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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002782-40 | EudraCT Number |
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This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with moderately to severely active ulcerative colitis (UC).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adalimumab group | Experimental |
| |
| placebo group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | Prefilled syringe, 40 mg, 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week between Weeks 4 and 50. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). |
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Inclusion Criteria:
Participants >=18 years of age and in good health (Investigator discretion) with a recent stable medical history
Diagnosis of UC for greater than 90 days prior to Baseline
Diagnosis of active UC 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 (AZA or 6-MP) during the past 5 years and in the judgment of the Investigator have failed to respond to, or could not tolerate, their treatment.
Participants may have been included if they had previously used an anti-tumor necrosis factor (TNF) agent (except ADA) and discontinued its use due to a loss of response or intolerance to the agent.
Had to be able to self-administer or had caregiver who could reliably administer subcutaneous (SC) injections.
Had to be able and willing to give written informed consent and to comply with the requirements of the 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 the last dose of study drug. Examples of approved methods of birth control included the following:
Judged to be in generally good health as determined by the Investigator
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roopal B Thakkar, M.D. | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 5394 | Anaheim | California | 92801 | United States | ||
| Site Ref # / Investigator 3753 |
| 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. | |
| 25041859 | Derived | Wolf D, D'Haens G, Sandborn WJ, Colombel JF, Van Assche G, Robinson AM, Lazar A, Zhou Q, Petersson J, Thakkar RB. Escalation to weekly dosing recaptures response in adalimumab-treated patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2014 Sep;40(5):486-97. doi: 10.1111/apt.12863. Epub 2014 Jul 15. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab 160/80/40 | During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg). |
| FG001 | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| placebo | Biological | Matching Placebo for prefilled syringe, 40 mg, |
|
| Week 8, Week 52 |
| Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8 | Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Week 8 |
| Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52 | Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Week 52 |
| Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52 | Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Week 8, Week 52 |
| Proportion of Participants Who Achieved Mucosal Healing at Week 8 | Mucosal healing is defined as an 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 |
| Proportion of Participants Who Achieved Mucosal Healing at Week 52 | Mucosal healing is defined as an 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 Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52 | Mucosal healing is defined as an 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, Week 52 |
| Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Baseline to Week 52 |
| Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 | The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant'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 |
| Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 | SFS 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. The participant served as his/her own control. | Week 8 |
| Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 | RBS 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 |
| Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Baseline to Week 52 |
| Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Week 32, Week 52 |
| Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52 | Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least 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 questions 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 52 |
| Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8 | Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least 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 questions 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 |
| Wheat Ridge |
| Colorado |
| 80033 |
| United States |
| Site Ref # / Investigator 3754 | Hamden | Connecticut | 06518 | United States |
| Site Ref # / Investigator 12903 | Gainesville | Florida | 32607 | United States |
