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.
1 other identifier
interventional
232
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 rheumatoid-arthritis
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedApril 5, 2007
April 1, 2007
August 31, 2005
April 4, 2007
Conditions
Keywords
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Soseilead
Study Sites (10)
Clinical Research of West Florida, Inc
Clearwater, Florida, 33765, United States
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, 33334, United States
Ocala Rheumatology Research Center
Ocala, Florida, 34474, United States
Sarasota Arthritis Research Center
Sarasota, Florida, 34239, United States
Advent Clinical Research Centers, Inc.
St. Petersburg, Florida, 33703, United States
Dept of Rheumatology, Columbia Medical Practice
Columbia, Maryland, 21045, United States
Anderson and Collins Clinical Research, Inc.
Edison, New Jersey, 08817, United States
Station Avenue
Haddon Heights, New Jersey, 08035, United States
Atlantic Coast Research LLC
Toms River, New Jersey, 08755, United States
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
August 1, 2005
Last Updated
April 5, 2007
Record last verified: 2007-04