline in ?-Cell Function in TODAY. Diabetes Care :
Kriska, Andrea; El Ghormli, Laure; Copeland, Kenneth C et al. (2018) Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes. Pediatr Diabetes 19:36-44
Venditti, E M; Tan, K; Chang, N et al. (2018) Barriers and strategies for oral medication adherence among children and adolescents with Type 2 diabetes. Diabetes Res Clin Pract 139:24-31
Foldyna, Borek; Fourman, Lindsay T; Lu, Michael T et al. (2018) Sex Differences in Subclinical Coronary Atherosclerotic Plaque Among Individuals With HIV on Antiretroviral Therapy. J Acquir Immune Defic Syndr 78:421-428

Showing the most recent 10 out of 945 publications