| Site Ref # / Investigator 3747 | Hollywood | Florida | 33021 | United States |
| Site Ref # / Investigator 5106 | Jacksonville | Florida | 32256 | United States |
| Site Ref # / Investigator 11601 | Naples | Florida | 34102 | United States |
| Site Ref # / Investigator 6846 | Sarasota | Florida | 34239 | United States |
| Site Ref # / Investigator 3742 | Winter Park | Florida | 32789 | United States |
| Site Ref # / Investigator 3760 | Zephyrhills | Florida | 33542 | United States |
| Site Ref # / Investigator 3739 | Atlanta | Georgia | 30342 | United States |
| Site Ref # / Investigator 7658 | Macon | Georgia | 31201 | United States |
| Site Ref # / Investigator 5397 | Moline | Illinois | 61265 | United States |
| Site Ref # / Investigator 7453 | Topeka | Kansas | 66606 | United States |
| Site Ref # / Investigator 3759 | Annapolis | Maryland | 21401 | United States |
| Site Ref # / Investigator 3762 | Annapolis | Maryland | 21401 | United States |
| Site Ref # / Investigator 3738 | Lutherville | Maryland | 21093 | United States |
| Site Ref # / Investigator 7472 | Troy | Michigan | 48098 | United States |
| Site Ref # / Investigator 3744 | Rochester | Minnesota | 55905 | United States |
| Site Ref # / Investigator 6088 | St Louis | Missouri | 63128 | United States |
| Site Ref # / Investigator 3756 | Great Neck | New York | 11021 | United States |
| Site Ref # / Investigator 3752 | Charlotte | North Carolina | 28207 | United States |
| Site Ref # / Investigator 3758 | Jacksonville | North Carolina | 28546 | United States |
| Site Ref # / Investigator 3745 | Cincinnati | Ohio | 45219 | United States |
| Site Ref # / Investigator 7709 | Oklahoma City | Oklahoma | 73104 | United States |
| Site Ref # / Investigator 3740 | Tulsa | Oklahoma | 74104 | United States |
| Site Ref # / Investigator 3765 | Sayre | Pennsylvania | 18840 | United States |
| Site Ref # / Investigator 3741 | Columbia | South Carolina | 29204 | United States |
| Site Ref # / Investigator 3737 | Germantown | Tennessee | 38138 | United States |
| Site Ref # / Investigator 6077 | Nashville | Tennessee | 37203 | United States |
| Site Ref # / Investigator 5107 | Nashville | Tennessee | 37205 | United States |
| Site Ref # / Investigator 3743 | Nashville | Tennessee | 37212-1610 | United States |
| Site Ref # / Investigator 5398 | Ogden | Utah | 84405 | United States |
| Site Ref # / Investigator 8064 | Spokane | Washington | 99202 | United States |
| Site Ref # / Investigator 3750 | Spokane | Washington | 99204 | United States |
| Site Ref # / Investigator 3761 | West Bend | Wisconsin | 53095 | United States |
| Site Ref # / Investigator 6853 | Buenos Aires | C1181ACH | Argentina |
| Site Ref # / Investigator 13722 | Garran | Australian Capital Territory | 2605 | Australia |
| Site Ref # / Investigator 16141 | Bankstown | New South Wales | NSW 2200 | Australia |
| Site Ref # / Investigator 13723 | Herston | Queensland | 4029 | Australia |
| Site Ref # / Investigator 10706 | Bedford Park | South Australia | SA 5042 | Australia |
| Site Ref # / Investigator 14882 | Box Hill | Victoria | 3128 | Australia |
| Site Ref # / Investigator 9002 | Malvern | Victoria | 3144 | Australia |
| Site Ref # / Investigator 10704 | Fremantle | Western Australia | 6160 | Australia |
| Site Ref # / Investigator 9802 | Vienna | 1090 | Austria |
| Site Ref # / Investigator 5256 | Bonheiden | 2820 | Belgium |
| Site Ref # / Investigator 5253 | Brussels | 1070 | Belgium |
| Site Ref # / Investigator 6225 | Brussels | 1200 | Belgium |
| Site Ref # / Investigator 6079 | Ghent | 9000 | Belgium |
| Site Ref # / Investigator 6078 | Leuven | 3000 | Belgium |
| Site Ref # / Investigator 10423 | Kelowna | British Columbia | B1Y 1Z9 | Canada |
| Site Ref # / Investigator 3766 | Victoria | British Columbia | V8T 5G4 | Canada |
| Site Ref # / Investigator 13556 | Greater Sudbury | Ontario | P3E 2N8 | Canada |
| Site Ref # / Investigator 3769 | Hamilton | Ontario | L8N 3Z5 | Canada |
| Site Ref # / Investigator 3736 | Toronto | Ontario | M5G 1X5 | Canada |
| Site Ref # / Investigator 3771 | Montreal | Quebec | H3A 1A1 | Canada |
| Site Ref # / Investigator 3764 | Montreal | Quebec | H3G 1A4 | Canada |
| Site Ref # / Investigator 3768 | Montreal | Quebec | H3T 1E2 | Canada |
| Site Ref # / Investigator 3770 | Québec | Quebec | G1S 4L8 | Canada |
| Site Ref # / Investigator 7021 | České Budějovice | 370 87 | Czechia |
| Site Ref # / Investigator 6307 | Hradec Kravlove 12 | 500 12 | Czechia |
| Site Ref # / Investigator 6606 | Olomouc | 775 20 | Czechia |
| Site Ref # / Investigator 7481 | Prague | 140 21 | Czechia |
| Site Ref # / Investigator 7479 | Prague | 15006 | Czechia |
| Site Ref # / Investigator 6483 | Hvidovre | DK-2650 | Denmark |
| Site Ref # / Investigator 7477 | Odense C | 5000 | Denmark |
| Site Ref # / Investigator 6231 | Clichy | 92110 | France |
| Site Ref # / Investigator 7476 | Lille | 59037 | France |
