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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002781-20 | EudraCT Number |
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The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
This was a Phase 3, multicenter, randomized, double-blind (DB), placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-TNF monoclonal antibody adalimumab for the induction of clinical remission in participants with moderately to severely active ulcerative colitis (UC).
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 by flexible sigmoidoscopy with biopsy, were enrolled at 80 sites worldwide. The study enrolled 576 participants, including 186 participants under the original protocol and protocol Amendments 1 and 2, and 390 participants under protocol Amendments 3 and 4.
Participants enrolled in the study prior to Amendment 3 were randomized in a 1:1 ratio to receive adalimumab or placebo during the 12-week DB induction period. Participants received 4 injections of adalimumab 40 mg (160 mg) or 4 injections of placebo at Baseline (Week 0), followed by 2 injections of adalimumab 40 mg (80 mg) or 2 injections of placebo at Week 2, followed by 1 injection of adalimumab 40 mg or placebo at Weeks 4 and 6. At Week 8, participants randomized to placebo received 4 injections of adalimumab 40 mg (160 mg) followed by 2 injections of adalimumab 40 mg (80 mg) at Week 10. Participants randomized to adalimumab received 3 injections of placebo and 1 injection of adalimumab 40 mg at Week 8 and 1 injection of placebo and 1 injection of adalimumab 40 mg at Week 10. All participants continued to receive 1 injection of open-label (OL) adalimumab 40 mg every other week beginning at Week 12 up to Week 52 (or the early termination visit). Starting at Week 14, participants who had inadequate responses to treatment (as defined using partial Mayo scores) were permitted to dose escalate to adalimumab 40 mg weekly. Participants with persistent inadequate response while on weekly treatment could be discontinued from the study at the discretion of the investigator.
In August 2007, the study design was amended to incorporate an additional adalimumab induction dosing arm of 80/40 mg. Earlier that year, both 160/80-mg and 80/40-mg induction regimens had been approved in the EU as induction treatment for Crohn's disease. The adalimumab induction dosing regimen of 80/40 mg was therefore included so that both of these approved induction regimens would be evaluated for the induction of remission of UC.
Participants enrolled in the study after Amendment 3 were randomized in a 1:1:1 ratio to receive adalimumab (1 of 2 regimens) or placebo during the 8-week DB induction period. Participants received DB therapy from Baseline until Week 8 and OL therapy from Week 8 until the end of the study. In the first adalimumab dosing arm (adalimumab 80/40), participants received 2 injections of adalimumab 40 mg (80 mg) and 2 injections of placebo at Baseline followed by 1 injection of adalimumab 40 mg and 1 injection of placebo at Week 2, and 1 injection of adalimumab 40 mg every other week thereafter. In the second adalimumab DB induction dosing arm (adalimumab 160/80), participants received 4 injections of adalimumab 40 mg (160 mg) at Baseline followed by 2 injections of adalimumab 40 mg (80 mg) at Week 2, and 1 injection of adalimumab 40 mg every other week thereafter. Participants randomized to placebo received 4 injections of placebo at Baseline followed by 2 injections of placebo at Week 2, and 1 injection of placebo at Weeks 4 and 6. Beginning at Week 8, but after the Week 8 study assessments had been completed, all participants received 1 injection of OL adalimumab 40 mg every other week until Week 52 or early termination. Starting at Week 12, participants who had inadequate responses to treatment (as defined using partial Mayo scores) were permitted to dose escalate to adalimumab 40 mg weekly. Participants with persistent inadequate response while on weekly treatment could be discontinued from the study at the discretion of the investigator.
For the analysis of efficacy parameters during the DB Period through Week 8, only participants randomized under Protocol Amendment 3 or later were considered ("Efficacy Analysis Set - Induction" in the participant flow). For the analysis of efficacy parameters during the OL Period through Week 52, all randomized participants (under any version of the protocol) who received at least 1 dose of study drug were considered ("Efficacy Analysis Set - Maintenance" in the participant flow). For the analysis of safety parameters, all participants who received at least 1 dose of study drug were considered ("Safety Analysis Set" in the participant flow).
