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

Completed · Phase 2

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00141934

Run by

Sosei

People needed

232

Starts

2005-08-01

Last updated by the study team

2007-04-05

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Clinical Research of West Florida, Inc — Clearwater, Florida, United States
• Center for Rheumatology, Immunology and Arthritis — Fort Lauderdale, Florida, United States
• Ocala Rheumatology Research Center — Ocala, Florida, United States
• Sarasota Arthritis Research Center — Sarasota, Florida, United States
• Advent Clinical Research Centers, Inc. — St. Petersburg, Florida, United States
• Dept of Rheumatology, Columbia Medical Practice — Columbia, Maryland, United States
• Anderson and Collins Clinical Research, Inc. — Edison, New Jersey, United States
• Station Avenue — Haddon Heights, New Jersey, United States
• Atlantic Coast Research LLC — Toms River, New Jersey, United States
• Rheumatic Disease Associates — Willow Grove, Pennsylvania, United States

Full record on ClinicalTrials.gov

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