Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

Active Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00959036
• Other study ID #: 3242K1-2000
• Secondary ID: B2271003
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 13, 2009
• Last updated: January 28, 2013
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: January 2013
• Source: Ablynx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Active Rheumatoid Arthritis
• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• ATN-103
10 mg every 4 weeks until week 12
• ATN-103
10 mg every 8 weeks until week 12
• ATN-103
30 mg every 4 weeks until week 12
• ATN-103
80 mg every 4 weeks until week 12
• ATN-103
80 mg every 8 weeks until week 12
• Placebo
Placebo every 4 weeks
• Methotrexate

Locations

Country	Name	City	State
Belgium	Investigational Site	Bruxelles
Belgium	Investigational Site	Leuven
Canada	Investigational Site	Kitchener	Ontario
Canada	Investigational Site	Ottawa	Ontario
Canada	Investigational Site	Quebec
Canada	Investigational Site	St. Catharines	Ontario
Canada	Investigational Site	Toronto	Ontario
Canada	Investigational Site	Winnipeg	Manitoba
Germany	Investigational Site	Vogelsang	Gommern
Hungary	Investigational Site	Budapest
Hungary	Investigational Site	Debrecen
Russian Federation	Investigational Site	Kemerovo
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Moscow
Russian Federation	Investigational Site	Novosibirsk
Russian Federation	Investigational Site	Novosibirsk
Russian Federation	Investigational Site	Orenburg
Russian Federation	Investigational Site	Petrozavodsk
Russian Federation	Investigational Site	Ryazan
Russian Federation	Investigational Site	Vladimir
Russian Federation	Investigational Site	Yaroslavl
Russian Federation	Investigational Site	Yaroslavl
Serbia	Investigational Site	Belgrade
Serbia	Investigational Site	Niska Banja
South Africa	Investigational Site	Berea	KwaZulu-Natal
South Africa	Investigational Site	Cape Town
South Africa	Investigational Site	Cape Town
South Africa	Investigational Site	Pretoria
Switzerland	Investigational Site	Chur
Switzerland	Investigational Site	Zurich	ZH
United States	Investigational Site	Albuquerque	New Mexico
United States	Investigational Site	Allentown	Pennsylvania
United States	Investigational Site	Birmingham	Alabama
United States	Investigational Site	Bridgeport	Connecticut
United States	Investigational Site	Charlotte	North Carolina
United States	Investigational Site	Coeur d'Alene	Idaho
United States	Investigational Site	Columbia	South Carolina
United States	Investigational Site	Columbus	Ohio
United States	Investigational Site	Dallas	Texas
United States	Investigational Site	Frederick	Maryland
United States	Investigational Site	Freehold	New Jersey
United States	Investigational Site	Hickory	North Carolina
United States	Investigational Site	Houston	Texas
United States	Investigational Site	Huntsville	Alabama
United States	Investigational Site	Lake Mary	Florida
United States	Investigational Site	Lake Oswego	Oregon
United States	Investigational Site	Lansing	Michigan
United States	Investigational Site	Mineola	New York
United States	Investigational Site	Myrtle Beach	South Carolina
United States	Investigational Site	Nashville	Tennessee
United States	Investigational Site	Newark	Delaware
United States	Investigational Site	Ocala	Florida
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Oklahoma City	Oklahoma
United States	Investigational Site	Orlando	Florida
United States	Investigational Site	Peoria	Arizona
United States	Investigational Site	Port Orange	Florida
United States	Investigational Site	Riverside	California
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site	Scottsdale	Arizona
United States	Investigational Site	Tacoma	Washington
United States	Investigational Site	Tulsa	Oklahoma
United States	Investigational Site	Upland	California
United States	Investigational Site	Vero Beach	Florida
United States	Investigational Site	West Yarmouth	Massachusetts
United States	Investigational Site	Winston Salem	North Carolina
United States	Investigational Site	Winston-Salem	North Carolina
United States	Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Ablynx

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Hungary,  Russian Federation,  Serbia,  South Africa,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology (ACR) 20 response at week 16		6 months	No
Secondary	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		6 months	No