Abstract

This phase II, multi-national, double-blind, placebo-controlled, parallel group study will assess the safety and potential of CDP571 in treating patients with moderate to severe Crohn's disease following an IV dose of 20 or 10 mg/kg of CDP571 followed by 8- or 12- weekly dosing with 10 mg/kg CDP571 over 24 weeks. Subjects will be monitored throughout for safety. Primary efficacy endpoint is the percentage of patients who show a response to treatment (a decrease in CDAI >/= 70 points) at 2 weeks.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000055-39
Application #
6304558
Study Section
Project Start
1999-12-01
Project End
2001-02-28
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
39
Fiscal Year
2000
Total Cost
$32,779
Indirect Cost

  Institution

Name
University of Chicago
Department
Type
DUNS #
225410919
City
Chicago
State
IL
Country
United States
Zip Code
60637

  Publications

Rosenfield, Robert L; Ehrmann, David A (2016) The Pathogenesis of Polycystic Ovary Syndrome (PCOS): The Hypothesis of PCOS as Functional Ovarian Hyperandrogenism Revisited. Endocr Rev 37:467-520
Garyu, Justin W; Meffre, Eric; Cotsapas, Chris et al. (2016) Progress and challenges for treating Type 1 diabetes. J Autoimmun 71:1-9
Rosenfield, Robert L (2015) The Polycystic Ovary Morphology-Polycystic Ovary Syndrome Spectrum. J Pediatr Adolesc Gynecol 28:412-9
Maitland, Michael L; Xu, Chun-Fang; Cheng, Yu-Ching et al. (2015) Identification of a variant in KDR associated with serum VEGFR2 and pharmacodynamics of Pazopanib. Clin Cancer Res 21:365-72
Bershad, Anya K; Jaffe, Jerome H; Childs, Emma et al. (2015) Opioid partial agonist buprenorphine dampens responses to psychosocial stress in humans. Psychoneuroendocrinology 52:281-8
Fleming, Gini F; Schumm, Philip; Friberg, Greg et al. (2015) Circadian variation in plasma 5-fluorouracil concentrations during a 24 hour constant-rate infusion. BMC Cancer 15:69
Kirkpatrick, Matthew G; Francis, Sunday M; Lee, Royce et al. (2014) Plasma oxytocin concentrations following MDMA or intranasal oxytocin in humans. Psychoneuroendocrinology 46:23-31
Copinschi, Georges; Leproult, Rachel; Spiegel, Karine (2014) The important role of sleep in metabolism. Front Horm Res 42:59-72
Müller, Peter; Quintana, Fernando A; Rosner, Gary L et al. (2014) Bayesian inference for longitudinal data with non-parametric treatment effects. Biostatistics 15:341-52
Refetoff, Samuel; Bassett, J H Duncan; Beck-Peccoz, Paolo et al. (2014) Classification and proposed nomenclature for inherited defects of thyroid hormone action, cell transport, and metabolism. Thyroid 24:407-9

Showing the most recent 10 out of 244 publications