| Site Ref # / Investigator 7475 | Pessac | 33600 | France |
| Site Ref # / Investigator 7474 | Toulouse | 31059 | France |
| Site Ref # / Investigator 15321 | Hamburg | 20148 | Germany |
| Site Ref # / Investigator 9069 | Hamburg | 22559 | Germany |
| Site Ref # / Investigator 14642 | Magdeburg | 39120 | Germany |
| Site Ref # / Investigator 9067 | Minden | 32423 | Germany |
| Site Ref # / Investigator 14661 | Munich | 80639 | Germany |
| Site Ref # / Investigator 9801 | Munich | 81377 | Germany |
| Site Ref # / Investigator 14761 | Münster | 48159 | Germany |
| Site Ref # / Investigator 5247 | Regensburg | 93053 | Germany |
| Site Ref # / Investigator 7485 | Budapest | H-1076 | Hungary |
| Site Ref # / Investigator 5025 | Budapest | H-1135 | Hungary |
| Site Ref # / Investigator 10625 | Debrecen | 4032 | Hungary |
| Site Ref # / Investigator 14104 | Gyula | 5700 | Hungary |
| Site Ref # / Investigator 4987 | Miskoic | H-3051 | Hungary |
| Site Ref # / Investigator 5036 | Miskolc | H-3526 | Hungary |
| Site Ref # / Investigator 12744 | Kfar Saba | 44281 | Israel |
| Site Ref # / Investigator 10623 | Petah Tikva | 49100 | Israel |
| Site Ref # / Investigator 15361 | Tel Aviv | 64239 | Israel |
| Site Ref # / Investigator 13301 | Auckland | 0620 | New Zealand |
| Site Ref # / Investigator 13181 | Auckland | 1148 | New Zealand |
| Site Ref # / Investigator 13148 | Christchurch | 8011 | New Zealand |
| Site Ref # / Investigator 13482 | Hamilton | New Zealand |
| Site Ref # / Investigator 9561 | Gjøvik | 2819 | Norway |
| Site Ref # / Investigator 5197 | Oslo | 0027 | Norway |
| Site Ref # / Investigator 6297 | Oslo | 0514 | Norway |
| Site Ref # / Investigator 5194 | Tromsø | 9038 | Norway |
| Site Ref # / Investigator 5193 | Trondheim | 7006 | Norway |
| Site Ref # / Investigator 5242 | Lodz | 90-153 | Poland |
| Site Ref # / Investigator 5266 | Warsaw | 02 781 | Poland |
| Site Ref # / Investigator 5265 | Warsaw | 02-507 | Poland |
| Site Ref # / Investigator 15263 | Wroclaw | 54-144 | Poland |
| Site Ref # / Investigator 5264 | Faro | 8000-386 | Portugal |
| Site Ref # / Investigator 7473 | Lisbon | 1150-314 | Portugal |
| Site Ref # / Investigator 5263 | Lisbon | 1769-001 | Portugal |
| Site Ref # / Investigator 5211 | Barcelona | 08036 | Spain |
| Site Ref # / Investigator 5212 | Madrid | 28040 | Spain |
| Site Ref # / Investigator 10221 | Basel | 4031 | Switzerland |
| Site Ref # / Investigator 10222 | Bern | 3010 | Switzerland |
| Site Ref # / Investigator 9162 | Zurich | 8091 | Switzerland |
| 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. |
| 23173821 | Derived | Sandborn WJ, Colombel JF, D'Haens G, Van Assche G, Wolf D, Kron M, Lazar A, Robinson AM, Yang M, Chao JD, Thakkar R. One-year maintenance outcomes among patients with moderately-to-severely active ulcerative colitis who responded to induction therapy with adalimumab: subgroup analyses from ULTRA 2. Aliment Pharmacol Ther. 2013 Jan;37(2):204-13. doi: 10.1111/apt.12145. Epub 2012 Nov 23. |
The placebo treatment group received placebo throughout the Double-Blind (DB) period. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab 160/80/40 | During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg). |
| BG001 | Placebo | The placebo treatment group received placebo throughout the Double-Blind (DB) period. |
| BG002 | 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 Continuous | The ITT analysis set, defined as all participants who were randomized in the study excluding participants from 3 non-compliant sites, was used to determine all Baseline measures (continuous age, customized age, gender, and region of enrollment). | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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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 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). | Intent-to-treat (ITT) analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label (OL) treatment were considered to be non-remission. | Posted | Jan 2011 | Number | Percentage of Participants | Week 8 |
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| Primary | Proportion of Participants Who Achieved Clinical Remission Per Mayo Score at Week 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to OL treatment were considered to be non-remission. | Posted | Jan 2011 | Number | Percentage of Participants | Week 52 |
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| Secondary | Proportion of Participants Who Achieved Sustained Clinical Remission Per Mayo Score at Both Week 8 and Week 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Jan 2011 | Number | Percentage of Participants | Week 8, Week 52 |
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| Secondary | Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 8 | Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in rectal bleeding subscore (RBS) of at least 1 point from Baseline or an absolute RBS 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Jan 2011 | Number | Percentage of Participants | Week 8 |
