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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001346-29 | EudraCT Number |
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This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects receiving Adalimumab | Experimental | Subjects receiving Adalimumab up to 288 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | every other week or weekly subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) 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. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks). |
| Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) | The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:
The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1. | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 |
| Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) | The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:
The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical response was defined as a decrease in PMS ≥ 2 points and ≥ 30% from Study M11-290 Baseline. |
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Inclusion Criteria:
- Subject must have successfully enrolled and completed M11-290 study
Exclusion Criteria:
- Subject considered by the investigator, for any reason, to be an unsuitable candidate
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arnold Palmer Hospital /ID# 147295 | Orlando | Florida | 32806 | United States | ||
| MNGI Digestive Health, P. A. /ID# 147294 |
Not provided
| Label | URL |
|---|---|
| This Clinical Study maybe evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses. | View source |
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AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight < 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - < 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 4, 2021 | Sep 29, 2025 |
Not provided
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| Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 |
| Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission | The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). Clinical remission was defined as a PUCAI score < 10. | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 |
| Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) | The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). PUCAI response was defined as a decrease in PUCAI score ≥ 20 points from Study M11-290 Baseline. | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 |
| Minneapolis |
| Minnesota |
| 55413-2195 |
| United States |
| Mayo Clinic - Rochester /ID# 147304 | Rochester | Minnesota | 55905-0001 | United States |
| MultiCare Institute Health System /ID# 169005 | Tacoma | Washington | 98405 | United States |
| Kurume University Hospital /ID# 145710 | Kurume-shi | Fukuoka | 830-0011 | Japan |
| Juntendo University Hospital /ID# 147315 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| National Center for Child Health and Development /ID# 147312 | Setagaya-ku | Tokyo | 157-8535 | Japan |
| Uniwersytecki Szpital Dzieciecy w Krakowie /ID# 147279 | Krakow | Lesser Poland Voivodeship | 30-663 | Poland |
| Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 147310 | Wroclaw | Lower Silesian Voivodeship | 50-369 | Poland |
| Centrum Zdrowia MDM /ID# 147280 | Warsaw | Masovian Voivodeship | 00-189 | Poland |
| Gabinet Lekarski Bartosz Korcz /ID# 147281 | Rzeszów | Podkarpackie Voivodeship | 35-210 | Poland |
| Instytut Centrum Zdrowia Matki Polki /ID# 169017 | Lodz | Łódź Voivodeship | 93-338 | Poland |
| Univerzitna nemocnica Martin /ID# 147283 | Martin | Žilina Region | 036 01 | Slovakia |
| Hospital Universitario Vall d'Hebron /ID# 147288 | Barcelona | 08035 | Spain |
| Disc_Barts Health NHS Trust - The Royal London Hospital /ID# 147290 | London | Greater London | E1 2ES | United Kingdom |
| Duplicate_The Royal Free London NHS Foundation Trust /ID# 147292 | London | Greater London | NW3 2QG | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight < 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - < 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Proportion of Participants with Partial Mayo Score (PMS) Remission at Baseline | The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:
The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. | Count of Participants | Participants |
| |||||||||||||||||
| Proportion of Participants with PMS Response at Study M11-290 Baseline | The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:
The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. | Count of Participants | Participants |
| |||||||||||||||||
| Proportion of Participants Who Achieve PUCAI Remission at Baseline | The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). | Count of Participants | Participants |
| |||||||||||||||||
| Proportion of Participants Who Achieve PUCAI Response at Study M11-290 Baseline | The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). | Count of Participants | Participants |
|
| 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 | Number of Participants With Adverse Events (AEs) | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) 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. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. | Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | From first dose of study drug until 70 days following last dose of study drug (up to 298 weeks). |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Achieve Clinical Remission as Measured by Partial Mayo Score (PMS) | The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:
The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical remission was defined as a PMS ≤ 2 and no individual subscore > 1. | Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 |
| |||||||||||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Achieve Clinical Response as Measured by PMS (From Study M11-290 Baseline) | The Partial Mayo Score (PMS) is a composite score of UC disease activity based on the following 3 subscores:
The overall Partial Mayo score ranges from 0 to 9 with higher scores representing more severe disease. Clinical response was defined as a decrease in PMS ≥ 2 points and ≥ 30% from Study M11-290 Baseline. | Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 |
| |||||||||||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Achieve Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission | The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). Clinical remission was defined as a PUCAI score < 10. | Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 |
| |||||||||||||||||||||||||||||||||||
| Primary | Proportion of Participants Who Achieve PUCAI Response (From Study M11-290 Baseline) | The Pediatric Ulcerative Colitis Activity Index (PUCAI) measures UC disease activity in children and adolescents by evaluating the following 6 areas: abdominal pain, number of stools per day, stool consistency, amount of blood in stools, nocturnal stooling, and activity level. The PUCAI score ranges from 0 to 85 with higher scores representing more severe disease. Recommended cut-off scores to differentiate disease activity are 0-9 (inactive), 10-34 (mild), 35-64 (moderate), and > 65 (severe). PUCAI response was defined as a decrease in PUCAI score ≥ 20 points from Study M11-290 Baseline. | Integrated Full Analysis Set (IFAS) included all enrolled participants who received at least 1 dose of study drug. | Posted | Count of Participants | Participants | Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96,108,120, 144, 168, 192, 216, 240, 264, and 288 |
|
All-cause mortality were reported from enrollment up to 298 weeks, median time on follow up (median time subjects were followed) was 1723.0 days for adalimumab. Treatment-emergent adverse events and serious adverse events were collected from first dose of study drug until 70 days after the last dose of study drug; mean duration on study drug was 1354.2 days for adalimumab.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adalimumab | Participants received adalimumab every other week (EOW) or every week (EW) subcutaneous injection for up to 288 weeks. (Prior to Amendment 4): Participants who enrolled into the study from blinded treatment in Study M11-290 received open-label adalimumab 0.6 mg/kg (maximum dose of 40 mg) EOW. Participants who received open-label adalimumab 0.6 mg/kg (maximum of 40 mg) EW in Study M11-290 maintained the same dose in Study M10-870. (After Amendment 4): Participants with a body weight < 25 kg received open-label adalimumab 20 mg EOW. Participants with a body weight ≥ 25 kg - < 40 kg received open-label adalimumab 40 mg EOW. Participants with a body weight ≥ 40 kg received open-label adalimumab 80 mg EOW. | 0 | 59 | 16 | 59 | 54 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BLOOD LOSS ANAEMIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DYSPEPSIA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| RECTAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CHOLECYSTITIS | Hepatobiliary disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| LATENT TUBERCULOSIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| LYMPH NODE ABSCESS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| FOOT FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
| |
| GROWTH FAILURE | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HAEMATOCOLPOS | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| OVARIAN CYST | Reproductive system and breast disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| CONSTIPATION | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| GASTRITIS | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| VOMITING | Gastrointestinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| FATIGUE | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| PYREXIA | General disorders | MedDRA 27.1 | Systematic Assessment |
| |
| SEASONAL ALLERGY | Immune system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| BRONCHITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| HERPES ZOSTER | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| NASOPHARYNGITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| PHARYNGITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| TONSILLITIS | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
| |
| MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE | Investigations | MedDRA 27.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DEPRESSION | Psychiatric disorders | MedDRA 27.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
| |
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| RASH | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 27.1 | 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 | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 8, 2019 | Sep 29, 2025 | SAP_001.pdf |
| 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
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|
|
|
|
|
|