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

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ClinicalTrials.gov Identifier: NCT01412021
Recruitment Status : Completed
First Posted : August 8, 2011
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:

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 or disease
Arthritis, Juvenile Rheumatoid

Study Type : Observational
Actual Enrollment : 374 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis
Actual Study Start Date : August 1, 2011
Actual Primary Completion Date : April 2, 2018
Actual Study Completion Date : April 2, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
Humira
those with an exposure



Primary Outcome Measures :
  1. Serum Matrix metalloprotease-3 level [ Time Frame: at week 12 ]
  2. Weight [ Time Frame: at week 4 ]
  3. Anti-cyclic citrullinated peptides antibodies [ Time Frame: at baseline ]
  4. Serum Matrix metalloprotease-3 level [ Time Frame: at week 8 ]
  5. Height [ Time Frame: at week 16 ]
  6. Disease Activity Score28 [ Time Frame: at week 12 ]
  7. Weight [ Time Frame: at week 16 ]
  8. Anti-cyclic citrullinated peptides antibodies [ Time Frame: at week 24 ]
  9. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 4 ]
  10. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 24 ]
  11. Height [ Time Frame: at week 24 ]
  12. Disease Activity Score28 [ Time Frame: at week 16 ]
  13. Height [ Time Frame: at week 12 ]
  14. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 16 ]
  15. Number of patients with adverse drug reactions [ Time Frame: at week 24 ]
    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

  16. Disease Activity Score28 [ Time Frame: at week 8 ]
  17. Serum Matrix metalloprotease-3 level [ Time Frame: at week 4 ]
  18. Serum Matrix metalloprotease-3 level [ Time Frame: at week 16 ]
  19. Weight [ Time Frame: at week 8 ]
  20. Weight [ Time Frame: at week 12 ]
  21. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 8 ]
  22. Disease Activity Score28 [ Time Frame: at week 4 ]
  23. Disease Activity Score28 [ Time Frame: at week 24 ]
  24. Serum Matrix metalloprotease-3 level [ Time Frame: at week 24 ]
  25. Height [ Time Frame: at week 4 ]
  26. Height [ Time Frame: at week 8 ]
  27. Weight [ Time Frame: at week 24 ]
  28. Global health by physicians (Visual Analog Scale) [ Time Frame: at week 12 ]


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

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): NCT01412021


  Show 144 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01412021     History of Changes
Other Study ID Numbers: P12-769
First Posted: August 8, 2011    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Arthritis, Juvenile Rheumatoid

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