Twelve ranked secondary variables during the DB Period through Week 8 were to be tested in a hierarchical order to account for multiple testing. These variables are identified as "Ranked Secondary Endpoints" in the results section below. Additionally, non-ranked secondary variables during the OL Period through Week 52 were tested and are presented after the ranked secondary endpoints in the results section below.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab 80/40 | Experimental |
| |
| Adalimumab 160/80/40 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | Prefilled syringe, 40 mg (loading dose then every other week dosing). 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 | Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Ranked Secondary Endpoint #1: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). |
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The following eligibility criteria applied to participants enrolled following Amendment 3 to the study protocol.
Inclusion Criteria:
Male and female participants >= 18 years of age
Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline
Diagnosis of active ulcerative colitis confirmed by colonoscopy with biopsy or flexible sigmoidoscopy with biopsy during the Screening Period, with exclusion of infection
Active UC with a Mayo score of 6 to 12 points and endoscopy subscore of 2 to 3 points, despite concurrent treatment with at least 1 of the following (oral corticosteroids or immunosuppressants or both as defined below):
and/or
Concurrent therapy was not required for participants who were previously treated with corticosteroids or immunosuppressants (azathioprine or 6-MP) during the previous 5 years and, in the judgment of the investigator, have failed to respond to or could not tolerate their treatment.
Had to be able to self-administer or has caregiver who can reliably administer subcutaneous injections.
Had to be able and willing to give written informed consent and to comply with the requirements of this study protocol.
Female had to be either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or of childbearing potential and practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control included the following:
The results of the serum pregnancy test performed at the Screening Visit and urine pregnancy test performed at the Baseline Visit had to be negative.
Judged to be in generally good health as determined by the principal investigator
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roopal Thakkar, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 2080 | Birmingham | Alabama | 35209 | United States | ||
| Site Ref # / Investigator 6034 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29380251 | Derived | Ryan C, Sobell JM, Leonardi CL, Lynde CW, Karunaratne M, Valdecantos WC, Hendrickson BA. Safety of Adalimumab Dosed Every Week and Every Other Week: Focus on Patients with Hidradenitis Suppurativa or Psoriasis. Am J Clin Dermatol. 2018 Jun;19(3):437-447. doi: 10.1007/s40257-017-0341-6. | |
| 24067881 | Derived | Feagan BG, Sandborn WJ, Lazar A, Thakkar RB, Huang B, Reilly N, Chen N, Yang M, Skup M, Mulani P, Chao J. Adalimumab therapy is associated with reduced risk of hospitalization in patients with ulcerative colitis. Gastroenterology. 2014 Jan;146(1):110-118.e3. doi: 10.1053/j.gastro.2013.09.032. Epub 2013 Sep 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3). |
| FG001 | Adalimumab 80/40 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Efficacy Analysis Set - Induction |
|
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|
| adalimumab | Biological | Prefilled syringe, 40 mg (loading dose then every other week dosing). 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. |
|
|
| placebo | Biological | Placebo for 40 mg syringe. Matching placebo for loading dose and every other week dosing. Subjects received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab eow thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3). |
|
| Week 8 |
| Ranked Secondary Endpoint #2: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration) | Week 8 |
| Ranked Secondary Endpoint #3: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed | Week 8 |
| Ranked Secondary Endpoint #4: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo). | The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3) | Week 8 |
| Ranked Secondary Endpoint #5: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal | Week 8 |
| Ranked Secondary Endpoint #6: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 80/40 Versus Placebo). | Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | Week 8 |
| Ranked Secondary Endpoint #7: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 80/40 Versus Placebo). | Mucosal healing defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration) | Week 8 |
| Ranked Secondary Endpoint #8: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo). | Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed | Week 8 |
| Ranked Secondary Endpoint #9: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo). | The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3) | Week 8 |
| Ranked Secondary Endpoint #10: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo). | Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal | Week 8 |
| Ranked Secondary Endpoint #11: Proportion of IBDQ Responders at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Week 8 |
