a t i s t i c s and Epidemiology, Mayo C l i n i c
I n t r o d u c t i o n We a r e c o n d u c t i n g a p r o s p e c t i v e b l i n d e d t r i a l of lymphapheresis i n e a r l y rheumatoid a r t h r i t i s i n o r d e r t o d e t e r m i n e whether t h i s procedure i s e f f e c t i v e .I n s t r u c t u r i n g t h i s s t u d y we t h e o r i z e d t h a t t h e b e s t chance t o show a measurable b e n e f i c i a l e f f e c t would be i n e a r l y , b u t d e f i n i t e d i s e a s e . T h i s i s a r e p o r t of t h e f i r s t 15 p a t i e n t s i n t h i s ongoing t r i a l . P a t i e n t s , Materials and Methods P a t i e n t s f o r t h i s double b l i n d p r o s p e c t i v e t r i a l were a s s i g n e d randomly t o r e c e i v e e i t h e r a t r u e o r sham lymphapheresis regimen. To be a c c e p t e d i n t o t h e t r i a l , each p a t i e n t had t o s a t i s f y t h e f o l l o w i n g c r i t e r i a : a t l e a s t 18 y e a r s o l d ; d e f i n i t e o r c l a s s i c rheumatoid a r t h r i t i s by ARA c r i t e r i a ; rheumatoid f a c t o r p o s i t i v e ; d i s e a s e d u r a t i o n g r e a t e r t h a n or e q u a l t o s i x months b u t less t h a n 18 months; a t l e a s t s i x s w o l l e n j o i n t s ; on a s p i r i n o r n o n s t e r o i d a l a n t i -i n f l a m m a t o r y drug f o r g r e a t e r t h a n t h r e e months ; never t r e a t e d w i t h g o l d , a n t i -m a l a r i a l s , d -p e n i c i l l a m i n e , immunosuppressives o r p r e d n i s o n e . P a t i e n t s were excluded i f t h e y had an i n f e c t i o n o r a n o t h e r s e r i o u s i l l n e s s , were p s y c h o l o g i c a l l y u n s u i t a b l e o r u n a b l e t o r e t u r n f o r t h e f u l l t r e a t m e n t program. C l i n i c a l a s s e s s m e n t s were made a t e n t r y i n t o t h e s t u d y , a f t e r the l a s t a p h e r e s i s and a g a i n s i x weeks l a t e r , i.e. a t 0 , 6 and 12 weeks.The f o l l o w i n g c l i n i c a l and l a b o r a t o r y d e t e r m i n a t i o n s were used t o assess d i s e a s e a c t i v i t y a t t h e s e i n t e r v a l s : p a t i e n t ' s s u b j e c t i v e p a i n s c o r e based on -10 e q u a l s " t e r r i b l e " p a i n , t o +10 e q u a l s r e m i s s i o n ; time in minutes t o e a s i n g of morning s t i f f n e s s ;
time i n seconds t o walk 50 f e e t ; g r i p s t r e n g t h s i n mm of mercury, a v e r a g i n g two d e t e r m i n a t i o n s on each hand; j o i n t c o u n t , i . e . t o t a l number of s w o l l e n j o i n t s p l u s t o t a l number of t e n d e r j o i n t s ; e r y t h r o c y t e s e d i m e n t a t i o n r a t e i n mm p e r hour by t h e Westergren method; rheumatoid f a c t o r t i t e r s by t h e l a t e x f i x a t i o n method.165 lymphapheresis p r o c e d u r e s performed on t h e 15 p a t i e n t s , 88 were sham lymphapheresis (SLP) and 77 t r u e lymphapheresis (TLP), Lymphapheresis was performed w i t h an IBM 2997 Blood C e l l S e p a r a...
