Nonathymulin in rheumatoid arthritis: two double blind, placebo controlled trials.
Two randomised double blind, placebo controlled trials have been carried out to assess the effectiveness of nonathymulin, a synthetic thymic peptide hormone, in the treatment of rheumatoid arthritis (RA) and to compare three different dosage schedules (1, 5, and 10 mg/day). Nonathymulin 5 mg proved to be the most efficient dose, providing significant clinical improvement as evaluated by the global assessment of all patients who entered the trials (56% v 17% in the placebo group) (p less than 0.02) and by four objective parameters. This effect was accompanied with minimal adverse effects and was not associated with clear changes in immunological parameters. A significant correlation was observed, however, in clinical response to nonathymulin, and T cell subset imbalance was assessed using monoclonal anti-T cell antibodies and a functional suppressor T cell assay.
Amor
B
B
Department of Rheumatology, Cochin Hospital, Paris, France.
Dougados
M
M
Mery
C
C
Dardenne
M
M
Bach
J F
JF
D001172:Arthritis, Rheumatoid / Q000188:drug therapy* / Q000276:immunology; D002986:Clinical Trials as Topic; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D011897:Random Allocation; D013935:Thymic Factor, Circulating / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013951:Thymus Hormones / Q000627:therapeutic use*
D013951:Thymus Hormones; D013935:Thymic Factor, Circulating