| Ranked Secondary Endpoint #12: Proportion of IBDQ Responders at Week 8 (Adalimumab 80/40 Versus Placebo). | Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Week 8 |
| Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 | Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | Week 52 |
| Proportion of Participants With Clinical Remission Per Partial Mayo Score at Week 52 | Clinical remission per partial Mayo score is defined as a partial Mayo score <= 2 and no individual subscore > 1. The partial Mayo score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | Week 52 |
| Proportion of Participants With Clinical Response Per Mayo Score at Week 52 | Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | Week 52 |
| Proportion of Participants With Clinical Response Per Partial Mayo Score at Week 52 | Clinical response per partial Mayo score is defined as a decrease in partial Mayo score of >= 2 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1. The partial Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | Week 52 |
| Proportion of Participants With Mucosal Healing at Week 52 | Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration) | Week 52 |
| Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 52 | Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed | Week 52 |
| Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 52 | The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3) | Week 52 |
| Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 52 | Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal | Week 52 |
| Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 Among Participants Who Were Systemic Corticosteroid-free at Week 52 | Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | Week 52 |
| Mobile |
| Alabama |
| 36617 |
| United States |
| Site Ref # / Investigator 5100 | Fayetteville | Arkansas | 72703 | United States |
| Site Ref # / Investigator 5390 | Orange | California | 92868 | United States |
| Site Ref # / Investigator 5392 | San Diego | California | 92123 | United States |
| Site Ref # / Investigator 2245 | Bridgeport | Connecticut | 06606 | United States |
| Site Ref # / Investigator 2240 | Gainesville | Florida | 32610 | United States |
| Site Ref # / Investigator 2230 | South Miami | Florida | 33143 | United States |
| Site Ref # / Investigator 5393 | Atlanta | Georgia | 30308 | United States |
| Site Ref # / Investigator 2231 | Atlanta | Georgia | 30342 | United States |
| Site Ref # / Investigator 2498 | Chicago | Illinois | 60637 | United States |
| Site Ref # / Investigator 2078 | Chevy Chase | Maryland | 20815 | United States |
| Site Ref # / Investigator 2238 | Silver Springs | Maryland | 20901 | United States |
| Site Ref # / Investigator 1971 | Boston | Massachusetts | 02114 | United States |
| Site Ref # / Investigator 2246 | Rochester | Minnesota | 55905 | United States |
| Site Ref # / Investigator 2243 | Kansas City | Missouri | 64131 | United States |
| Site Ref # / Investigator 2247 | Mexico | Missouri | 65265 | United States |
| Site Ref # / Investigator 2233 | Lincoln | Nebraska | 68503 | United States |
| Site Ref # / Investigator 2236 | Cedar Knolls | New Jersey | 07927 | United States |
| Site Ref # / Investigator 2072 | New York | New York | 10028 | United States |
| Site Ref # / Investigator 2241 | Charlotte | North Carolina | 28211 | United States |
| Site Ref # / Investigator 2232 | Raleigh | North Carolina | 27612 | United States |
| Site Ref # / Investigator 11801 | Wilmington | North Carolina | 28403 | United States |
| Site Ref # / Investigator 2074 | Cincinnati | Ohio | 45219 | United States |
| Site Ref # / Investigator 2126 | Cleveland | Ohio | 44106-5066 | United States |
| Site Ref # / Investigator 6090 | Germantown | Tennessee | 38138 | United States |
| Site Ref # / Investigator 2076 | Nashville | Tennessee | 37203 | United States |
| Site Ref # / Investigator 2229 | Bellevue | Washington | 98004 | United States |
| Site Ref # / Investigator 2077 | Milwaukee | Wisconsin | 53215 | United States |
| Site Ref # / Investigator 4936 | Graz | 8036 | Austria |
| Site Ref # / Investigator 6224 | Hall in Tirol | 6060 | Austria |
| Site Ref # / Investigator 3830 | Innsbruck | A-6020 | Austria |
| Site Ref # / Investigator 7508 | Linz | A-4010 | Austria |
| Site Ref # / Investigator 3829 | Salzburg | A-5020 | Austria |
| Site Ref # / Investigator 4937 | Vienna | 1030 | Austria |
| Site Ref # / Investigator 3831 | Vienna | 1090 | Austria |
| Site Ref # / Investigator 3861 | Bonheiden | 2820 | Belgium |
| Site Ref # / Investigator 3859 | Liège | 4000 | Belgium |
| Site Ref # / Investigator 3862 | Roeselare | 8800 | Belgium |
| Site Ref # / Investigator 2224 | Calgary | Alberta | T2N 4Z6 | Canada |
| Site Ref # / Investigator 2227 | Edmonton | Alberta | T6G 2X8 | Canada |
| Site Ref # / Investigator 2226 | Vancouver | British Columbia | V6Z-2K5 | Canada |
| Site Ref # / Investigator 2223 | Winnipeg | Manitoba | R3A 1R9 | Canada |
| Site Ref # / Investigator 2138 | Toronto | Ontario | M3N 2V7 | Canada |
| Site Ref # / Investigator 3858 | Brno | 62500 | Czechia |
| Site Ref # / Investigator 3856 | Olomouc | 77520 | Czechia |
| Site Ref # / Investigator 3857 | Ostrava | 708 52 | Czechia |
| Site Ref # / Investigator 3854 | Prague | 118 83 | Czechia |
| Site Ref # / Investigator 3855 | Prague | 17000 | Czechia |
| Site Ref # / Investigator 3832 | Berlin | 13353 | Germany |
| Site Ref # / Investigator 13983 | Essen | D-45239 | Germany |
| Site Ref # / Investigator 3834 | Jena | 07747 | Germany |
| Site Ref # / Investigator 3833 | Kiel | 24105 | Germany |
| Site Ref # / Investigator 3878 | Mainz | 55131 | Germany |
| Site Ref # / Investigator 3897 | Munich | 81377 | Germany |
| Site Ref # / Investigator 3852 | Budapest | H-1076 | Hungary |
| Site Ref # / Investigator 3850 | Budapest | H-1125 | Hungary |
| Site Ref # / Investigator 3849 | Győr | H-9024 | Hungary |
| Site Ref # / Investigator 3876 | Bologna | 40138 | Italy |
| Site Ref # / Investigator 3848 | Milan | 20157 | Italy |
| Site Ref # / Investigator 3845 | Palermo | 90146 | Italy |
| Site Ref # / Investigator 6232 | Rome | 00133 | Italy |
| Site Ref # / Investigator 3846 | Rome | 00152 | Italy |
| Site Ref # / Investigator 3873 | Eindhoven | 5623 EJ | Netherlands |
| Site Ref # / Investigator 3875 | Leiden | 2333 ZA | Netherlands |
| Site Ref # / Investigator 8061 | Lodz | 90-153 | Poland |
| Site Ref # / Investigator 13804 | Sopot | 81-756 | Poland |
| Site Ref # / Investigator 8055 | Warsaw | 02-507 | Poland |
| Site Ref # / Investigator 2392 | Ponce | 00717 | Puerto Rico |
| Site Ref # / Investigator 2393 | San Juan | 00936-5067 | Puerto Rico |
| Site Ref # / Investigator 3839 | Banská Bystrica | 97 401 | Slovakia |
| Site Ref # / Investigator 3838 | Bratislava | 811 07 | Slovakia |
| Site Ref # / Investigator 3841 | Bratislava | 833 05 | Slovakia |
| Site Ref # / Investigator 3842 | Nitra | 94 901 | Slovakia |
| Site Ref # / Investigator 14721 | Prešov | 08001 | Slovakia |
| Site Ref # / Investigator 14521 | Trenčín | 91101 | Slovakia |
| Site Ref # / Investigator 3840 | Trnava | 917 01 | Slovakia |
| Site Ref # / Investigator 8503 | Gothenburg | 41345 | Sweden |
| Site Ref # / Investigator 8504 | Linköping | 581 85 | Sweden |
| Site Ref # / Investigator 8502 | Lund | 22185 | Sweden |
| 23665965 | Derived | Reinisch W, Sandborn WJ, Panaccione R, Huang B, Pollack PF, Lazar A, Thakkar RB. 52-week efficacy of adalimumab in patients with moderately to severely active ulcerative colitis who failed corticosteroids and/or immunosuppressants. Inflamm Bowel Dis. 2013 Jul;19(8):1700-9. doi: 10.1097/MIB.0b013e318281f2b7. |
| 21209123 | Derived | Reinisch W, Sandborn WJ, Hommes DW, D'Haens G, Hanauer S, Schreiber S, Panaccione R, Fedorak RN, Tighe MB, Huang B, Kampman W, Lazar A, Thakkar R. Adalimumab for induction of clinical remission in moderately to severely active ulcerative colitis: results of a randomised controlled trial. Gut. 2011 Jun;60(6):780-7. doi: 10.1136/gut.2010.221127. Epub 2011 Jan 5. |
Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. |
| FG002 | Adalimumab 160/80/40 | Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. |
| COMPLETED |
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| NOT COMPLETED |
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| Efficacy Analysis Set - Maintenance |
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| Safety Analysis Set |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3). |
| BG001 | Adalimumab 80/40 | Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. |
| BG002 | Adalimumab 160/80/40 | Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Proportion of Participants With Clinical Remission Per Mayo Score at Week 8 | Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #1: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #2: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration) | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #3: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #4: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo). | The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3) | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #5: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #6: Proportion of Participants With Clinical Response Per Mayo Score at Week 8 (Adalimumab 80/40 Versus Placebo). | Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #7: Proportion of Participants With Mucosal Healing at Week 8 (Adalimumab 80/40 Versus Placebo). | Mucosal healing defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration) | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #8: Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo). | Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #9: Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo). | The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3) | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #10: Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 8 (Adalimumab 80/40 Versus Placebo). | Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #11: Proportion of IBDQ Responders at Week 8 (Adalimumab 160/80/40 Versus Placebo). | Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Ranked Secondary Endpoint #12: Proportion of IBDQ Responders at Week 8 (Adalimumab 80/40 Versus Placebo). | Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) defined as a >= 16-point increase from Baseline in total IBDQ score. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | All participants enrolled after Amendment 3 to the study protocol (which introduced the adalimumab 80/40 treatment arm) and who received at least 1 dose of study drug were included in this intent-to-treat (ITT) analysis. Nonresponder imputation (NRI) was used. | Posted | Number | Proportion of participants | Week 8 |
