Clinical trial NCT00141934: A Multicentre Trial to Determine the Efficacy of AD 452 in RA Subjects.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
RA
ACR20 endpoint
Tender/swollen joints
Improvement in pain
Health assessment questionnaire
Profile of mood states
Lead sponsor: Sosei
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Clearwater
country: United States
facility: Clinical Research of West Florida, Inc
state: Florida
city: Fort Lauderdale
country: United States
facility: Center for Rheumatology, Immunology and Arthritis
state: Florida
city: Ocala
country: United States
facility: Ocala Rheumatology Research Center
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Research Center
state: Florida
city: St. Petersburg
country: United States
facility: Advent Clinical Research Centers, Inc.
state: Florida
city: Columbia
country: United States
facility: Dept of Rheumatology, Columbia Medical Practice
state: Maryland
city: Edison
country: United States
facility: Anderson and Collins Clinical Research, Inc.
state: New Jersey
city: Haddon Heights
country: United States
facility: Station Avenue
state: New Jersey
city: Toms River
country: United States
facility: Atlantic Coast Research LLC
state: New Jersey
city: Willow Grove
country: United States
facility: Rheumatic Disease Associates
state: Pennsylvania
Study officials:
References: