Special Investigation in Patients With Ulcerative Colitis

NCT01947816 | Completed Results

• 1 other identifier: P14-190
• Study Type: observational
• Target: 1,621
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

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

Conditions

Ulcerative Colitis

Keywords

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

  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

  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

  Weeks 4, 8, 16, 24, 52, when discontinued (up to Week 52), at final assessment (up to Week 52)

Study Arms (1)

Humira

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.

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients for the first time receiving Humira for the treatment of Ulcerative Colitis

You may qualify if:

• Patients receiving Humira for the first time for the treatment of Ulcerative Colitis

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Related Info

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: September 23, 2013
• Study Start: August 9, 2013
• Primary Completion: February 15, 2018
• Study Completion: February 15, 2018
• Last Updated: May 13, 2019
• Results First Posted: May 13, 2019

Record last verified: 2018-11