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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000930-37 | EudraCT Number |
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Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ravagalimab 600 mg/300 mg | Experimental | Participants received ravagalimab 600 mg intravenous (IV) at Week 0 followed by ravagalimab 300 mg subcutaneously (SC) at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ravagalimab 600 mg | Drug | Ravagalimab 600 mg was administered intravenously (IV). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Endoscopic Improvement During Induction Period | Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer. | At Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period | Clinical remission per Adapted Mayo score is defined as stool frequency subscore (SFS) <=1, and not greater than baseline, rectal bleeding subscore (RBS) = 0, and endoscopic subscore <=1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore confirmed by central reader, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Banner University Medical Cent /ID# 208392 | Tucson | Arizona | 85724 | United States | ||
| Meridian Investigator Network /ID# 204646 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41920263 | Derived | Peyrin-Biroulet L, Seenan JP, Armuzzi A, Lazar A, Eldred A, Doan T, Polakow SB, Al Mahi N, Liu M, Nader A, Bhatnagar S, Schreiber S. Efficacy and Safety of Ravagalimab in Patients with Moderate-to-Severe Ulcerative Colitis: Data from a Phase 2a Trial. Adv Ther. 2026 Jun;43(6):2611-2630. doi: 10.1007/s12325-026-03517-3. Epub 2026 Apr 1. |
| Label | URL |
|---|---|
| Related Info | View source |
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AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
Prior to protocol version 4.0 this study was placebo-controlled. No participants were enrolled in the placebo group and therefore no results are presented for this arm.
A total of 42 participants were enrolled in the Induction Period to receive ravagalimab 600 mg intravenously (IV) followed by ravagalimab 300 mg subcutaneously (SC) up to Week 12. Participants who completed the Induction Period and achieved clinical response per partial adapted Mayo score at Week 12 entered the Maintenance Period to receive ravagalimab 300 mg SC up to Week 102.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ravagalimab 600 mg/300 mg | Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC every other week (EOW) from Week 12 through Week 102. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Induction Period (Week 0 to Week 12) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 4, 2020 | Jan 9, 2023 |
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| Ravagalimab 300 mg | Drug | Ravagalimab 300 mg was administered subcutaneously (SC). |
|
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| At Week 8 |
| Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period | Clinical response per Adapted Mayo score is defined as the decrease from Baseline >= 2 points and >= 30%, PLUS a decrease in RBS >=1 or an absolute RBS <=1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer. | At Week 8 |
| Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score | Clinical response per Partial Adapted Mayo score is defined as decrease from baseline >=1 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer. | Up to Week 8 |
| Percentage of Participants With Clinical Remission Per Full Mayo Score During Induction Period in Participants With a Full Mayo Score of 6 to 12 at Baseline | Clinical Remission per full Mayo score is defined as Full Mayo score <=2 with no subscore > 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Endoscopies were assessed by a central reader. Negative changes indicate improvement. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer. | At Week 8 |
| Percentage of Participants With Endoscopic Remission During Induction Period | Endoscopic remission is defined as Mayo endoscopic subscore = 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer. | At Week 8 |
| Huntington Beach |
| California |
| 92648-5994 |
| United States |
| Meridian Investigator Network /ID# 218568 | Lakewood | California | 90712 | United States |
| TLC Clinical Research Inc /ID# 206626 | Los Angeles | California | 90048 | United States |
| Orange County Institute of Gastroenterology and Endoscopy /ID# 207405 | Mission Viejo | California | 92691-6306 | United States |
| UC Davis Medical Center /ID# 209402 | Sacramento | California | 95817 | United States |
| The University of Chicago DCAM /ID# 207086 | Chicago | Illinois | 60637 | United States |
| Affinity Clinical Research /ID# 206211 | Oak Brook | Illinois | 60523-1245 | United States |
| Univ New Mexico /ID# 208817 | Albuquerque | New Mexico | 87131 | United States |
| Penn Presbyterian Medical Center /ID# 206826 | Philadelphia | Pennsylvania | 19104-2640 | United States |
| Vanderbilt University Medical Center /ID# 204670 | Nashville | Tennessee | 37232-0011 | United States |
| Clinical Associates in Research Therapeutics of America, LLC /ID# 204689 | San Antonio | Texas | 78212 | United States |
| Mount Sinai Hospital /ID# 206180 | Toronto | Ontario | M5G 1X5 | Canada |
| Chu de Nice-Hopital L'Archet Ii /Id# 208131 | Nice | Alpes-Maritimes | 06200 | France |
| CHRU Nancy - Hôpitaux de Brabois /ID# 208133 | Vandœuvre-lès-Nancy | Meurthe-et-Moselle | 54500 | France |
| Hopital Beaujon /ID# 208129 | Clichy | ÃŽle-de-France Region | 92110 | France |
| Universitaetsklinikum Frankfurt /ID# 207569 | Frankfurt am Main | Hesse | 60590 | Germany |
| Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 207571 | Kiel | Schleswig-Holstein | 24105 | Germany |
| Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 207570 | Berlin | 10117 | Germany |
| Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont /ID# 221576 | Szeged | Csongrád megye | 6725 | Hungary |
| Debreceni Egyetem Klinikai Kozpont /ID# 221952 | Debrecen | 4032 | Hungary |
| University of Catanzaro /ID# 204546 | Catanzaro | Calabria | 88100 | Italy |
| Presidio Columbus-Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Un /ID# 204549 | Rome | Roma | 00168 | Italy |
| Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 208504 | Milan | 20122 | Italy |
| Maastricht Universitair Medisch Centrum /ID# 204428 | Maastricht | 6229 HX | Netherlands |
| Franciscus Gasthuis & Vlietland /ID# 206976 | Rotterdam | 3045 PM | Netherlands |
| Elisabeth Tweesteden Ziekenhuis /ID# 206272 | Tilburg | 5022 GC | Netherlands |
| Kyungpook National University Hospital /ID# 209912 | Daegu | 41944 | South Korea |
| Yeungnam University Medical Center /ID# 210447 | Daegu | 42415 | South Korea |
| Hospital Santa Creu i Sant Pau /ID# 213259 | Barcelona | 08041 | Spain |
| Hospital General Universitario Gregorio Maranon /ID# 204504 | Madrid | 28007 | Spain |
| Hospital Universitario La Paz /ID# 210065 | Madrid | 28046 | Spain |
| NHS Greater Glasgow and Clyde /ID# 206574 | Glasgow | Scotland | G12 0XH | United Kingdom |
| Belfast Health and Social Care Trust /ID# 206744 | Belfast | BT9 7AB | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| Maintenance Period (Week 12 to Week 102) |
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Full Analysis Set (FAS) included all enrolled participants who received at least 1 dose of ravagalimab and was used for all baseline and efficacy analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ravagalimab 600 mg/ 300 mg | Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC EOW from Week 12 through Week 102. |
| 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 | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Endoscopic Improvement During Induction Period | Endoscopic Improvement is defined as Mayo endoscopic subscore of 0 or 1. Mayo endoscopic score is classified as 0=Normal or inactive disease; 1=Mild disease (erythema, decreased vascular pattern); 2=Moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3=Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer. | FAS included all enrolled participants who received at least 1 dose of ravagalimab. Data was reported only for the Induction Period. | Posted | Number | percentage of participants | At Week 8 |
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|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Remission Per Adapted Mayo Score During Induction Period | Clinical remission per Adapted Mayo score is defined as stool frequency subscore (SFS) <=1, and not greater than baseline, rectal bleeding subscore (RBS) = 0, and endoscopic subscore <=1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore confirmed by central reader, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer. | FAS included all enrolled participants who received at least 1 dose of ravagalimab and was used for all baseline and efficacy analyses. Data was reported only for the Induction Period. | Posted | Number | percentage of participants | At Week 8 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Response Per Adapted Mayo Score During Induction Period | Clinical response per Adapted Mayo score is defined as the decrease from Baseline >= 2 points and >= 30%, PLUS a decrease in RBS >=1 or an absolute RBS <=1. The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal), Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed), Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer. | FAS included all enrolled participants who received at least 1 dose of ravagalimab. Data was reported only for the Induction Period. | Posted | Number | percentage of participants | At Week 8 |
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| Secondary | Percentage of Participants With Clinical Response Per Partial Adapted Mayo Score | Clinical response per Partial Adapted Mayo score is defined as decrease from baseline >=1 points and >=30%, PLUS a decrease in RBS >= 1 or an absolute RBS <=1. The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: SFS, scored from 0 (normal number of stools) to 3 (5 or more stools more than normal); RBS, scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 with higher scores representing more severe disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to a nearest whole integer. | FAS included all enrolled participants who received at least 1 dose of ravagalimab. Data was reported only for the Induction Period. | Posted | Number | percentage of participants | Up to Week 8 |
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| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Clinical Remission Per Full Mayo Score During Induction Period in Participants With a Full Mayo Score of 6 to 12 at Baseline | Clinical Remission per full Mayo score is defined as Full Mayo score <=2 with no subscore > 1. The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy [confirmed by a central reader], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Endoscopies were assessed by a central reader. Negative changes indicate improvement. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer. | FAS included all enrolled participants who received at least 1 dose of ravagalimab. Overall number analysed is the number of participants available for analysis. Data was reported only for the Induction Period. | Posted | Number | percentage of participants | At Week 8 |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Endoscopic Remission During Induction Period | Endoscopic remission is defined as Mayo endoscopic subscore = 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration). Higher score indicates worsening of the disease. The number of responders is calculated based on the total number of participants and estimated response rate, rounding to the nearest whole integer. | FAS included all enrolled participants who received at least 1 dose of ravagalimab. Data was reported only for the Induction Period. | Posted | Number | percentage of participants | At Week 8 |
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From first dose of study drug up to safety follow up visit (up to approximately 116 weeks)
Safety Analysis Set included all participants who received at least 1 dose of study drug.
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 | Induction Period: Ravagalimab 600 mg/300 mg | Participants received ravagalimab 600 mg IV at Week 0 followed by ravagalimab 300 mg SC at Weeks 2, 4, 6, 8, and 10 in a 12-week Induction Period. | 0 | 42 | 2 | 42 | 15 | 42 |
| EG001 | Maintenance Period: Ravagalimab 300 mg | Participants who achieved clinical response per partial adapted Mayo score at Week 12 of the Induction Period entered the Maintenance Period to receive ravagalimab 300 mg SC EOW from Week 12 through Week 102. | 0 | 29 | 2 | 29 | 19 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| LARGE INTESTINE INFECTION | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| PERIRECTAL ABSCESS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 24.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 24.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| TOOTH ABSCESS | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| IRON DEFICIENCY | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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| SKIN LESION | Skin and subcutaneous tissue disorders | MedDRA 24.1 | Systematic Assessment |
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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 | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 10, 2021 | Jan 9, 2023 | SAP_001.pdf |
Not provided
| 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
| Unknown or Not Reported |
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| Participants |
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