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| Name | Class |
|---|---|
| Eisai Co., Ltd. | INDUSTRY |
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The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).
Patients who meet all of the inclusion criteria and none of the exclusion criteria are randomized 1:1:1 to receive subcutaneous injections of adalimumab at either 160/80 mg at Week 0/2 and 40 mg every other week (eow) starting at Week 4 to Week 50, 80/40 mg at Week 0/2 and 40 mg eow starting at Week 4 to Week 50, or placebo eow starting at Week 0 to Week 50 under the double-blind condition. At or after Week 8, participants who have inadequate response during the double-blind period can switch to the rescue arm, where participants from the placebo group initially receive adalimumab 160 mg and 80 mg 2 weeks later and those from the adalimumab group receive adalimumab 40 mg initially and 2 weeks later under double-blind conditions. All participants in the rescue arm then receive 40 mg adalimumab eow until Week 50. Participants who complete the 52-week double-blind period receive open-label adalimumab 40 mg eow starting at Week 52 and continuing until the end of the study. Participants who have an inadequate response or disease flare can dose escalate to 80 mg eow at or after Week 60. Participants who dose escalate to 80 mg eow and continue to have an inadequate response or disease flare are withdrawn from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
| Adalimumab 80 mg/40 mg | Experimental | Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
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| Adalimumab 160 mg/80 mg | Experimental | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission at 8 Weeks | Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease. | Week 8 |
| Percentage of Participants With Clinical Remission at 52 Weeks | Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks | Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morio Ozawa, MS | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 47136 | Asahikawa | Japan | ||||
| Site Reference ID/Investigator# 47159 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-blind Placebo | Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Double-blind Period |
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| placebo | Drug |
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| Weeks 8, 32, and 52 |
| Percentage of Participants With a Clinical Response | A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease. | Baseline and Weeks 8, 32, and 52 |
| Percentage of Participants With Mucosal Healing | Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52. The endoscopy subscore ranges from zero to three 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). | Weeks 8, 32, and 52 |
| Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1) | Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale: 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. | Weeks 8, 32, and 52 |
| Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1) | The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, 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 zero to three 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). | Weeks 8, 32, and 52 |
| Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1) | Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale: 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. | Weeks 8, 32, and 52 |
| Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders | An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (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 the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Baseline and Weeks 8, 32, and 52 |
| Number of Participants With Adverse Events up to Week 8 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below. | 8 weeks |
| Number of Participants With Adverse Events up to Week 52 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below. | 52 weeks |
| Number of Participants With Adverse Events During the Adalimumab Treatment Period | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below. | 221 weeks |
| Chiba |
| Japan |
| Site Reference ID/Investigator# 47183 | Chikushino-shi | Japan |
| Site Reference ID/Investigator# 47135 | Fukuoka | Japan |
| Site Reference ID/Investigator# 47182 | Fukuoka | Japan |
| Site Reference ID/Investigator# 47124 | Hamamatsu | Japan |
| Site Reference ID/Investigator# 47130 | Hirakata-shi | Japan |
| Site Reference ID/Investigator# 47103 | Hirosaki | Japan |
| Site Reference ID/Investigator# 47131 | Hiroshima | Japan |
| Site Reference ID/Investigator# 47178 | Hiroshima | Japan |
| Site Reference ID/Investigator# 47179 | Hiroshima | Japan |
| Site Reference ID/Investigator# 47176 | Izumo | Japan |
| Site Reference ID/Investigator# 47226 | Kagoshima | Japan |
| Site Reference ID/Investigator# 47123 | Kanazawa | Japan |
| Site Reference ID/Investigator# 47160 | Kashiwa | Japan |
| Site Reference ID/Investigator# 47108 | Kawagoe | Japan |
| Site Reference ID/Investigator# 47107 | Koshigaya | Japan |
| Site Reference ID/Investigator# 47181 | Kurume | Japan |
