A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.
This study has been completed.
Sponsor:
Sosei
Information provided by:
Sosei
ClinicalTrials.gov Identifier:
NCT00141934
First received: August 31, 2005
Last updated: April 4, 2007
Last verified: April 2007
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
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 | |
| 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 May 19, 2013