A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.

Phase II Randomised, Double-Blind, Multicentre, Placebo-Controlled, Dose-Ranging, Parallel Group Study to Compare the Efficacy, Safety and Tolerability of 3 Strengths of AD 452 in Adults With Active RA Who Are Currently Taking Methotrexate.

AD 452 is a new drug which is being developed for use in adult patients with RA. It is believed that AD 452 may modify the underlying disease of RA as well as improving RA symptoms, and in order to establish its efficacy and safety, AD 452 is being tested in a 3 month study. Patients enrolled in this study will already be taking methotrexate for their RA and they will remain on methotrexate throughout the study. An earlier clinical study in 98 subjects with RA on stable background therapy investigated the pharmacokinetics, safety and tolerability of AD 452 taken for one month. The drug was well tolerated and no significant drug related adverse events were reported.

Rheumatoid Arthritis, RA, ACR20 endpoint, Tender/swollen joints, Improvement in pain, Health assessment questionnaire, Profile of mood states

Inclusion Criteria: Male/female age 18 -75 RA diagnosed for at least 6 months Taking methotrexate for at least 6 months Must have at least 4 swollen/tender joints Exclusion Criteria: Must not be pregnant/breastfeeding Must not have history of other inflammatory disorders Other conditions may lead to exclusion from the trial (e.g. Diabetes mellitus, malignant melanoma, HIV, active infection, hepatitis B/C, cardiac conduction disorders, hepatic/renal insufficiency, active depression/anxiety/psychosis/schizophrenia or convulsions.