Back to resultsStudy 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
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
adalimumab
Placebo
adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Placebo
40 mg
80 mg
Arm Description
Placebo 12 weeks, 40mg adalimumab remaining 12 weeks
40 mg every other week
80 mg monthly
Outcomes
Primary Outcome Measures
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)
Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit
Secondary Outcome Measures
Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00647270
Brief Title
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
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 12 weeks, 40mg adalimumab remaining 12 weeks
Arm Title
40 mg
Arm Type
Active Comparator
Arm Description
40 mg every other week
Arm Title
80 mg
Arm Type
Active Comparator
Arm Description
80 mg monthly
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Pre-filled syringe. See arm for more detail
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pre-filled syringe. See arm for more detail
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
Pre-filled syringe. See arm for more detail
Primary Outcome Measure Information:
Title
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)
Description
Comparison of adalimumab 80 mg monthly dose versus placebo and adalimumab 40 mg eow in the number of responders with ACR criteria improvement consisting of 20%, (ACR20) reduction in tender or swollen joint counts (TJC or SJC, respectively) and 20% improvement in 3 of the following 5 criteria: [1] physician's global assessment of disease activity (PGA), [2] subject's assessment of disease activity, [3] subject's assessment of pain, [4] subject's assessment of physical disability via a health assessment questionnaire disability index(HAQ-DI), and [5] C-reactive protein (CRP) at each visit
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
Description
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Time Frame
Baseline and Week 12
Title
Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
Description
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Time Frame
Baseline and Week 12
Title
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)
Description
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Time Frame
Baseline and Week 12
Title
Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])
Description
The HAQ-DI is a self-reported subject measure of physical function calculated as the mean of 8 category scores: Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. Each category score is calculated as the maximum of the scores for the questions within the category. The HAQ-DI is expressed on a scale of 0 (without any difficulty) to 3 (unable to do) representing an average score across the category. Scores for at least 6 categories are needed to compute the HAQ score. Changes to lower scores indicate improvement in physical function.
Time Frame
Baseline and Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Redden, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
City
Tuscaloosa
State/Province
Alabama
ZIP/Postal Code
35406
Country
United States
City
Paradise Valley
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
City
Hemet
State/Province
California
ZIP/Postal Code
92543
Country
United States
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
City
Victorville
State/Province
California
ZIP/Postal Code
92395
Country
United States
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
City
Wheatridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
City
Moline
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40515
Country
United States
City
Covington
State/Province
Louisiana
ZIP/Postal Code
70433
Country
United States
City
Brighton
State/Province
Michigan
ZIP/Postal Code
48116
Country
United States
City
Passaic
State/Province
New Jersey
ZIP/Postal Code
07055
Country
United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
City
Smithtown
State/Province
New York
ZIP/Postal Code
11787
Country
United States
City
Ashville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
City
Monroe
State/Province
North Carolina
ZIP/Postal Code
28112
Country
United States
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19152
Country
United States
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States
City
Glendale
State/Province
Wisconsin
ZIP/Postal Code
53217
Country
United States
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
City
Cairns
State/Province
Queensland
ZIP/Postal Code
4870
Country
Australia
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M3
Country
Canada
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3N 0K6
Country
Canada
City
Fredericton
State/Province
New Brunswick
ZIP/Postal Code
E3B 6H5
Country
Canada
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3E1
Country
Canada
City
Lunenburg
State/Province
Nova Scotia
ZIP/Postal Code
B0J 2C0
Country
Canada
City
Burlington
State/Province
Ontario
ZIP/Postal Code
L7M 4Y1
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2M 5N6
Country
Canada
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 3R7
Country
Canada
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 1A2
Country
Canada
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 5W6
Country
Canada
City
St. Catherines
State/Province
Ontario
ZIP/Postal Code
L2N 4H4
Country
Canada
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8X 5A6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
City
Sainte-Foy
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
City
St. Eustache
State/Province
Quebec
ZIP/Postal Code
J7P 4J2
Country
Canada
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
City
Bad Nauheim
ZIP/Postal Code
D-61231
Country
Germany
City
Berlin-Buch
ZIP/Postal Code
D-13125
Country
Germany
City
Berlin
ZIP/Postal Code
D-14109
Country
Germany
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
City
Muenchen
ZIP/Postal Code
80639
Country
Germany
City
Wuerzburg
ZIP/Postal Code
D-97070
Country
Germany
City
Zerbst
ZIP/Postal Code
D-39261
Country
Germany
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
City
Wirral
State/Province
Cheshire
ZIP/Postal Code
CH49 5PE
Country
United Kingdom
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L9 7AL
Country
United Kingdom
City
Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
City
Bath
State/Province
Somerset
ZIP/Postal Code
BA1 1RL
Country
United Kingdom
City
Cannock
State/Province
Staffordshire
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE7 7 DN
Country
United Kingdom
City
Leeds
State/Province
Yorkshire
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
City
Huddersfield
State/Province
York
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27338778
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.
Results Reference
derived
Learn more about this trial
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
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