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

NCT ID: NCT00141934

Last Updated: 2007-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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AD 452

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sosei

INDUSTRY

Sponsor Role lead

Locations

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Clinical Research of West Florida, Inc

Clearwater, Florida, United States

Site Status

Center for Rheumatology, Immunology and Arthritis

Fort Lauderdale, Florida, United States

Site Status

Ocala Rheumatology Research Center

Ocala, Florida, United States

Site Status

Sarasota Arthritis Research Center

Sarasota, Florida, United States

Site Status

Advent Clinical Research Centers, Inc.

St. Petersburg, Florida, United States

Site Status

Dept of Rheumatology, Columbia Medical Practice

Columbia, Maryland, United States

Site Status

Anderson and Collins Clinical Research, Inc.

Edison, New Jersey, United States

Site Status

Station Avenue

Haddon Heights, New Jersey, United States

Site Status

Atlantic Coast Research LLC

Toms River, New Jersey, United States

Site Status

Rheumatic Disease Associates

Willow Grove, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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P-AD452-022

Identifier Type: -

Identifier Source: org_study_id