Special Investigation in Patients With Ulcerative Colitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01947816
First received: September 18, 2013
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

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
Ulcerative Colitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation in Patients With Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: Up to Week 52 ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events with evaluation beginning upon administration of Humira


Secondary Outcome Measures:
  • Full Mayo score [ Time Frame: Up to week 52 ] [ Designated as safety issue: No ]
  • Partial Mayo score [ Time Frame: Up to week 52 ] [ Designated as safety issue: No ]
  • C-reactive Protein [ Time Frame: Up to week 52 ] [ Designated as safety issue: No ]
  • Mayo endoscopic sub-score [ Time Frame: Up to week 52 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1500
Study Start Date: August 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947816

Contacts
Contact: AbbVie Japan PMOS Desk +81-3-4577-1125 AbbVie_JPN_info_clingov@abbvie.com
Contact: Tadamichi Kubo tadamichi.kubo@abbvie.com

  Show 361 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Sadanori Abe, MD AbbVie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01947816     History of Changes
Other Study ID Numbers: P14-190
Study First Received: September 18, 2013
Last Updated: July 31, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

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

ClinicalTrials.gov processed this record on September 22, 2014