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

This study has been completed.
Sponsor:
Information provided by:
Sosei
ClinicalTrials.gov Identifier:
NCT00141934
First received: August 31, 2005
Last updated: April 4, 2007
Last verified: April 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Florida
Clinical Research of West Florida, Inc
Clearwater, Florida, United States, 33765
Center for Rheumatology, Immunology and Arthritis
Fort Lauderdale, Florida, United States, 33334
Ocala Rheumatology Research Center
Ocala, Florida, United States, 34474
Sarasota Arthritis Research Center
Sarasota, Florida, United States, 34239
Advent Clinical Research Centers, Inc.
St. Petersburg, Florida, United States, 33703
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
Station Avenue
Haddon Heights, New Jersey, United States, 08035
Atlantic Coast Research LLC
Toms River, New Jersey, United States, 08755
United States, Pennsylvania
Rheumatic Disease Associates
Willow Grove, Pennsylvania, United States, 19090
Sponsors and Collaborators
Sosei
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141934     History of Changes
Other Study ID Numbers: P-AD452-022
Study First Received: August 31, 2005
Last Updated: April 4, 2007
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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014