A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects. - Full Text View

Sponsored by:	Sosei
Information provided by:	Sosei
ClinicalTrials.gov Identifier:	NCT00141934

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: AD 452	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Further study details as provided by Sosei:

Estimated Enrollment:	232
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141934

Locations

United States, Florida
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States, 33334
Clinical Research of West Florida, Inc
Clearwater, Florida, United States, 33765
Ocala Rheumatology Research Center
Ocala, Florida, United States, 34474
Advent Clinical Research Centers, Inc.
St. Petersburg, Florida, United States, 33703
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239
United States, Maryland
Dept of Rheumatology, Columbia Medical Practice
Columbia, Maryland, United States, 21045
United States, New Jersey
Anderson and Collins Clinical Research, Inc.
Edison, New Jersey, United States, 08817
Atlantic Coast Research LLC
Toms River, New Jersey, United States, 08755
Station Avenue
Haddon Heights, New Jersey, United States, 08035
United States, Pennsylvania
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States, 19090

Sponsors and Collaborators

Sosei

More Information

Study ID Numbers:	P-AD452-022
Study First Received:	August 31, 2005
Last Updated:	April 4, 2007
ClinicalTrials.gov Identifier:	NCT00141934
Health Authority:	United States: Food and Drug Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Germany: Federal Institute for Drugs and Medical Devices; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Bulgaria: Bulgarian Drug Agency; Ukraine: Ministry of Health

Keywords provided by Sosei:

Rheumatoid Arthritis
RA
ACR20 endpoint
Tender/swollen joints

Improvement in pain
Health assessment questionnaire
Profile of mood states

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis
Connective Tissue Diseases

Arthritis, Rheumatoid
Methotrexate
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 13, 2009