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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

Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: adalimumab (Drug); Placebo (Drug); adalimumab (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Abbott

Official(s) and/or principal investigator(s):
Laura Redden, MD, Study Director, Affiliation: Abbott

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.

Clinical Details

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

Primary outcome: 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)

Secondary outcome:

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

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

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

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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Quebec G1V 3M7, Canada

Bad Nauheim D-61231, Germany

Berlin-Buch D-13125, Germany

Berlin D-14109, Germany

Frankfurt 60596, Germany

Freiburg D-79106, Germany

Muenchen 80639, Germany

Wuerzburg D-97070, Germany

Zerbst D-39261, Germany

Caguas 00725, Puerto Rico

Ponce 00716, Puerto Rico

Huntsville, Alabama 35801, United States

Tuscaloosa, Alabama 35406, United States

Paradise Valley, Arizona 85253, United States

Hemet, California 92543, United States

Long Beach, California 90806, United States

Santa Monica, California 90404, United States

Torrance, California 90505, United States

Victorville, California 92395, United States

West Hills, California 91307, United States

Wirral, Cheshire CH49 5PE, United Kingdom

Wheatridge, Colorado 80033, United States

Aventura, Florida 33180, United States

Orange Park, Florida 32073, United States

Palm Harbor, Florida 34684, United States

Sarasota, Florida 34239, United States

Tampa, Florida 33614, United States

Vero Beach, Florida 32960, United States

Atlanta, Georgia 30342, United States

Chicago, Illinois 60612, United States

Moline, Illinois 61201, United States

Springfield, Illinois 62704, United States

Wichita, Kansas 67203, United States

Lexington, Kentucky 40515, United States

Covington, Louisiana 70433, United States

Winnipeg, Manitoba R3A 1M3, Canada

Winnipeg, Manitoba R3N 0K6, Canada

Liverpool, Merseyside L9 7AL, United Kingdom

Brighton, Michigan 48116, United States

Fredericton, New Brunswick E3B 6H5, Canada

Passaic, New Jersey 07055, United States

Bronx, New York 10461, United States

Smithtown, New York 11787, United States

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

Ashville, North Carolina 28801, United States

Charlotte, North Carolina 28209, United States

Hickory, North Carolina 28601, United States

Monroe, North Carolina 28112, United States

Lunenburg, Nova Scotia B0J 2C0, Canada

Oklahoma City, Oklahoma 73112, United States

Burlington, Ontario L7M 4Y1, Canada

Hamilton, Ontario L8N 1Y2, Canada

Hamilton, Ontario L8N 2B6, Canada

Kitchener, Ontario N2M 5N6, Canada

Newmarket, Ontario L3Y 3R7, Canada

Ottawa, Ontario K1H 1A2, Canada

Sarnia, Ontario N7T 5W6, Canada

St. Catherines, Ontario L2N 4H4, Canada

Windsor, Ontario N8X 5A6, Canada

Bend, Oregon 97701, United States

Oxford, Oxfordshire OX3 7LD, United Kingdom

Bethlehem, Pennsylvania 18015, United States

Duncansville, Pennsylvania 16635, United States

Philadelphia, Pennsylvania 19152, United States

West Reading, Pennsylvania 19611, United States

Montreal, Quebec H2L 1S6, Canada

Sainte-Foy, Quebec G1W 4R4, Canada

St. Eustache, Quebec J7P 4J2, Canada

Brisbane, Queensland 4102, Australia

Cairns, Queensland 4870, Australia

Bath, Somerset BA1 1RL, United Kingdom

Charleston, South Carolina 29406, United States

Greenville, South Carolina 29601, United States

Cannock, Staffordshire WS11 5XY, United Kingdom

Jackson, Tennessee 38305, United States

Nashville, Tennessee 37205, United States

Dallas, Texas 75235, United States

Houston, Texas 77034, United States

Houston, Texas 77074, United States

San Antonio, Texas 78217, United States

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

Ogden, Utah 84405, United States

Olympia, Washington 98502, United States

Glendale, Wisconsin 53217, United States

Huddersfield, York HD3 3EA, United Kingdom

Leeds, Yorkshire LS7 4SA, United Kingdom

Additional Information

Starting date: December 2007
Last updated: April 7, 2011

Page last updated: August 23, 2015

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