| Site Reference ID/Investigator# 47222 | Kurume | Japan |
| Site Reference ID/Investigator# 47223 | Kurume | Japan |
| Site Reference ID/Investigator# 47127 | Kyoto | Japan |
| Site Reference ID/Investigator# 47170 | Kyoto | Japan |
| Site Reference ID/Investigator# 47171 | Kyoto | Japan |
| Site Reference ID/Investigator# 47172 | Kyoto | Japan |
| Site Reference ID/Investigator# 47134 | Matsuyama | Japan |
| Site Reference ID/Investigator# 47225 | Miyazaki | Japan |
| Site Reference ID/Investigator# 47138 | Morioka | Japan |
| Site Reference ID/Investigator# 47168 | Nagakute-shi | Japan |
| Site Reference ID/Investigator# 47125 | Nagoya | Japan |
| Site Reference ID/Investigator# 47126 | Nagoya | Japan |
| Site Reference ID/Investigator# 47166 | Nagoya | Japan |
| Site Reference ID/Investigator# 47122 | Niigata | Japan |
| Site Reference ID/Investigator# 47227 | Nishihara | Japan |
| Site Reference ID/Investigator# 47174 | Nishinomiya-shi | Japan |
| Site Reference ID/Investigator# 47177 | Okayama | Japan |
| Site Reference ID/Investigator# 47228 | Okinawa | Japan |
| Site Reference ID/Investigator# 47128 | Osaka | Japan |
| Site Reference ID/Investigator# 47129 | Osaka | Japan |
| Site Reference ID/Investigator# 47224 | ÅŒita | Japan |
| Site Reference ID/Investigator# 47169 | ÅŒtsu | Japan |
| Site Reference ID/Investigator# 47118 | Sagamihara-shi | Japan |
| Site Reference ID/Investigator# 47158 | Saitama-shi | Japan |
| Site Reference ID/Investigator# 47109 | Sakura | Japan |
| Site Reference ID/Investigator# 15853 | Sapporo | Japan |
| Site Reference ID/Investigator# 47137 | Sapporo | Japan |
| Site Reference ID/Investigator# 47104 | Sendai | Japan |
| Site Reference ID/Investigator# 47147 | Sendai | Japan |
| Site Reference ID/Investigator# 47180 | Susaki-shi | Japan |
| Site Reference ID/Investigator# 47133 | Takamatsu | Japan |
| Site Reference ID/Investigator# 47173 | Takatsuki-shi | Japan |
| Site Reference ID/Investigator# 47106 | Tokorozawa-shi | Japan |
| Site Reference ID/Investigator# 47132 | Tokushima | Japan |
| Site Reference ID/Investigator# 47110 | Tokyo | Japan |
| Site Reference ID/Investigator# 47111 | Tokyo | Japan |
| Site Reference ID/Investigator# 47112 | Tokyo | Japan |
| Site Reference ID/Investigator# 47116 | Tokyo | Japan |
| Site Reference ID/Investigator# 47117 | Tokyo | Japan |
| Site Reference ID/Investigator# 47161 | Tokyo | Japan |
| Site Reference ID/Investigator# 47164 | Tokyo | Japan |
| Site Reference ID/Investigator# 47165 | Toyama | Japan |
| Site Reference ID/Investigator# 47167 | Toyoake | Japan |
| Site Reference ID/Investigator# 47105 | Yamagata | Japan |
| Site Reference ID/Investigator# 47175 | Yamatotakada | Japan |
| Site Reference ID/Investigator# 47120 | Yokohama | Japan |
| Site Reference ID/Investigator# 47121 | Yokohama | Japan |
| Double-blind Adalimumab 80 mg/40 mg |
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. |
| FG002 | Double-blind Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. |
| FG003 | All Adalimumab | All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase). |
| Treated |
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| Completed Week 8 |
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| COMPLETED |
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| NOT COMPLETED |
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| Double-blind + Open-label Periods |
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1 participant in the adalimumab 160 mg/80 mg arm was incorrectly treated with open-label (rescue) study drug at Week 0, and was not included in Baseline Characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
| BG001 | Adalimumab 80 mg/40 mg | Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
| BG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
| 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, Continuous | Demographic data are provided for the Full Analysis Set (participants who received at least one dose of study drug in the double-blind portion of the study). | 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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| Mayo score | A composite score of ulcerative colitis disease activity calculated as the sum of 4 subscores:
| Mean | Standard Deviation | scores on a scale |
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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 | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Clinical Remission at 8 Weeks | Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease. | The full analysis set includes all patients who received at least 1 dose of study drug any time during the first 52 weeks and with at least 1 efficacy measurement after the first dose of study medication. Non-responder imputation (NRI) was used, where all missing values and values after the start of rescue treatment were considered non-remission. | Posted | Number | percentage of participants | Week 8 |
