A randomized, double-blind, placebo-controlled study of CD4 monoclonal antibody therapy in early rheumatoid arthritis.
OBJECTIVE
To assess the efficacy of the CD4 monoclonal antibody (MAb) cM-T412 in the treatment of early rheumatoid arthritis (RA).


METHODS
Sixty patients were enrolled in a 6-week randomized, double-blind, placebo-controlled study investigating multiple dose regimens of cM-T412. Thirty patients subsequently were enrolled in a 9-month randomized, double-blind, placebo-controlled study investigating monthly single-dose administrations of cM-T412.


RESULTS
Analysis of clinical parameters revealed no changes in arthritis activity in the groups that received CD4 MAb or the placebo group, and no difference between the groups, in either in the first or the second part of the study. The number of circulating CD4+ cells decreased substantially in the patients treated with CD4 MAb.


CONCLUSIONS
CD4 MAb treatment of patients with early RA induced no therapeutic effect.
van der Lubbe
P A
PA
University Hospital, Department of Rheumatology, Leiden, The Netherlands.
Dijkmans
B A
BA
Markusse
H M
HM
Nässander
U
U
Breedveld
F C
FC
D000293:Adolescent; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000276:immunology / Q000628:therapy*; D001772:Blood Cell Count; D015704:CD4 Antigens / Q000276:immunology*; D015496:CD4-Positive T-Lymphocytes / Q000166:cytology; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010919:Placebos; D013997:Time Factors
D000911:Antibodies, Monoclonal; D015704:CD4 Antigens; D010919:Placebos