A Multicenter, Randomized, Double-Period, Double − Blind Study to Determine the Optimal Protocol for Treatment Initiation With Methotrexate and Adalimumab Combination Therapy in Patients With Early Rheumatoid Arthritis (OPTIMA)
This was a 78-week, multicenter, randomized, double-blind, double-treatment period study
designed to compare the safety and efficacy of adalimumab and MTX with placebo and MTX in
subjects with early RA. Subjects were randomized to receive adalimumab 40 mg every other
week (eow) or placebo subcutaneous injections in combination with orally administered MTX
for 26 weeks (Period 1). All subjects in all arms received open-label MTX weekly throughout
the study (both Period 1 and Period 2).
At Weeks 22 and 26, subjects were assessed for achievement of low disease activity, defined
as a DAS28 score below 3.2. DAS28 is a measure of RA disease activity calculated using the
number of tender and swollen joints (out of a total of 28), C-reactive protein level (CRP, a
blood marker of inflammation), and the patient's global assessment of disease activity
(indicated by marking a 10 cm line between very good and very bad). Subjects who achieved
low disease activity at Week 22 and 26 in the adalimumab arm at the end of Period 1 were
randomized to receive MTX monotherapy (placebo and MTX) or combination therapy (adalimumab
and MTX) in a 1:1 ratio for the duration of Period 2 (52 weeks, i.e., to Week 78 of the
study). Subjects achieving low disease activity at Week 22 and 26 in the placebo arm (MTX
monotherapy) at the end of Period 1 continued to receive MTX monotherapy (and placebo
injections in a blinded fashion) for the duration of Period 2. Subjects failing to achieve
low disease activity at Week 22 and 26 at the end of Period 1 received open-label
combination therapy during Period 2 regardless of treatment assignment in Period 1.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Number of Subjects With Low Disease Activity (DAS28 Less Than 3.2) and No Radiographic Progression From Baseline (Change in mTSS Less Than or Equal to 0.5) at Week 78, Arm 2 vs. Arm 4
The Disease Activity Score (DAS28) is calculated using the number of tender and swollen joints (out of 28 counted), C-reactive protein level, and the patient's global assessment of disease activity. The calculated range of DAS28 is 0.49 to 9.07, with scores below 3.2 indicating low disease activity. For the modified Total Sharp score (mTSS), x-rays of hand/wrist and feet joints are scored for erosions (0 to 5) and joint space narrowing (0 to 4). The erosion score and the narrowing score are added to determine the total score, which ranges from 0 (no damage) to 448.
Week 78
No
Laura Redden, MD, PhD
Study Director
Abbott
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
M06-810
NCT00420927
December 2006
July 2010
Name | Location |
---|---|
Site Reference ID/Investigator# 4560 | Birmingham, Alabama 35205 |
Site Reference ID/Investigator# 4547 | Birmingham, Alabama 35294-7201 |
Site Reference ID/Investigator# 6222 | Huntsville, Alabama 35801 |
Site Reference ID/Investigator# 4537 | Mobile, Alabama 36608 |
Site Reference ID/Investigator# 6758 | Tuscaloosa, Alabama 35406 |
Site Reference ID/Investigator# 9323 | Hemet, California 92543 |
Site Reference ID/Investigator# 4568 | La Jolla, California 92037-0943 |
Site Reference ID/Investigator# 4535 | Palm Desert, California 92260 |
Site Reference ID/Investigator# 4571 | Santa Monica, California 90404 |
Site Reference ID/Investigator# 9271 | Torrance, California 90505 |
Site Reference ID/Investigator# 10746 | Victorville, California 92395 |
Site Reference ID/Investigator# 4559 | Denver, Colorado 80230 |
Site Reference ID/Investigator# 6229 | Aventura, Florida 33180 |
Site Reference ID/Investigator# 10603 | Lake Mary, Florida 32746 |
Site Reference ID/Investigator# 9325 | Orange Park, Florida 32073 |
Site Reference ID/Investigator# 4550 | Palm Harbor, Florida 34684 |
Site Reference ID/Investigator# 4570 | Sarasota, Florida 34239 |
Site Reference ID/Investigator# 4601 | Tampa, Florida 33614 |
Site Reference ID/Investigator# 4552 | Vero Beach, Florida 32960 |
Site Reference ID/Investigator# 10745 | Meridian, Idaho 83642 |
Site Reference ID/Investigator# 4548 | Chicago, Illinois 60612 |
Site Reference ID/Investigator# 4557 | Springfield, Illinois 62704 |
Site Reference ID/Investigator# 4605 | Wichita, Kansas 67203 |
Site Reference ID/Investigator# 10741 | Wheaton, Maryland 20902 |
Site Reference ID/Investigator# 6417 | Fall River, Massachusetts 02720 |
Site Reference ID/Investigator# 4561 | Dover, New Hampshire 03820 |
Site Reference ID/Investigator# 11222 | Freehold, New Jersey 07728 |
Site Reference ID/Investigator# 6228 | Passaic, New Jersey 07055 |
Site Reference ID/Investigator# 4544 | Albuquerque, New Mexico 87102 |
Site Reference ID/Investigator# 12821 | Bronx, New York 10461 |
Site Reference ID/Investigator# 4534 | Orchard Park, New York 14127 |
Site Reference ID/Investigator# 9324 | Plainview, New York 11803 |
Site Reference ID/Investigator# 4600 | Smithtown, New York 11787 |
Site Reference ID/Investigator# 4549 | Mayfield Village, Ohio 44143 |
Site Reference ID/Investigator# 6227 | Bend, Oregon 97701 |
Site Reference ID/Investigator# 4546 | Duncansville, Pennsylvania 16635 |
Site Reference ID/Investigator# 4564 | West Reading, Pennsylvania 19611-1124 |
Site Reference ID/Investigator# 4558 | Wexford, Pennsylvania 15090 |
Site Reference ID/Investigator# 4533 | Charleston, South Carolina 29406 |
Site Reference ID/Investigator# 7482 | Greenville, South Carolina 29601 |
Site Reference ID/Investigator# 10743 | Jackson, Tennessee 38305 |
Site Reference ID/Investigator# 4562 | Nashville, Tennessee 37205 |
Site Reference ID/Investigator# 4536 | Dallas, Texas 75231 |
Site Reference ID/Investigator# 4538 | Houston, Texas 77074 |
Site Reference ID/Investigator# 6899 | San Antonio, Texas 78217 |
Site Reference ID/Investigator# 6381 | Tyler, Texas 75701 |
Site Reference ID/Investigator# 10744 | Seattle, Washington 98133 |
Site Reference ID/Investigator# 4545 | Glendale, Wisconsin 53217 |
Site Reference ID/Investigator# 4572 | Oak Creek, Wisconsin 53154 |