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| Secondary | Proportion of Participants Who Achieved Clinical Response Per Mayo Score at Week 52 | Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 52 |
|
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| Secondary | Proportion of Participants Who Achieved Sustained Clinical Response Per Mayo Score at Both Week 8 and Week 52 | Clinical response per Mayo score is defined as a decrease in Mayo score of at least 3 points and at least 30% from Baseline, plus either a decrease in RBS of at least 1 point from Baseline or an absolute RBS 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 8, Week 52 |
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| Secondary | Proportion of Participants Who Achieved Mucosal Healing at Week 8 | Mucosal healing is defined as an 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). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 8 |
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| Secondary | Proportion of Participants Who Achieved Mucosal Healing at Week 52 | Mucosal healing is defined as an 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). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 52 |
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| Secondary | Proportion of Participants Who Achieved Sustained Mucosal Healing at Both Week 8 and Week 52 | Mucosal healing is defined as an 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). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 8, Week 52 |
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| Secondary | Proportion of Participants Who Discontinued Corticosteroid Use Before Week 52 and Achieved Clinical Remission Per Mayo Score at Week 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Baseline to Week 52 |
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| Secondary | Proportion of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 | The PGA includes the 3 other subscores (SFS, RBS, and Endoscopy), the participant's daily record of abdominal discomfort and functional assessment, and other observations such as physical findings and the participant'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). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 8 |
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| Secondary | Proportion of Participants With Stool Frequency Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 | SFS 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. The participant served as his/her own control. | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 8 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (a Score of 0 or 1) at Week 8 | RBS 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 | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 8 |
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| Secondary | Proportion of Participants Who Discontinued Corticosteroid Use for At Least 90 Days and Achieved Clinical Remission Per Mayo Score at Week 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Baseline to Week 52 |
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| Secondary | Proportion of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission Per Mayo Score (Sustained) at Both Weeks 32 and 52 | 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: SFS, RBS, Endoscopy Subscore, and PGA, each of which ranges from 0 (normal) to 3 (severe disease). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 32, Week 52 |
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| Secondary | Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 52 | Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least 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 questions 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). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 52 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Proportion of Inflammatory Bowel Disease Questionnaire Responders at Week 8 | Response per the Inflammatory Bowel Disease Questionnaire (IBDQ) was defined as at least 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 questions 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). | Intent-to-treat analysis set using the non-responder imputation (NRI) method in which all missing remission values and values after switch to open-label treatment were considered to be non-remission. | Posted | Number | Percentage of Participants | Week 8 |
|
|
Double-Blind (DB) period: From 1st study drug dose in DB period to 70 days after last DB study drug dose or until switch to Open-Label. Any Adalimumab: From 1st adalimumab dose up 70 days after last adalimumab dose or until switch to extension study.
