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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 July 23, 2014