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| Secondary | Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 | Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation. | Posted | Number | Proportion of participants | Week 52 |
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| Secondary | Proportion of Participants With Clinical Remission Per Partial Mayo Score at Week 52 | Clinical remission per partial Mayo score is defined as a partial Mayo score <= 2 and no individual subscore > 1. The partial Mayo score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation. | Posted | Number | Proportion of participants | Week 52 |
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| Secondary | Proportion of Participants With Clinical Response Per Mayo Score at Week 52 | Clinical response per Mayo score is defined as a decrease in Mayo score of >= 3 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation. | Posted | Number | Proportion of participants | Week 52 |
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| Secondary | Proportion of Participants With Clinical Response Per Partial Mayo Score at Week 52 | Clinical response per partial Mayo score is defined as a decrease in partial Mayo score of >= 2 points and >= 30% from Baseline, plus either a decrease in rectal bleeding subscore of >= 1 point or an absolute rectal bleeding subscore of 0 or 1. The partial Mayo Score is a discrete ordinal scale ranging from 0 (normal or inactive disease) to 9 (severe disease) and is a composite of 3 subscores: Stool Frequency Subscore, Rectal Bleeding Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; subjects who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation. | Posted | Number | Proportion of participants | Week 52 |
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| Secondary | Proportion of Participants With Mucosal Healing at Week 52 | Mucosal healing is defined as Endoscopy Subscore of 0 or 1 as assessed by flexible sigmoidoscopy. Possible scores range from 0-3 as follows: 0 = Normal or inactive disease, 1 = Mild disease (erythema, decreased vascular pattern, mild friability), 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions), 3 = Severe disease (spontaneous bleeding, ulceration) | All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation. | Posted | Number | Proportion of participants | Week 52 |
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| Secondary | Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (<= 1) at Week 52 | Rectal Bleeding Subscore ranges from 0-3 as follows: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, 3 = blood alone passed | All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation. | Posted | Number | Proportion of participants | Week 52 |
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| Secondary | Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (<= 1) at Week 52 | The Physician's Global Assessment Subscore acknowledges the 3 other subscores (Stool Frequency, Rectal Bleeding, and Endoscopy), the subject's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the subject's performance status. Possible scores range from 0-3 as follows: 0 = Normal (other subscores are 0), 1 = Mild disease (other subscores are mostly 1), 2 = Moderate disease (other subscores are 1 to 2), 3 = Severe disease (other subscores are 2 to 3) | All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation. | Posted | Number | Proportion of participants | Week 52 |
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| Secondary | Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (<= 1) at Week 52 | Stool Frequency Subscore ranges from 0-3 as follows: 0 = Normal number of stools for this participant, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal | All randomized participants (enrolled under any version of the protocol) who received at least 1 dose of study drug were included in this intent-to-treat analysis. Nonresponder imputation (NRI) was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders after their dose escalation. | Posted | Number | Proportion of participants | Week 52 |
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| Secondary | Proportion of Participants With Clinical Remission Per Mayo Score at Week 52 Among Participants Who Were Systemic Corticosteroid-free at Week 52 | Clinical remission per Mayo score is defined as a total Mayo score <= 2 and no individual subscore > 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, Rectal Bleeding Subscore, Endoscopy Subscore, and Physician's Global Assessment Subscore, each of which ranges from 0 (normal) to 3 (severe disease). | All randomized participants enrolled under any version of the protocol who took systemic corticosteroids (CS) at Baseline, received at least 1 dose of study drug, and were systemic CS-free at Week 52 were included. Nonresponder imputation was used; participants who dose escalated to adalimumab 40 mg ew were considered nonresponders post-escalation. | Posted | Number | Proportion of participants | Week 52 |
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Adverse event data are presented through Week 8 for the placebo, adalimumab 80/40, and adalimumab 160/80/40 groups. Adverse event data are presented through Week 52 for the Any Adalimumab group.