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| Primary | Percentage of Participants With Clinical Remission at 52 Weeks | Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease. | Full analysis set. Non-responder imputation (NRI) was used, where all missing remission values and values after the start of rescue treatment were considered as non-remission. | Posted | Number | percentage of participants | Week 52 |
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| Secondary | Percentage of Participants With Clinical Remission at 8, 32, and 52 Weeks | Clinical remission was defined as a Mayo score ≤ 2 with no individual subscore > 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease. | Full analysis set, non-responder imputation was used. | Posted | Number | percentage of participants | Weeks 8, 32, and 52 |
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| Secondary | Percentage of Participants With a Clinical Response | A clinical response was defined as a decrease in Mayo score of ≥ 3 points and ≥ 30% from Baseline PLUS a decrease in the Rectal Bleeding Subscore (RBS) ≥ 1 or an absolute RBS of 0 or 1. The Mayo score is a composite score of ulcerative colitis disease activity calculated as the sum of four subscores:
The total Mayo score ranges from 0 to 12 points, with higher scores representing more severe disease. | Full analysis set, non-responder imputation was used. | Posted | Number | percentage of participants | Baseline and Weeks 8, 32, and 52 |
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| Secondary | Percentage of Participants With Mucosal Healing | Mucosal healing was defined as an endoscopy subscore of ≤ 1 and was assessed using flexible sigmoidoscopy performed at Weeks 8, 32, and 52. The endoscopy subscore ranges from zero to three 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). | Full analysis set, non-responder imputation was used. | Posted | Number | percentage of participants | Weeks 8, 32, and 52 |
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| Secondary | Percentage of Participants With Rectal Bleeding Subscore Indicative of Mild Disease (≤ 1) | Rectal bleeding was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The rectal bleeding subscore ranges from zero to three, according to the following scale: 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. | Full analysis set, non-responder imputation was used. | Posted | Number | percentage of participants | Weeks 8, 32, and 52 |
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| Secondary | Percentage of Participants With Physician's Global Assessment Subscore Indicative of Mild Disease (≤ 1) | The Physician's Global Assessment Subscore acknowledges the three other subscores (Stool Frequency, Rectal Bleeding, 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 zero to three 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). | Full analysis set, non-responder imputation was used. | Posted | Number | percentage of participants | Weeks 8, 32, and 52 |
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| Secondary | Percentage of Participants With Stool Frequency Subscore Indicative of Mild Disease (≤ 1) | Stool frequency was assessed from the participant's diary, taking the worst score from the 3 days prior to each study visit. The stool frequency subscore ranges from zero to three, according to the following scale: 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. | Full analysis set, non-responder imputation was used. | Posted | Number | percentage of participants | Weeks 8, 32, and 52 |
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| Secondary | Percentage of Inflammatory Bowel Disease Questionnaire (IBDQ) Responders | An inflammatory bowel disease questionnaire responder was defined as a participant with at least a 16-point increase from Baseline in total Inflammatory Bowel Disease Questionnaire (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 the total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Full analysis set, non-responder imputation was used. | Posted | Number | percentage of participants | Baseline and Weeks 8, 32, and 52 |
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| Secondary | Number of Participants With Adverse Events up to Week 8 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below. | The Safety Analysis Set includes all participants who received at least one dose of study medication. | Posted | Number | participants | 8 weeks |
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| Secondary | Number of Participants With Adverse Events up to Week 52 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below. | The safety analysis set. | Posted | Number | participants | 52 weeks |
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| Secondary | Number of Participants With Adverse Events During the Adalimumab Treatment Period | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. For more details on adverse events please see the Adverse Event section below. | The safety analysis set. | Posted | Number | participants | 221 weeks |
|
|
For the 3 randomized treatment arms, adverse events (AEs) were reported from the time of study drug administration up to Week 52 (double-blind period); for All Adalimumab, AEs were reported up to 221 weeks+70 days following discontinuation of study drug.
