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Mentions "an encouraging preliminary study on the use of IV immunoglobulin in the postpartum period to help prevent relapses for women who are off their disease-modifying drug while breastfeeding."
"The increased relapse rate postpartum has led to the issue of prophylactic therapy. In a recent study, nine MS patients with 12 previous childbirthassociated relapses received prophylactic intravenous immune globulin (IVIg) postpartum. None went on to have clinical relapses.98 In another study, eight women who received prophylactic IVIg were compared with 18 untreated women. Ten patients in the untreated group relapsed postpartum, compared with only one patient in the treated group.99 There is a current postpartum IVIg prophylaxis trial being conducted by the PRIMS study group. One hundred patients
are being randomized to receive a 10- or 60-gram IVIg load within 24 hours of delivery, followed by 10 grams monthly for 6 months. Clinical parameters, with the focus on relapse rate, are being measured. This study is based on preliminary data generated from 50 patients who were treated with IVIg. They had 66percent fewer postpartum relapses than would have been predicted."
POPART'MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
This study is currently recruiting patients.
Verified by: Hospices Civils de Lyon August 2005
Sponsored by: Hospices Civils de Lyon
Information provided by: Hospices Civils de Lyon
Purpose
Multiple sclerosis (MS) affects 1 in 1000 people in western countries, mainly women in their childbearing years. It is an autoimmune disease of the central nervous system (CNS), which results in a chronic focal inflammatory response with subsequent demyelination and axonal loss. Recent prospective studies reported a significant decline by two-thirds in the rate of relapses during the third trimester of pregnancy and a significant increase by two-thirds during the first three months post-partum by comparison to the relapse rate observed during the year prior to the pregnancy (Confavreux et al., 1998). These dramatic changes in the relapse rate occur at a time when the impregnation of many substances (among which, sexual steroids) is at its highest, before a dramatic decline to the pre-pregnancy levels, immediately following delivery.
It may be hypothesized that sexual steroids could exert beneficial effects through a modulation of the immune state with a lowering of the pro-inflammatory lymphocyte responses of the Th1 type and an enhancement of the anti-inflammatory responses of the Th2 type. They may also play a direct role in the remyelination of central nervous system lesions, as they do in the peripheral nervous system. The POPART’MUS study is a European, multicentre, randomized, placebo-controlled and double-blind clinical trial, which aims to prevent MS relapses related to the post-partum condition, by administering high doses of progestin (nomegestrol acetate), in combination with endometrial protective doses of estradiol. Treatment will be given immediately after delivery and continuously during the first three months post-partum. Assuming the results of the trial to be positive, this new treatment could be considered in the relapsing-remitting phase of the disease in women afar from pregnancy and post-partum.
Drug: nomegestrol acetate
Drug: estradiol
Phase III
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title: POPART’MUS: Prevention of Post Partum Relapses With Progestin and Estradiol in Multiple Sclerosis
Further study details as provided by Hospices Civils de Lyon:
Primary Outcomes
To compare the rate of relapses during the first 12 weeks after delivery, between the treated and placebo groups
Secondary Outcomes
Percentage of patients who remain relapse-free during the 12-week period after delivery; Rate of relapses, percentage of patients who remain relapse-free during the 24-week period after delivery; Rate of relapses, percentage of patients who remain relapse-free during the 12- to 24-week period after delivery
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