A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Moderately to Severely Active Ulcerative Colitis
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed
to evaluate the efficacy and safety of adalimumab (ADA) in patients with moderately to
severely active ulcerative colitis (UC).
The duration of the study was up to 65 weeks, including a Screening Period of up to 3 weeks,
a double-blind (DB) placebo-controlled treatment period of up to 52 weeks, and a 70 day
follow-up phone call for participants who prematurely discontinued or who did not enroll in
the extension study NCT# 00573794 (M10-223).
Adult participants with moderate to severe UC (Mayo score of 6 to 12 points with endoscopy
subscore of 2 to 3 points), confirmed by colonoscopy with biopsy or flexible sigmoidoscopy
with biopsy, were to be enrolled at approximately 120 sites worldwide. Planned enrollment
was 500 participants.
Participants were to be stratified by prior exposure to infliximab and/or other anti-TNF
agents, and randomized in a 1:1 ratio to receive ADA or placebo by subcutaneous injection.
Participants assigned to the ADA treatment arm were to receive an induction dose of 160 mg
at Week 0 and 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4.
Participants assigned to the placebo treatment arm were to receive matching placebo during
the same period of time. At or after Week 10, participants who met the criteria for
inadequate response could be switched to open-label (OL) ADA 40 mg eow beginning at Week 12.
Inadequate response was defined as:
- Partial Mayo score greater than or equal to Baseline score on 2 consecutive visits at
least 14 days apart (for participants with a partial Mayo score of 4 to 7 at Baseline).
- Partial Mayo score greater than or equal to 7 on 2 consecutive visits at least 14 days
apart (for participants with a partial Mayo score of 8 or 9 at Baseline).
Participants who demonstrated inadequate response at 2 consecutive visits at least 14 days
apart while on OL administration ADA 40 mg eow were permitted to dose escalate to ADA 40 mg
weekly (ew). Participants with persistent inadequate response while on ADA 40 mg ew may
have been discontinued from the study at the Investigator's discretion. Upon completion of
the study, participants had the option to enroll into the OL extension Study M10-223 in
which they could receive ADA treatment.
Efficacy and safety measurements were performed throughout the study. A follow-up phone
call was made 70 days after the last dose of study drug to obtain information on any ongoing
or new adverse events (AEs) for all participants who terminated early or who did not enroll
in the OL extension study.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 8
Clinical remission per Mayo score is defined as a total Mayo score of at least 2 and no individual subscore greater than 1. The Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 12 (severe disease) and is a composite of 4 subscores: Stool Frequency Subscore (SFS), Rectal Bleeding Subscore (RBS), Endoscopy Subscore, and Physician's Global Assessment Subscore (PGA), each of which ranges from 0 (normal) to 3 (severe disease).
Week 8
No
Roopal B Thakkar, M.D.
Study Director
Abbott
Canada: Health Canada
M06-827
NCT00408629
November 2006
March 2010
Name | Location |
---|---|
Site Ref # / Investigator 5394 | Anaheim, California 92801 |
Site Ref # / Investigator 3753 | Wheat Ridge, Colorado 80033 |
Site Ref # / Investigator 3754 | Hamden, Connecticut 06518 |
Site Ref # / Investigator 12903 | Gainesville, Florida 32607 |
Site Ref # / Investigator 3747 | Hollywood, Florida 33021 |
Site Ref # / Investigator 5106 | Jacksonville, Florida 32256 |
Site Ref # / Investigator 11601 | Naples, Florida 34102 |
Site Ref # / Investigator 6846 | Sarasota, Florida 34239 |
Site Ref # / Investigator 3742 | Winter Park, Florida 32789 |
Site Ref # / Investigator 3760 | Zephyrhills, Florida 33542 |
Site Ref # / Investigator 3739 | Atlanta, Georgia 30342 |
Site Ref # / Investigator 7658 | Macon, Georgia 31201 |
Site Ref # / Investigator 5397 | Moline, Illinois 61265 |
Site Ref # / Investigator 7453 | Topeka, Kansas 66606 |
Site Ref # / Investigator 3759 | Annapolis, Maryland 21401 |
Site Ref # / Investigator 3762 | Annapolis, Maryland 21401 |
Site Ref # / Investigator 3738 | Lutherville, Maryland 21093 |
Site Ref # / Investigator 7472 | Troy, Michigan 48098 |
Site Ref # / Investigator 3744 | Rochester, Minnesota 55905 |
Site Ref # / Investigator 6088 | St. Louis, Missouri 63128 |
Site Ref # / Investigator 3756 | Great Neck, New York 11021 |
Site Ref # / Investigator 3752 | Charlotte, North Carolina 28207 |
Site Ref # / Investigator 3758 | Jacksonville, North Carolina 28546 |
Site Ref # / Investigator 3745 | Cincinnati, Ohio 45219 |
Site Ref # / Investigator 7709 | Oklahoma City, Oklahoma 73104 |
Site Ref # / Investigator 3740 | Tulsa, Oklahoma 74104 |
Site Ref # / Investigator 3765 | Sayre, Pennsylvania 18840 |
Site Ref # / Investigator 3741 | Columbia, South Carolina 29204 |
Site Ref # / Investigator 3737 | Germantown, Tennessee 38138 |
Site Ref # / Investigator 3743 | Nashville, Tennessee 37212-1610 |
Site Ref # / Investigator 6077 | Nashville, Tennessee 37203 |
Site Ref # / Investigator 5107 | Nashville, Tennessee 37205 |
Site Ref # / Investigator 5398 | Ogden, Utah 84405 |
Site Ref # / Investigator 3750 | Spokane, Washington 99204 |
Site Ref # / Investigator 8064 | Spokane, Washington 99202 |
Site Ref # / Investigator 3761 | West Bend, Wisconsin 53095 |