Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
immune globulin
Maladies Auto-immunes+11
+ Maladies démyélinisantes
+ Maladies du Système Immunitaire
Étude thérapeutique
Résumé
Date de début de l'étude : 1 février 1993
Date à laquelle le premier participant a commencé l'étude.PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are treated with intravenous immune globulin or placebo. In the absence of a hypersensitivity reaction to a test dose, a total of 11 doses is administered: daily for 5 days, then every 2 weeks for 12 weeks. Patients are followed at 3 months.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.76 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 60 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Clinically or laboratory-supported definite multiple sclerosis Disease relapsing-remitting or relapsing-progressive (i.e., secondary- progressive) Targeted neurologic deficit as follows: 25% or more loss of power in at least 1 limb Severity -1 or greater on Mayo Clinic rating scale OR Between 3+/5 and 4-/5 on Medical Research Clinic muscle power scale Documented by Mayo Clinic Department of Neurology as neither progressing nor improving for 4 to 18 months prior to entry No clinical evidence of spontaneous or corticosteroid-induced improvement Able to cooperate with isometric strength testing requirements --Prior/Concurrent Therapy-- No concurrent experimental drug therapy No concurrent intravenous immune globulin At least 3 months since immunosuppressive therapy, e.g., corticosteroids and corticotropin At least 3 months since plasma exchange --Patient Characteristics-- Hepatic: No coagulation defect, e.g., hyperviscosity syndrome Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No unstable or advanced ischemic or cerebrovascular disease, e.g.: angina congestive heart failure transient ischemic attack stroke Immunologic: No human gamma globulin or albumin sensitivity No hypergammaglobulinemia No known antibody deficiency syndrome, especially IgA deficiency Other: No condition interfering with neurologic exam, e.g.: Major amputation Deforming arthritis Major psychiatric illness Superimposed lower motor neuron deficit No intellectual impairment precluding study participation No pregnant or nursing women Adequate contraception required of fertile patients