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

This study is currently recruiting participants.

Verified April 2013 by AbbVie

Sponsor:

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT01412021

First received: August 5, 2011

Last updated: April 22, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 5, 2011

Last Updated Date

April 22, 2013

Start Date ^ICMJE

August 2011

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event 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 ]

Change History

Complete list of historical versions of study NCT01412021 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

All patients who receive Humira for the treatment of Juvenile idiopathic arthritis

Condition ^ICMJE

Arthritis, Juvenile Rheumatoid

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Humira

those with an exposure

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

100

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: AbbVie Japan PMOS Desk	+81-3-4588-4621	abvj-pmos@abbvie.com
Contact: Toshiro Maeda, MD		toshiro.maeda@abbvie.com

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01412021

Other Study ID Numbers ^ICMJE

P12-769

Has Data Monitoring Committee

Not Provided

Responsible Party

AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Sponsor ^ICMJE

AbbVie (prior sponsor, Abbott)

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Yo Hoshino

AbbVie GK

Information Provided By

AbbVie

Verification Date

April 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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