Adverse events reported in the "Any Adalimumab" group include those reported in the "Adalimumab 80/40" and "Adalimumab 160/80/40" groups (during the double-blind phase) plus adverse events reported during open-label adalimumab treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Treatment group received placebo at Weeks 0, 2, 4, and 6. Adverse events include those reported prior to dosing at Week 8. | 17 | 223 | 34 | 223 | ||
| EG001 | Adalimumab 80/40 | Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8. | 5 | 130 | 30 | 130 | ||
| EG002 | Adalimumab 160/80/40 | Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8. | 9 | 223 | 34 | 223 | ||
| EG003 | Any Adalimumab | Treatment group received at least 1 dose of adalimumab during the study. Adverse events include those reported from the first dose of adalimumab during the double-blind or open-label period. | 76 | 557 | 210 | 557 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 12.1 | Systematic Assessment |
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| Hyperthyroidism | Endocrine disorders | MedDRA 12.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | As this was a study in subjects with ulcerative colitis as the underlying disease, the event term of "colitis ulcerative" refers to worsening of the disease (i.e., flare). |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Duodenal ulcer perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Mesenteric vein thrombosis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 12.1 | Systematic Assessment |
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| Abdominal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Abscess rupture | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Cytomegalovirus colitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Gastroenteritis rotavirus | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Hepatitis A | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Herpes zoster ophthalmic | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Perirectal abscess | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Pneumonia legionella | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 12.1 | Systematic Assessment |
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| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Electrolyte imbalance | Metabolism and nutrition disorders | MedDRA 12.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Spindle cell sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Leukoencephalopathy | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Personality disorder | Psychiatric disorders | MedDRA 12.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Abortion induced | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
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| Nasal septal operation | Surgical and medical procedures | MedDRA 12.1 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| Thrombosis | Vascular disorders | MedDRA 12.1 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Wound infection staphylococcal | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA 12.1 | Systematic Assessment |
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| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | Systematic Assessment |
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| Bladder prolapse | Renal and urinary disorders | MedDRA 12.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment | As this was a study in subjects with ulcerative colitis as the underlying disease, the event term of "colitis ulcerative" refers to worsening of the disease (i.e., flare). |
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| Headache | Nervous system disorders | MedDRA 12.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 12.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 12.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 | Systematic Assessment |
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Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided
| Lost to Follow-up |
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| Lack of Efficacy |
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| Protocol Violation |
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| Other |
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| Lost to Follow-up |
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| Lack of Efficacy |
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| Protocol Violation |
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| Other |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Slovakia |
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| Austria |
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| Italy |
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| Czech Republic |
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| Hungary |
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| Canada |
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| Belgium |
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| Poland |
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| Germany |
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| Netherlands |
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| Sweden |
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| Chi-squared |
| 0.833 |
The primary endpoint analysis was carried out in hierarchical order (as presented) to handle the multiplicity issues induced by the two adalimumab groups being compared to placebo and to control the overall alpha level of 0.05. |
| 95 |
| No |
| Superiority or Other |
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