A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01848561 |
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Recruitment Status :
Recruiting
First Posted : May 7, 2013
Last Update Posted : December 14, 2018
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Sponsor:
AbbVie
Information provided by (Responsible Party):
AbbVie
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Brief Summary:
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
| Condition or disease |
|---|
| Ulcerative Colitis (UC) |
| Study Type : | Observational |
| Estimated Enrollment : | 8250 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Long-Term Non-Interventional Postmarketing Study to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC) |
| Actual Study Start Date : | April 29, 2013 |
| Estimated Primary Completion Date : | April 6, 2027 |
| Estimated Study Completion Date : | April 6, 2027 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Ulcerative colitis
MedlinePlus related topics:
Ulcerative Colitis
Drug Information available for:
Adalimumab
| Group/Cohort |
|---|
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Immunomodulatory Therapy
Patients who are being prescribed and treated with Immunomodulatory Therapy
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Adalimumab (Humira) Treatment
Patients who are prescribed and treated with Adalimumab
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Primary Outcome Measures :
- Evaluation of long term safety of Adalimumab in patients with moderately to severely active UC [ Time Frame: 10 years observational period ]
Secondary Outcome Measures :
- Evaluation of long term effectiveness of Adalimumab in patients with moderately to severely active UC who have had an inadequate response to conventional therapy [ Time Frame: 10 years observational period ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Adult patients with moderately to severely active Ulcerative Colitis (UC) who have been prescribed HUMIRA according to the local label and adult patients being prescribed and treated with IMM (6-mercaptopurine or azathioprine) with no concurrent biologic use.
Criteria
Inclusion Criteria:
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For enrollment into the HUMIRA treatment group; adult patients with moderately to severely active UC who has been prescribed HUMIRA therapy according to routine clinical practice and meets one of the following:
- Is currently taking HUMIRA therapy and has received at least 8 weeks of therapy; OR
- Is entering after participation in an Abbott or AbbVie sponsored UC study and; has received continuous HUMIRA therapy since initiation of therapy
- For enrollment into the IMM treatment group; adult patients with moderately to severely active UC who has been prescribed IMM therapy, is currently taking IMM therapy, and has received at least 12 consecutive weeks of IMM therapy
- Patients capable of and willing to grant authorization for use/disclosure of data being collected and provided to AbbVie prior to any registry-related data being collected, and to comply with the requirements of the Registry protocol
Exclusion Criteria:
- Patients on IMM therapy without a concurrent biologic if they cannot continue to be treated with IMM therapy or
- Patients who are being treated with any investigational agents and/or approved biologics other than Humira
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848561
Contacts
| Contact: ABBVIE CALL CENTER | 847.283.8955 | abbvieclinicaltrials@abbvie.com |
Show 460 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
| Study Director: | AbbVie Inc. | AbbVie |
Additional Information:
| Responsible Party: | AbbVie |
| ClinicalTrials.gov Identifier: | NCT01848561 History of Changes |
| Other Study ID Numbers: |
P11-282 |
| First Posted: | May 7, 2013 Key Record Dates |
| Last Update Posted: | December 14, 2018 |
| Last Verified: | December 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | No | |
Keywords provided by AbbVie:
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Ulcerative Colitis Registry Adalimumab Colitis |
Gastroenteritis Inflammatory Bowel Diseases Gastrointestinal Diseases |
Additional relevant MeSH terms:
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Colitis Ulcer Colitis, Ulcerative Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases |
Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases Adalimumab Anti-Inflammatory Agents Antirheumatic Agents |