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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00647270




Registration number
NCT00647270
Ethics application status
Date submitted
27/03/2008
Date registered
31/03/2008
Date last updated
11/04/2011

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
M10-261
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - adalimumab
Treatment: Drugs - Placebo
Treatment: Drugs - adalimumab

Placebo Comparator: Placebo - Placebo 12 weeks, 40mg adalimumab remaining 12 weeks

Active Comparator: 40 mg - 40 mg every other week

Active Comparator: 80 mg - 80 mg monthly


Treatment: Drugs: adalimumab
Pre-filled syringe. See arm for more detail

Treatment: Drugs: Placebo
Pre-filled syringe. See arm for more detail

Treatment: Drugs: adalimumab
Pre-filled syringe. See arm for more detail

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and Week 12
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline and Week 12
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline and Week 12
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline and Week 12

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Brisbane
Recruitment hospital [2] 0 0
- Cairns
Recruitment postcode(s) [1] 0 0
4102 - Brisbane
Recruitment postcode(s) [2] 0 0
4870 - Cairns
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Oklahoma
Country [16] 0 0
United States of America
State/province [16] 0 0
Oregon
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
South Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Utah
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
Wisconsin
Country [24] 0 0
Canada
State/province [24] 0 0
Manitoba
Country [25] 0 0
Canada
State/province [25] 0 0
New Brunswick
Country [26] 0 0
Canada
State/province [26] 0 0
Newfoundland and Labrador
Country [27] 0 0
Canada
State/province [27] 0 0
Nova Scotia
Country [28] 0 0
Canada
State/province [28] 0 0
Ontario
Country [29] 0 0
Canada
State/province [29] 0 0
Quebec
Country [30] 0 0
Germany
State/province [30] 0 0
Bad Nauheim
Country [31] 0 0
Germany
State/province [31] 0 0
Berlin-Buch
Country [32] 0 0
Germany
State/province [32] 0 0
Berlin
Country [33] 0 0
Germany
State/province [33] 0 0
Frankfurt
Country [34] 0 0
Germany
State/province [34] 0 0
Freiburg
Country [35] 0 0
Germany
State/province [35] 0 0
Muenchen
Country [36] 0 0
Germany
State/province [36] 0 0
Wuerzburg
Country [37] 0 0
Germany
State/province [37] 0 0
Zerbst
Country [38] 0 0
Puerto Rico
State/province [38] 0 0
Caguas
Country [39] 0 0
Puerto Rico
State/province [39] 0 0
Ponce
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Cheshire
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Merseyside
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Oxfordshire
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Somerset
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Staffordshire
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Tyne and Wear
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Yorkshire
Country [47] 0 0
United Kingdom
State/province [47] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00647270
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Laura Redden, MD
Address 0 0
Abbott
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications