Clinical trial NCT00959036: Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis
Official title: A Seamless, Phase 1/2, Multiple Ascending Dose, Proof Of Concept Study Of ATN-103 Administered To Subjects With Active Rheumatoid Arthritis On A Background Of Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Active Rheumatoid Arthritis
Lead sponsor: Ablynx, a Sanofi company
Sponsor class: INDUSTRY
First posted: 2009-08-14
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of active rheumatoid arthritis on a stable background of methotrexate (7.5-25 mg weekly).

Exclusion Criteria:

* Any significant health problem other than rheumatoid arthritis
* Any clinically significant laboratory abnormalities
* Any prior use of B cell-depleting therapy

Primary outcomes:
measure: American College of Rheumatology (ACR) 20 response at week 16
timeFrame: 6 months
Secondary outcomes:
measure: Additional efficacy endpoints as measured by the number of swollen and tender joints, physician and patient global assessments of disease activity, ACR responses, DAS28, EULAR, and Health Outcome Assessments
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site
state: Alabama
city: Huntsville
country: United States
facility: Investigational Site
state: Alabama
city: Peoria
country: United States
facility: Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Investigational Site
state: Arizona
city: Riverside
country: United States
facility: Investigational Site
state: California
city: Upland
country: United States
facility: Investigational Site
state: California
city: Bridgeport
country: United States
facility: Investigational Site
state: Connecticut
city: Newark
country: United States
facility: Investigational Site
state: Delaware
city: Lake Mary
country: United States
facility: Investigational Site
state: Florida
city: Ocala
country: United States
facility: Investigational Site
state: Florida
city: Orlando
country: United States
facility: Investigational Site
state: Florida
city: Port Orange
country: United States
facility: Investigational Site
state: Florida
city: Vero Beach
country: United States
facility: Investigational Site
state: Florida
city: Coeur d'Alene
country: United States
facility: Investigational Site
state: Idaho
city: Frederick
country: United States
facility: Investigational Site
state: Maryland
city: West Yarmouth
country: United States
facility: Investigational Site
state: Massachusetts
city: Lansing
country: United States
facility: Investigational Site
state: Michigan
city: Freehold
country: United States
facility: Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Investigational Site
state: New Mexico
city: Mineola
country: United States
facility: Investigational Site
state: New York
city: Charlotte
country: United States
facility: Investigational Site
state: North Carolina
city: Hickory
country: United States
facility: Investigational Site
state: North Carolina
city: Winston Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Investigational Site
state: North Carolina
city: Columbus
country: United States
facility: Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site
state: Oklahoma
city: Lake Oswego
country: United States
facility: Investigational Site
state: Oregon
city: Allentown
country: United States
facility: Investigational Site
state: Pennsylvania
city: Columbia
country: United States
facility: Investigational Site
state: South Carolina
city: Myrtle Beach
country: United States
facility: Investigational Site
state: South Carolina
city: Nashville
country: United States
facility: Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: Tacoma
country: United States
facility: Investigational Site
state: Washington
city: Bruxelles
country: Belgium
facility: Investigational Site
city: Leuven
country: Belgium
facility: Investigational Site
city: Winnipeg
country: Canada
facility: Investigational Site
state: Manitoba
city: Kitchener
country: Canada
facility: Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Investigational Site
state: Ontario
city: St. Catharines
country: Canada
facility: Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Investigational Site
state: Ontario
city: Quebec
country: Canada
facility: Investigational Site
city: Vogelsang
country: Germany
facility: Investigational Site
state: Gommern
city: Budapest
country: Hungary
facility: Investigational Site
city: Debrecen
country: Hungary
facility: Investigational Site
city: Kemerovo
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Moscow
country: Russian Federation
facility: Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Investigational Site
city: Orenburg
country: Russian Federation
facility: Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: Investigational Site
city: Ryazan
country: Russian Federation
facility: Investigational Site
city: Vladimir
country: Russian Federation
facility: Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Investigational Site
city: Belgrade
country: Serbia
facility: Investigational Site
city: Niska Banja
country: Serbia
facility: Investigational Site
city: Berea
country: South Africa
facility: Investigational Site
state: KwaZulu-Natal
city: Cape Town
country: South Africa
facility: Investigational Site
city: Cape Town
country: South Africa
facility: Investigational Site
city: Pretoria
country: South Africa
facility: Investigational Site
city: Zurich
country: Switzerland
facility: Investigational Site
state: ZH
city: Chur
country: Switzerland
facility: Investigational Site
Study officials:
affiliation: Ablynx, a Sanofi company
name: Josefin-Beate Holz, MD
role: STUDY_DIRECTOR
References: