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Special Investigation in Patients With Ulcerative Colitis

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ClinicalTrials.gov Identifier: NCT01947816
Recruitment Status : Active, not recruiting
First Posted : September 23, 2013
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

This investigation will be conducted to obtain the following information regarding the use of Humira 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Ulcerative Colitis.

  1. Unknown adverse reactions (in particular, clinically significant)
  2. Incidence and conditions of occurrence of adverse reactions in clinical practice
  3. Factors likely to affect the safety and effectiveness

Condition or disease
Ulcerative Colitis

Study Design

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation in Patients With Ulcerative Colitis
Study Start Date : August 9, 2013
Estimated Primary Completion Date : February 15, 2018
Estimated Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Humira
Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 160 mg and 2nd dosage of 80 mg in two weeks after the initial administration


Outcome Measures

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Up to Week 52 ]
    Number of patients with adverse events with evaluation beginning upon administration of Humira


Secondary Outcome Measures :
  1. Full Mayo score [ Time Frame: Up to week 52 ]
  2. Partial Mayo score [ Time Frame: Up to week 52 ]
  3. C-reactive Protein [ Time Frame: Up to week 52 ]
  4. Mayo endoscopic sub-score [ Time Frame: Up to week 52 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 99 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients for the first time receiving Humira for the treatment of Ulcerative Colitis
Criteria

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
Contacts and Locations

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): NCT01947816


  Show 406 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Osamu Mikami, MD AbbVie GK
More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01947816     History of Changes
Other Study ID Numbers: P14-190
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017

Keywords provided by AbbVie:
Ulcerative Colitis

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases