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

This study is currently recruiting participants.
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01329380
First received: March 17, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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

Condition
Ankylosing Spondylitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Cases Investigation in Patients With Ankylosing Spondylitis)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: at week 24 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
  • Bath ankylosing spondylitis Disease Activity Index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effectiveness evaluation by the investigator [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The level of improvement (markedly improved, improved, not improved, or not assessable) will be rated by comparing clinical condition at week 24 of treatment


Estimated Enrollment: 100
Study Start Date: November 2010
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
those with an exposure

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All patients who receive Humira for the treatment of Ankylosing Spondylitis

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329380

Contacts
Contact: AbbVie Japan PMOS Desk +81-3-4577-1125 AbbVie_JPN_info_clingov@abbvie.com
Contact: Tadamichi Kubo tadamichi.kubo@abbvie.com

  Show 269 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Aki Kuroki, MD AbbVie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01329380     History of Changes
Other Study ID Numbers: P12-764
Study First Received: March 17, 2011
Last Updated: April 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on April 15, 2014