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Clinical Trial: A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.
This study is currently recruiting patients.
Verified by Arakis August 2005
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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
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:
Expected Total Enrollment: 232
Study start: August 2005
Eligibility
Ages Eligible for Study: 18 Years - 75 Years, Genders Eligible for Study: Both
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.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00141934
Pennsylvania
Rheumatic Disease Associates, Willow Grove, Pennsylvania, 19090, United States; Recruiting
Lilian Walsh, RN 215-657-9977 rdacru@arthritispa.com
Elana Eisner, MD, Principal Investigator
Elana Eisner, MD, Principal Investigator
More Information
Study ID Numbers: P-AD452-022
Last Updated: September 1, 2005
Record first received: August 31, 2005
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 Medicinal Devices; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Bulgaria: Bulgarian Drug Agency; Ukraine: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06
Last Updated: September 1, 2005
Record first received: August 31, 2005
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 Medicinal Devices; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Bulgaria: Bulgarian Drug Agency; Ukraine: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06
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