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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT00141934

Public ClinicalTrials.gov record NCT00141934. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 1:17 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00141934
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Sosei
Industry
Enrollment
232 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 31, 2005
Primary completion
Not listed
Completion
Not listed
Last update posted
Apr 4, 2007

Started 2005

United States locations

U.S. sites
10
U.S. states
4
U.S. cities
10
Facility City State ZIP Site status
Clinical Research of West Florida, Inc Clearwater Florida 33765
Center for Rheumatology, Immunology and Arthritis Fort Lauderdale Florida 33334
Ocala Rheumatology Research Center Ocala Florida 34474
Sarasota Arthritis Research Center Sarasota Florida 34239
Advent Clinical Research Centers, Inc. St. Petersburg Florida 33703
Dept of Rheumatology, Columbia Medical Practice Columbia Maryland 21045
Anderson and Collins Clinical Research, Inc. Edison New Jersey 08817
Station Avenue Haddon Heights New Jersey 08035
Atlantic Coast Research LLC Toms River New Jersey 08755
Rheumatic Disease Associates Willow Grove Pennsylvania 19090

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00141934, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 4, 2007 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00141934 live on ClinicalTrials.gov.

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