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

NCT00647270 | Completed Phase 3 Results

• 1 other identifier: M10-261
• Study Type: interventional
• Target: 420
• Locations: 6 countries
• Sites: 86

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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

  Week 12

Secondary Outcomes (4)

• Within Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)

  Baseline and Week 12

• Within Group Mean Change From Baseline in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])

  Baseline and Week 12

• Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Observed)

  Baseline and Week 12

• Between Group Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 (Last Observation Carried Forward [LOCF])

  Baseline and Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo 12 weeks, 40mg adalimumab remaining 12 weeks

Drug: Placebo

40 mg

ACTIVE COMPARATOR

40 mg every other week

Drug: adalimumab

80 mg

ACTIVE COMPARATOR

80 mg monthly

Drug: adalimumab

Interventions

adalimumab DRUG

Pre-filled syringe. See arm for more detail

Also known as: ABT-D2E7, Humira

40 mg

Placebo DRUG

Pre-filled syringe. See arm for more detail

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott: lead

Study Sites (86)

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Huntsville, Alabama, 35801, United States

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Tuscaloosa, Alabama, 35406, United States

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Paradise Valley, Arizona, 85253, United States

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Hemet, California, 92543, United States

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Long Beach, California, 90806, United States

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Santa Monica, California, 90404, United States

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Torrance, California, 90505, United States

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Victorville, California, 92395, United States

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West Hills, California, 91307, United States

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Wheat Ridge, Colorado, 80033, United States

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Aventura, Florida, 33180, United States

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Orange Park, Florida, 32073, United States

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Palm Harbor, Florida, 34684, United States

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Sarasota, Florida, 34239, United States

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Tampa, Florida, 33614, United States

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Vero Beach, Florida, 32960, United States

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Atlanta, Georgia, 30342, United States

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Chicago, Illinois, 60612, United States

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Moline, Illinois, 61201, United States

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Springfield, Illinois, 62704, United States

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Wichita, Kansas, 67203, United States

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Lexington, Kentucky, 40515, United States

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Covington, Louisiana, 70433, United States

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Brighton, Michigan, 48116, United States

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Passaic, New Jersey, 07055, United States

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Smithtown, New York, 11787, United States

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The Bronx, New York, 10461, United States

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Ashville, North Carolina, 28801, United States

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Charlotte, North Carolina, 28209, United States

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Hickory, North Carolina, 28601, United States

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Monroe, North Carolina, 28112, United States

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Oklahoma City, Oklahoma, 73112, United States

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Bend, Oregon, 97701, United States

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Bethlehem, Pennsylvania, 18015, United States

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Duncansville, Pennsylvania, 16635, United States

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Philadelphia, Pennsylvania, 19152, United States

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West Reading, Pennsylvania, 19611, United States

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Charleston, South Carolina, 29406, United States

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Greenville, South Carolina, 29601, United States

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Jackson, Tennessee, 38305, United States

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Nashville, Tennessee, 37205, United States

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Dallas, Texas, 75235, United States

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Houston, Texas, 77034, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78217, United States

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Ogden, Utah, 84405, United States

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Olympia, Washington, 98502, United States

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Glendale, Wisconsin, 53217, United States

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Brisbane, Queensland, 4102, Australia

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Cairns, Queensland, 4870, Australia

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Winnipeg, Manitoba, R3A 1M3, Canada

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Winnipeg, Manitoba, R3N 0K6, Canada

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Fredericton, New Brunswick, E3B 6H5, Canada

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St. John's, Newfoundland and Labrador, A1B 3E1, Canada

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Lunenburg, Nova Scotia, B0J 2C0, Canada

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Burlington, Ontario, L7M 4Y1, Canada

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Hamilton, Ontario, L8N 1Y2, Canada

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Hamilton, Ontario, L8N 2B6, Canada

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Kitchener, Ontario, N2M 5N6, Canada

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Newmarket, Ontario, L3Y 3R7, Canada

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Ottawa, Ontario, K1H 1A2, Canada

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Saint Catherines, Ontario, L2N 4H4, Canada

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Sarnia, Ontario, N7T 5W6, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Montreal, Quebec, H2L 1S6, Canada

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Québec, Quebec, G1V 3M7, Canada

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Saint-Eustache, Quebec, J7P 4J2, Canada

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Sainte-Foy, Quebec, G1W 4R4, Canada

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Bad Nauheim, D-61231, Germany

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Berlin, D-14109, Germany

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Buch, D-13125, Germany

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Frankfurt, 60596, Germany

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Freiburg im Breisgau, D-79106, Germany

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München, 80639, Germany

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Würzburg, D-97070, Germany

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Zerbst, D-39261, Germany

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Caguas, 00725, Puerto Rico

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Ponce, 00716, Puerto Rico

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Metropolitan Borough of Wirral, Cheshire, CH49 5PE, United Kingdom

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Liverpool, Merseyside, L9 7AL, United Kingdom

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Oxford, Oxfordshire, OX3 7LD, United Kingdom

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Bath, Somerset, BA1 1RL, United Kingdom

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Cannock, Staffordshire, WS11 5XY, United Kingdom

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Newcastle upon Tyne, Tyne and Wear, NE7 7 DN, United Kingdom

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Leeds, Yorkshire, LS7 4SA, United Kingdom

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Huddersfield, York, HD3 3EA, United Kingdom

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Related Publications (1)

• 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.

  PMID: 27338778 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Abbott identified Investigator non-compliance with the protocol requirements at one site and made the decision to exclude the data from this site from all efficacy analyses. Sample size was too small to demonstrate superiority and non-inferiority.

Results Point of Contact

• Title: Global Medical Services
• Organization: Abbott

800-633-9110

Study Officials

• Laura Redden, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: March 31, 2008
• Study Start: December 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 11, 2011
• Results First Posted: May 10, 2010

Record last verified: 2011-04

Locations

CA (18); AU (2); US (48); DE (8); GB (8); PR (2)