Serious AEs (SAEs) were collected from the time participants signed the study-specific informed consent. For SAEs, the number of participants affected in the Double-blind Placebo arm (n=13) is reported from the final database lock, versus the number reported in Outcome Measure 11 (n=12), which was from the interim database lock.
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 | Double-blind Placebo | Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. | 13 | 96 | 51 | 96 | ||
| EG001 | Double-blind Adalimumab 80 mg/40 mg | Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. | 14 | 87 | 47 | 87 | ||
| EG002 | Double-blind Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. | 10 | 90 | 60 | 90 | ||
| EG003 | All Adalimumab | All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase). | 90 | 266 | 235 | 266 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ATRIAL FLUTTER | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PERICARDITIS | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SUPRAVENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| VENTRICULAR TACHYCARDIA | Cardiac disorders | MedDRA 15.1 | Systematic Assessment |
| |
| SUDDEN HEARING LOSS | Ear and labyrinth disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIABETIC RETINOPATHY | Eye disorders | MedDRA 15.1 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| COLONIC POLYP | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| GASTROINTESTINAL DYSPLASIA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INTESTINAL POLYP | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| PANCREATITIS ACUTE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RECTAL STENOSIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
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| RECTAL ULCER HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ADVERSE DRUG REACTION | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DEATH | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DRUG INTOLERANCE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| APPENDICITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BACTERIAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| BURSITIS INFECTIVE | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| CYTOMEGALOVIRUS INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ENTERITIS INFECTIOUS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ERYSIPELAS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| GINGIVITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PELVIC ABSCESS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PNEUMONIA BACTERIAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PSEUDOMEMBRANOUS COLITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PYELONEPHRITIS ACUTE | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| TUBERCULOSIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| HAND FRACTURE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| HEAT ILLNESS | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| INTENTIONAL OVERDOSE | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| LIGAMENT INJURY | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| WOUND | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
| |
| DRUG LEVEL | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| MEDICAL OBSERVATION | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| JOINT RANGE OF MOTION DECREASED | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MUSCLE HAEMORRHAGE | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PERIARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| CERVIX CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| PANCREATIC CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| PARATHYROID TUMOUR | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| RECTAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| THYROID CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| UTERINE LEIOMYOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
| |
| CEREBRAL HAEMORRHAGE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| EPILEPSY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CALCULUS URETERIC | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| TUBULOINTERSTITIAL NEPHRITIS | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| CERVICAL DYSPLASIA | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ERYTHEMA NODOSUM | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| IMMUNOSUPPRESSANT DRUG THERAPY | Surgical and medical procedures | MedDRA 15.1 | Systematic Assessment |
| |
| TAKAYASU'S ARTERITIS | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| DENTAL CARIES | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| STOMATITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INJECTION SITE REACTION | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| MALAISE | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| INFLUENZA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| ORAL HERPES | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
| |
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
| |
| INSOMNIA | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFLAMMATION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
| |
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
| |
| HYPERTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, 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
| Adverse Event |
|
| Withdrawal by Subject |
|
| Other |
|
| Male |
|
| OG001 | Adalimumab 80 mg/40 mg | Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
| Adalimumab 80 mg/40 mg |
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
| OG001 | Adalimumab 80 mg/40 mg | Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
| Adalimumab 80 mg/40 mg |
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
| OG002 | Adalimumab 160 mg/80 mg | Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval. |
|
|
|
|