REMICADE(R) Study Results Show Greater Steroid-Free Remission and Mucosal ... Melodika.net (press release)
SONIC was a multicenter, Phase 4, randomized, double-blind, controlled clinical trial designed to compare the efficacy and safety of REMICADE monotherapy, azathioprine monotherapy and combination therapy with the 2 drugs in patients with moderately to severely active Crohn's disease who were naive to immunomodulator and biologic therapy. A total of 508 patients from the U.S., Europe and Israel were enrolled in the study and were randomized into three groups; 170 patients received azathioprine less than or equal to 2.5 mg/kg/day and placebo infusions, 169 patients received REMICADE 5 mg/kg infusions at weeks 0, 2, 6 and every 8 weeks thereafter with placebo capsules and 169 patients received REMICADE 5 mg/kg at weeks 0, 2, 6 and every 8 weeks thereafter and azathioprine less than or equal to 2.5 mg/kg/day. The primary endpoint of SONIC was to assess the induction of steroid-free remission at week 26. Fifty-two percent of patients enrolled in SONIC were male and patients had a median age of 34-years-old, median weight of 70 kg, median disease duration of 2.3 years and median baseline Crohn's Disease Activity Index (CDAI) score of 275. Patients completing treatment through week 30, and who, in the opinion of the investigator, may benefit from continued treatment, entered into the study extension beginning at week 30 through week 50.
Rocklin and Roseville TodayThe Forgotten Hormone; Weight Gain, Loss of Libido, Osteoporosis Dietary Phytoestrogens and Cancer: In Vitro and In Vivo Studies. Journal of Steroid Biochemistry and Molecular Biology 41:3-8 (1992) 331-337 Leary, Warren E. 1995. Progesterone may play a major role in the prevention of nerve disease.
