Clinical trial NCT01412021: Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis
Official title: Humira® for Subcutaneous Injection Special Investigation ( All-case Survey ) in Patients With Juvenile Idiopathic Arthritis Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Arthritis, Juvenile Rheumatoid
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 375
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who receive Humira for the treatment of 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


Eligibility 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

Primary outcomes:
measure: Change From Baseline in DAS28-4/ESR at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in DAS28-4/ESR at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in DAS28-4/ESR at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in DAS28-4/ESR at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in DAS28-4/ESR at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in DAS28-4/CRP at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in DAS28-4/CRP at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in DAS28-4/CRP at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in DAS28-4/CRP at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in DAS28-4/CRP at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Serum MMP3 Level at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Serum MMP3 Level at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Serum MMP3 Level at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Serum MMP3 Level at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Serum MMP3 Level at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Physician Global Assessment (VAS) at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Physician Global Assessment (VAS) at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Physician Global Assessment (VAS) at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Physician Global Assessment (VAS) at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Physician Global Assessment (VAS) at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Height at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Height at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Height at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Height at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Height at Week 24
timeFrame: Baseline, Week 24
measure: Change From Baseline in Weight at Week 4
timeFrame: Baseline, Week 4
measure: Change From Baseline in Weight at Week 8
timeFrame: Baseline, Week 8
measure: Change From Baseline in Weight at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Weight at Week 16
timeFrame: Baseline, Week 16
measure: Change From Baseline in Weight at Week 24
timeFrame: Baseline, Week 24
Secondary outcomes:
Other outcomes:
measure: Number of Participants With Adverse Drug Reactions (ADRs)
timeFrame: up to Week 24
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: