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Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01329380
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie

March 17, 2011
April 5, 2011
January 26, 2018
November 29, 2010
December 31, 2017   (Final data collection date for primary outcome measure)
  • Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 12 ]
  • Number of patients with adverse events [ Time Frame: at week 24 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
  • Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 24 ]
  • Number of patients with adverse events [ Time Frame: at week 24 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira
  • Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 12 ]
  • Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 24 ]
Complete list of historical versions of study NCT01329380 on ClinicalTrials.gov Archive Site
  • Effectiveness evaluation by the investigator [ Time Frame: at week 12 ]
    The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment
  • Effectiveness evaluation by the investigator [ Time Frame: at week 24 ]
    The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment
Same as current
Not Provided
Not Provided
 
Special Investigation in Patients With Ankylosing Spondylitis (All Patients Investigation)
Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)

This study of Humira will be conducted to clarify the following with regard to the treatment of ankylosing spondylitis with this drug:

  • Unknown adverse drug reactions (especially important adverse drug reactions)
  • Incidence and conditions of occurrence of adverse reactions in the clinical setting
  • Factors that may affect the safety and effectiveness of Humira
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
All patients who receive Humira for the treatment of Ankylosing Spondylitis
Ankylosing Spondylitis
Not Provided
Humira
those with an exposure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
401
100
December 31, 2017
December 31, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • All patients with Ankylosing Spondylitis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

Exclusion Criteria:

  • Contraindications according to the Package Insert
  • Patients who have serious infections
  • Patients who have tuberculosis
  • Patients with a history of hypersensitivity to any ingredient of Humira
  • Patients who have demyelinating disease or with a history of demyelinating disease
  • Patients who have congestive cardiac failure
Sexes Eligible for Study: All
16 Years to 99 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01329380
P12-764
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: Undecided
AbbVie
AbbVie
Not Provided
Study Director: AbbVie Inc. AbbVie
AbbVie
January 2018