Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)

NCT01960790 | Completed Results

• 1 other identifier: P14-152
• Study Type: observational
• Target: 473
• Locations: 0 countries
• Sites: N/A

Brief Summary

This investigation was conducted to obtain the following information regarding the use of Adalimumab (Humira®) 40mg Syringe 0.8mL for Subcutaneous Injection in patients with Intestinal Behcet's Disease.

1. 1.Incidence and conditions of occurrence of adverse reactions in clinical practice
2. 2.Factors likely to affect the safety and effectiveness

Conditions

Behcet's Disease

Keywords

Humira®; Behcet's Disease; Adalimumab

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Drug Reactions

  The number of participants with adverse drug reactions with evaluation beginning upon administration of Humira® is assessed.

  Up to Week 156

Secondary Outcomes (6)

• Global Assessment of Gastrointestinal Symptoms

  Up to Week 156

• Global Assessment of Gastrointestinal Symptoms of Behcet's Disease

  Up to Week 156

• Number of Participants With Cardinal Symptoms of Behcet's Disease

  Up to Week 156

• Number of Participants With Accessory Symptoms of Behcet's Disease

  Up to Week 156

• Number of Participants With Degree of Improvement of Endoscopic Findings

  Up to Week 156

Study Arms (1)

Participants who received 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 Criteria

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

Study Population

All participants who received Humira® (Adalimumab) for the treatment of Intestinal Behcet's disease

You may qualify if:

• All patients who received Adalimumab for the treatment of Intestinal Behcet's disease (not sufficiently responsive to existing therapies, e.g. steroids, immunomodulator)

You may not qualify if:

• Contraindications according to the Package Insert include patients who had 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 Publications (1)

• Suzuki Y, Hagiwara T, Kobayashi M, Morita K, Shimamoto T, Hibi T. Long-term safety and effectiveness of adalimumab in 462 patients with intestinal Behcet's disease: results from a large real-world observational study. Intest Res. 2021 Jul;19(3):301-312. doi: 10.5217/ir.2020.00013. Epub 2020 Aug 20.

  PMID: 32814420 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Behcet Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• Osamu Mikami, MD

  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: July 16, 2013
• First Posted: October 11, 2013
• Study Start: May 25, 2013
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: March 22, 2019
• Results First Posted: March 22, 2019

Record last verified: 2018-05