Special Investigation in Patients With Ulcerative Colitis

Study Overview
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Brief Summary
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This investigation will be conducted to obtain the following information regarding the use of Humira 40 mg Syringe 0.8 mL for Subcutaneous Injection in patients with Ulcerative Colitis. Unknown adverse reactions (in particular, clinically significant) Incidence and conditions of occurrence of adverse reactions in clinical practice Factors likely to affect the safety and effectiveness

Official Title
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HUMIRA® 40 mg Syringe 0.8 mL for Subcutaneous Injection Protocol for Special Investigation on Long-Term Administration Ulcerative Colitis

Conditions
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Ulcerative Colitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients receiving Humira for the first time for the treatment of Ulcerative Colitis Exclusion Criteria: Contraindications according to the Package Insert include patients who have any of the following: serious infections tuberculosis a history of hypersensitivity to any ingredient of Humira demyelinating disease or a history of demyelinating disease congestive cardiac failure

Ages Eligible for Study
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Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Humira<br>Humira 40 mg (marketed product) eow for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration, for up to 52 weeks. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Drug Reactions and Serious Adverse Drug Reactions | Adverse drug reactions are defined as adverse events for which the causal relation with Humira cannot be ruled out. Serious adverse drug reactions are adverse drug reaction(s) which have been assessed to be serious based on company criteria. | Up to Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in CRP Levels Over Time |  | Weeks 4, 8, 24, 52 of study drug administration, and at study drug discontinuation (up to Week 52) | 
| Change From Baseline in Mayo Score Over Time | The Mayo score 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, and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Mayo score indicates improvement. | Weeks 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52) | 
| Mayo Endoscopic Sub-Score Over Time | The endoscopist evaluated each observed segment of the colon (rectum, sigmoid, descending colon, transverse colon, ascending colon/cecum) by using the classification 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 24, 52, at study drug discontinuation (up to Week 52), and at final assessment (up to Week 52) | 
| Change From Baseline in Partial Mayo Score Over Time | The Partial Mayo score (Mayo score without endoscopy) ranges from 0 (normal or inactive disease) to 9 (severe disease) and is calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]), each of which ranges from 0 (normal) to 3 (severe disease). A negative change in Partial Mayo score indicates improvement. | Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis