Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01412021
First received: August 5, 2011
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints 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
Arthritis, Juvenile Rheumatoid

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Number of patients with adverse drug reactions [ Time Frame: at week 24 ] [ Designated as safety issue: Yes ]
    Occurrence of adverse event (yes or no), nature of adverse drug reactions, date of onset, seriousness, clinical course of adverse drug reactions, outcome, measures, causal relationship between the adverse drug reactions and Humira

  • Disease Activity Score28 [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Disease Activity Score28 [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Disease Activity Score28 [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Disease Activity Score28 [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Disease Activity Score28 [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Serum Matrix metalloprotease-3 level [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Height [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Weight [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Anti-cyclic citrullinated peptides antibodies [ Time Frame: at baseline ] [ Designated as safety issue: No ]
  • Anti-cyclic citrullinated peptides antibodies [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 8 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 16 ] [ Designated as safety issue: No ]
  • Global health by physicians (Visual Analog Scale) [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
those with an exposure

  Eligibility

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 Juvenile idiopathic arthritis

Criteria

Inclusion Criteria:

  • All patients with Juvenile idiopathic arthritis 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: NCT01412021

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

  Show 119 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Yo Hoshino AbbVie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01412021     History of Changes
Other Study ID Numbers: P12-769
Study First Received: August 5, 2011
Last Updated: July 31, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Arthritis, Juvenile Rheumatoid

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on October 23, 2014