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

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ClinicalTrials.gov Identifier: NCT01960790
Recruitment Status : Completed
First Posted : October 11, 2013
Last Update Posted : May 31, 2017
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:

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 or disease
Behcet's Disease

Study Type : Observational
Actual Enrollment : 473 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation in Patients With Intestinal Behcet's Disease (All Case Investigation)
Study Start Date : May 25, 2013
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : May 15, 2017


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



Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: Up to Week 156 ]
    Number of patients with adverse events with evaluation beginning upon administration of Adalimumab


Secondary Outcome Measures :
  1. Number of patients with overall evaluation of gastrointestinal symptoms [ Time Frame: Up to Week 156 ]
    Evaluation of symptoms including Abdominal pain, Diarrhea, Abdominal fullness, Abdominal tenderness and bleeding

  2. Number of patients with evaluation of symptoms of Behcet's disease [ Time Frame: Up to Week 156 ]
    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

  3. Number of patients with degree of improvement of endoscopic findings [ Time Frame: Up to Week 156 ]
  4. C-reactive Protein [ Time Frame: Up to Week 156 ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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): NCT01960790


  Show 456 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Osamu Mikami, MD AbbVie GK

Additional Information:
Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01960790     History of Changes
Other Study ID Numbers: P14-152
First Posted: October 11, 2013    Key Record Dates
Last Update Posted: May 31, 2017
Last Verified: May 2017

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

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