A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00141934
- Lead Sponsor
- Sosei
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 232
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Clinical Research of West Florida, Inc
🇺🇸Clearwater, Florida, United States
Sarasota Arthritis Research Center
🇺🇸Sarasota, Florida, United States
Dept of Rheumatology, Columbia Medical Practice
🇺🇸Columbia, Maryland, United States
Station Avenue
🇺🇸Haddon Heights, New Jersey, United States
Advent Clinical Research Centers, Inc.
🇺🇸St. Petersburg, Florida, United States
Center for Rheumatology, Immunology and Arthritis
🇺🇸Fort Lauderdale, Florida, United States
Rheumatic Disease Associates
🇺🇸Willow Grove, Pennsylvania, United States
Ocala Rheumatology Research Center
🇺🇸Ocala, Florida, United States
Atlantic Coast Research LLC
🇺🇸Toms River, New Jersey, United States
Anderson and Collins Clinical Research, Inc.
🇺🇸Edison, New Jersey, United States