Clinical trial NCT00647270: Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
Official title: A Multi-center, Randomized, Double-blind,Placebo-controlled Study Comparing 80 mg of Adalimumab With Placebo, and Demonstrating the Non-inferiority of Monthly 80 mg Adalimumab Dosing Compared With 40 mg Adalimumab Every Other Week Dosing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo and demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab every other week.

Detailed description: The objective of this study is to demonstrate the efficacy of 80 mg adalimumab monthly dosing compared with placebo as measured by ACR20 response criteria following 12 weeks of therapy. The study is also designed to demonstrate the non-inferiority of monthly dosing of 80 mg adalimumab compared with dosing of 40 mg adalimumab eow as measured by ACR20 response criteria at Week 12.

Eligibility criteria: Inclusion Criteria:

* Subject \> 18 years of age
* Subject has a diagnosis of RA as defined by the 1987-revised ACR-classification criteria and has a disease duration for a minimum of three months
* Subject must meet the following two criteria: a) At least 6 swollen joints out of 66 assessed, or b) At least 6 tender joints out of 68 assessed
* If a subject is on MTX, the doses must be stable for at least 4 weeks prior to Screening blood draw and follow standard recommendations for MTX treatment
* Subject is judged to be in generally good health as determined by the principal investigator

Exclusion Criteria:

* Subject has previous exposure to any systemic anti-TNF therapy (eg, infliximab, etanercept, certolizumab pegol or golimumab) including adalimumab
* Subject has a history of acute inflammatory joint disease of different origin other than RA
* Subject has been treated with any investigational biologic agents
* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant

Primary outcomes:
measure: The Number of Responders According to the American College of Rheumatology (ACR) 20 Response Criteria at Week 12 Involving the Comparison of Adalimumab 80 mg Monthly Dose Versus Placebo and Adalimumab 40 mg Every Other Week (Eow)
timeFrame: Week 12
Secondary outcomes:
measure: Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
timeFrame: Baseline and Week 12
measure: Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
timeFrame: Baseline and Week 12
measure: Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
timeFrame: Baseline and Week 12
measure: Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Huntsville
country: United States
state: Alabama
city: Tuscaloosa
country: United States
state: Alabama
city: Paradise Valley
country: United States
state: Arizona
city: Hemet
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Santa Monica
country: United States
state: California
city: Torrance
country: United States
state: California
city: Victorville
country: United States
state: California
city: West Hills
country: United States
state: California
city: Wheatridge
country: United States
state: Colorado
city: Aventura
country: United States
state: Florida
city: Orange Park
country: United States
state: Florida
city: Palm Harbor
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Vero Beach
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Moline
country: United States
state: Illinois
city: Springfield
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Covington
country: United States
state: Louisiana
city: Brighton
country: United States
state: Michigan
city: Passaic
country: United States
state: New Jersey
city: Bronx
country: United States
state: New York
city: Smithtown
country: United States
state: New York
city: Ashville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: Monroe
country: United States
state: North Carolina
city: Oklahoma City
country: United States
state: Oklahoma
city: Bend
country: United States
state: Oregon
city: Bethlehem
country: United States
state: Pennsylvania
city: Duncansville
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: West Reading
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Greenville
country: United States
state: South Carolina
city: Jackson
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Ogden
country: United States
state: Utah
city: Olympia
country: United States
state: Washington
city: Glendale
country: United States
state: Wisconsin
city: Brisbane
country: Australia
state: Queensland
city: Cairns
country: Australia
state: Queensland
city: Winnipeg
country: Canada
state: Manitoba
city: Winnipeg
country: Canada
state: Manitoba
city: Fredericton
country: Canada
state: New Brunswick
city: St. John's
country: Canada
state: Newfoundland and Labrador
city: Lunenburg
country: Canada
state: Nova Scotia
city: Burlington
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: St. Catherines
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Sainte-Foy
country: Canada
state: Quebec
city: St. Eustache
country: Canada
state: Quebec
city: Quebec
country: Canada
city: Bad Nauheim
country: Germany
city: Berlin-Buch
country: Germany
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Freiburg
country: Germany
city: Muenchen
country: Germany
city: Wuerzburg
country: Germany
city: Zerbst
country: Germany
city: Caguas
country: Puerto Rico
city: Ponce
country: Puerto Rico
city: Wirral
country: United Kingdom
state: Cheshire
city: Liverpool
country: United Kingdom
state: Merseyside
city: Oxford
country: United Kingdom
state: Oxfordshire
city: Bath
country: United Kingdom
state: Somerset
city: Cannock
country: United Kingdom
state: Staffordshire
city: Newcastle upon Tyne
country: United Kingdom
state: Tyne and Wear
city: Leeds
country: United Kingdom
state: Yorkshire
city: Huddersfield
country: United Kingdom
state: York
Study officials:
affiliation: Abbott
name: Laura Redden, MD
role: STUDY_DIRECTOR
References:
citation: Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.