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

Arthritis, Juvenile Rheumatoid Clinical Trial

Official title:

Humira® for Subcutaneous Injection Special Investigation ( All-case Survey ) in Patients With Juvenile Idiopathic Arthritis Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412021
• Other study ID #: P12-769
• Status: Completed
• Start date: July 1, 2011
• Est. completion date: April 2, 2018

Study information

• Verified date: January 2019
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: April 2, 2018
• Est. primary completion date: April 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Juvenile Rheumatoid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Drug Reactions (ADRs)	Adverse drug reactions are defined and totaled as collected adverse events whose causal relation with adalimumab cannot be ruled out. An adverse event refers to any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease associated with the use of a drug, whether or not considered related to the drug.	up to Week 24
Primary	Change From Baseline in DAS28-4/ESR at Week 4	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 4
Primary	Change From Baseline in DAS28-4/ESR at Week 8	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 8
Primary	Change From Baseline in DAS28-4/ESR at Week 12	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 12
Primary	Change From Baseline in DAS28-4/ESR at Week 16	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 16
Primary	Change From Baseline in DAS28-4/ESR at Week 24	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 24
Primary	Change From Baseline in DAS28-4/CRP at Week 4	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 4
Primary	Change From Baseline in DAS28-4/CRP at Week 8	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 8
Primary	Change From Baseline in DAS28-4/CRP at Week 12	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 12
Primary	Change From Baseline in DAS28-4/CRP at Week 16	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 16
Primary	Change From Baseline in DAS28-4/CRP at Week 24	The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.	Baseline, Week 24
Primary	Change From Baseline in Serum MMP3 Level at Week 4		Baseline, Week 4
Primary	Change From Baseline in Serum MMP3 Level at Week 8		Baseline, Week 8
Primary	Change From Baseline in Serum MMP3 Level at Week 12		Baseline, Week 12
Primary	Change From Baseline in Serum MMP3 Level at Week 16		Baseline, Week 16
Primary	Change From Baseline in Serum MMP3 Level at Week 24		Baseline, Week 24
Primary	Change From Baseline in Physician Global Assessment (VAS) at Week 4	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.	Baseline, Week 4
Primary	Change From Baseline in Physician Global Assessment (VAS) at Week 8	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.	Baseline, Week 8
Primary	Change From Baseline in Physician Global Assessment (VAS) at Week 12	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.	Baseline, Week 12
Primary	Change From Baseline in Physician Global Assessment (VAS) at Week 16	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.	Baseline, Week 16
Primary	Change From Baseline in Physician Global Assessment (VAS) at Week 24	A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.	Baseline, Week 24
Primary	Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24		Baseline, Week 24
Primary	Change From Baseline in Height at Week 4		Baseline, Week 4
Primary	Change From Baseline in Height at Week 8		Baseline, Week 8
Primary	Change From Baseline in Height at Week 12		Baseline, Week 12
Primary	Change From Baseline in Height at Week 16		Baseline, Week 16
Primary	Change From Baseline in Height at Week 24		Baseline, Week 24
Primary	Change From Baseline in Weight at Week 4		Baseline, Week 4
Primary	Change From Baseline in Weight at Week 8		Baseline, Week 8
Primary	Change From Baseline in Weight at Week 12		Baseline, Week 12
Primary	Change From Baseline in Weight at Week 16		Baseline, Week 16
Primary	Change From Baseline in Weight at Week 24		Baseline, Week 24

External Links

•   Package Insert Information