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

Rheumatoid Arthritis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141934
• Other study ID #: P-AD452-022
• Status: Completed
• Phase: Phase 2
• First received: August 31, 2005
• Last updated: April 4, 2007
• Start date: August 2005

Study information

• Verified date: April 2007
• Source: Sosei
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesSerbia and Montenegro: Agency for Drugs and Medicinal DevicesBulgaria: Bulgarian Drug AgencyUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• AD 452

Locations

Country	Name	City	State
United States	Clinical Research of West Florida, Inc	Clearwater	Florida
United States	Dept of Rheumatology, Columbia Medical Practice	Columbia	Maryland
United States	Anderson and Collins Clinical Research, Inc.	Edison	New Jersey
United States	Center for Rheumatology, Immunology and Arthritis	Fort Lauderdale	Florida
United States	Station Avenue	Haddon Heights	New Jersey
United States	Ocala Rheumatology Research Center	Ocala	Florida
United States	Sarasota Arthritis Research Center	Sarasota	Florida
United States	Advent Clinical Research Centers, Inc.	St. Petersburg	Florida
United States	Atlantic Coast Research LLC	Toms River	New Jersey
United States	Rheumatic Disease Associates	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sosei

Country where clinical trial is conducted

United States,