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Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (UC)

Clinical Trial Details

The purpose of this research study is to collect long term safety information on HUMIRA® (adalimumab), a monoclonal antibody approved for the treatment of moderate to severely active ulcerative colitis (UC). Information will also be collected for pateints who are using one of the two immunomodulator medications, azathioprine (AZA), and 6-mercaptopurine (6-MP). 
    
This registry deals with the collection and storage of data only. There are no additional procedures or treatments required and no additional risks associated with participation in this collection of data. For 10 years, health information from your original medical records and data resulting from your participation in this registry study will be collected. This data will be collected during your routine doctor visits. Examples of the information collected are: physical examination results, administration/compliance with your medication, any side effects, other medications used during your participation, and laboratory test results.

Key Eligibility: 

A patient will be eligible for participation in this registry if he/she meets inclusion criteria 1 and 3 or 2 and 3: 
    
   1. An adult patient (18 years of age or older) with moderately to severely active Ulcerative Colitis (UC) as per the physician's assessment who has been prescribed HUMIRA®, without or in combination with an immunomodulator (IMM) (6-MP (6-Mercaptopurine) or AZA (Azathioprine)), according to the local product labeling and meets one of the following criteria: 
    
   ● Is currently taking HUMIRA® therapy, and has received at least 8 weeks of HUMIRA® therapy prior to registry entry and the physician can provide source documentation (if available and/or applicable) of Serious Adverse Events (SAEs), Adverse Events of Interests (AEIs), and dosing information since initiation of therapy; 
    
   OR 
    
   ● Is entering after participation in an Abbott or AbbVie sponsored UC study and has received continuous (no more than 70 consecutive days off drug) HUMIRA® therapy since initiation of therapy. 
    
   2. An adult patient (18 years of age or older) with moderately to severely active UC as per the physician's assessment who has been prescribed IMM (6-MP or AZA) therapy, is currently taking IMM (6-MP or AZA) therapy without a concurrent biologic, has received at least 12 consecutive weeks of IMM therapy prior to registry entry and the physician can provide source documentation (if available and/or applicable) of SAEs, AEIs, and dosing information since initiation of therapy. 
    
   3. Patient is capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie and to comply with the requirements of the Registry protocol.

Exclusion Criteria 

   ● On HUMIRA® therapy if they cannot be treated with HUMIRA® in accordance with the local product label or 
   ● On IMM (6-MP or AZA) therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy. 

Patients should not be enrolled into the registry if they are being treated with any investigational agents and/or approved biologics other than HUMIRA®.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Fatiha Chabouni
(212) 746-5109
fac2005@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1408015372

ClinicalTrials.gov:

NCT01848561

Sponsor:

P11-282

Status

Open to Enrollment

Age Group

Adult

Sponsor