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

Sosei

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: AD 452

Study type

Interventional

Funder types

Industry

Identifiers

NCT00141934

P-AD452-022

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.