**518 participants were randomized into the study; 1 subject did not receive study drug and was excluded from the safety analyses. The number of participants in the Safety population (at least 1 dose of study drug) was higher (517) than that in the ITT population (494), as the latter excluded participants from 3 non-compliant clinical sites.**
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 | Adalimumab Group - Double-Blind Period | During the Double-Blind period, the Adalimumab treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg). | 31 | 257 | 139 | 257 | ||
| EG001 | Placebo Group - Double-Blind Period | The placebo treatment group received placebo throughout the Double-Blind period. | 32 | 260 | 142 | 260 | ||
| EG002 | Any Adalimumab | During the Double-Blind period, only the Adalimumab treatment group received active study drug (dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 [160/80/40 mg]). After the switch to open-label treatment, participants in both treatment groups received adalimumab 40 mg eow, unless they dose-escalated, in which case they received adalimumab 40 mg every week (ew). Consequently, this analysis set combined adalimumab exposure from both the Double-Blind and Open-Label periods. | 61 | 398 | 204 | 398 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 |
| ||
| Leukopenia | Blood and lymphatic system disorders | MedDRA 12.1 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Anal fistula | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Colitis | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Constipation | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Gastrointestinal dysplasia | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Crohn's disease | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Inguinal hernia | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Localized intraabdominal fluid collection | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Obstruction gastric | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Rectal perforation | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Non-cardiac chest pain | General disorders | MedDRA 12.1 |
| ||
| Cholelithiasis | Hepatobiliary disorders | MedDRA 12.1 |
| ||
| Anal abscess | Infections and infestations | MedDRA 12.1 |
| ||
| Appendicitis | Infections and infestations | MedDRA 12.1 |
| ||
| Catheter sepsis | Infections and infestations | MedDRA 12.1 |
| ||
| Cytomegalovirus colitis | Infections and infestations | MedDRA 12.1 |
| ||
| Erysipelas | Infections and infestations | MedDRA 12.1 |
| ||
| Herpes simplex | Infections and infestations | MedDRA 12.1 |
| ||
| Liver abscess | Infections and infestations | MedDRA 12.1 |
| ||
| Perineal abscess | Infections and infestations | MedDRA 12.1 |
| ||
| Pneumonia | Infections and infestations | MedDRA 12.1 |
| ||
| Pneumonia necrotizing | Infections and infestations | MedDRA 12.1 |
| ||
| Respiratory tract infection | Infections and infestations | MedDRA 12.1 |
| ||
| Salmonellosis | Infections and infestations | MedDRA 12.1 |
| ||
| Scrotal abscess | Infections and infestations | MedDRA 12.1 |
| ||
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 12.1 |
| ||
| Wound | Injury, poisoning and procedural complications | MedDRA 12.1 |
| ||
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 12.1 |
| ||
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA 12.1 |
| ||
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
| ||
| Ligament calcification | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
| ||
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
| ||
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 |
| ||
| Gastrointestinal tract adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 |
| ||
| Abortion | Pregnancy, puerperium and perinatal conditions | MedDRA 12.1 |
| ||
| Calculus ureteric | Renal and urinary disorders | MedDRA 12.1 |
| ||
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.1 |
| ||
| Renal failure acute | Renal and urinary disorders | MedDRA 12.1 |
| ||
| Cystocele | Reproductive system and breast disorders | MedDRA 12.1 |
| ||
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 12.1 |
| ||
| Organizing pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
| ||
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
| ||
| Dermatitis bullous | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
| ||
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
| ||
| Pyoderma gangrenosum | Skin and subcutaneous tissue disorders | MedDRA 12.1 |
| ||
| Deep vein thrombosis | Vascular disorders | MedDRA 12.1 |
| ||
| Orthostatic hypotension | Vascular disorders | MedDRA 12.1 |
| ||
| Thrombophlebitis superficial | Vascular disorders | MedDRA 12.1 |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 12.1 |
| ||
| Abdominal pain | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Nausea | Gastrointestinal disorders | MedDRA 12.1 |
| ||
| Fatigue | General disorders | MedDRA 12.1 |
| ||
| Pyrexia | General disorders | MedDRA 12.1 |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA 12.1 |
| ||
| Upper respiratory tract infection | Infections and infestations | MedDRA 12.1 |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12.1 |
| ||
| Headache | Nervous system disorders | MedDRA 12.1 |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 |
|
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
| 40 to 64 years |
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| >=65 years |
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| Norway |
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| Switzerland |
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