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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01960790
First received: July 16, 2013
Last updated: August 3, 2016
Last verified: August 2016
  Purpose

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

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

Condition
Behcet's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)

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 156 ] [ Designated as safety issue: Yes ]
    Number of patients with adverse events with evaluation beginning upon administration of Adalimumab


Secondary Outcome Measures:
  • Number of patients with overall evaluation of gastrointestinal symptoms [ Time Frame: Up to Week 156 ] [ Designated as safety issue: No ]
    Evaluation of symptoms including Abdominal pain, Diarrhea, Abdominal fullness, Abdominal tenderness and bleeding

  • Number of patients with evaluation of symptoms of Behcet's disease [ Time Frame: Up to Week 156 ] [ Designated as safety issue: No ]
    Evaluation of symptoms including Recurrent aphthous ulceration of oral mucosa, Skin symptoms, Eye symptoms, Pudendal ulcer, Arthritis without deformity or rigidity, Epididymal inflammation, Vascular and Central nervous system adverse events

  • Number of patients with degree of improvement of endoscopic findings [ Time Frame: Up to Week 156 ] [ Designated as safety issue: No ]
  • C-reactive Protein [ Time Frame: Up to Week 156 ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: July 2013
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: April 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

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients who receive Humira® (Adalimumab) for the treatment of Intestinal Behcet's disease
Criteria

Inclusion Criteria:

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

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: NCT01960790

  Show 453 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Osamu Mikami, MD AbbVie GK
  More Information

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01960790     History of Changes
Other Study ID Numbers: P14-152 
Study First Received: July 16, 2013
Last Updated: August 3, 2016
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Humira®
Behcet's Disease
Adalimumab

Additional relevant MeSH terms:
Behcet Syndrome
Mouth Diseases
Stomatognathic Diseases
Uveal Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Hereditary Autoinflammatory Diseases
Genetic Diseases, Inborn
Skin Diseases, Genetic
Skin Diseases
Skin Diseases, Vascular
Uveitis, Anterior
Panuveitis
Uveitis
Vasculitis

ClinicalTrials.gov processed this record on September 26, 2016