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

NCT01412021 | Completed Results

• 1 other identifier: P12-769
• Study Type: observational
• Target: 375
• Locations: 0 countries
• Sites: N/A

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

Conditions

Arthritis, Juvenile Rheumatoid

Keywords

Arthritis, Juvenile Rheumatoid

Outcome Measures

Primary Outcomes (31)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change From Baseline in Serum MMP3 Level at Week 4

  Baseline, Week 4

• Change From Baseline in Serum MMP3 Level at Week 8

  Baseline, Week 8

• Change From Baseline in Serum MMP3 Level at Week 12

  Baseline, Week 12

• Change From Baseline in Serum MMP3 Level at Week 16

  Baseline, Week 16

• Change From Baseline in Serum MMP3 Level at Week 24

  Baseline, Week 24

• 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

• 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

• 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

• 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

• 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

• Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24

  Baseline, Week 24

• Change From Baseline in Height at Week 4

  Baseline, Week 4

• Change From Baseline in Height at Week 8

  Baseline, Week 8

• Change From Baseline in Height at Week 12

  Baseline, Week 12

• Change From Baseline in Height at Week 16

  Baseline, Week 16

• Change From Baseline in Height at Week 24

  Baseline, Week 24

• Change From Baseline in Weight at Week 4

  Baseline, Week 4

• Change From Baseline in Weight at Week 8

  Baseline, Week 8

• Change From Baseline in Weight at Week 12

  Baseline, Week 12

• Change From Baseline in Weight at Week 16

  Baseline, Week 16

• Change From Baseline in Weight at Week 24

  Baseline, Week 24

Other Outcomes (1)

• Number of Participants With Adverse Drug Reactions (ADRs)

  up to Week 24

Study Arms (1)

Humira

Participants with juvenile idiopathic arthritis who received Humira (adalimumab).

Eligibility Criteria

• Age: Up to 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Related Links

• Package Insert Information

MeSH Terms

Conditions

Arthritis, Juvenile

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: July 1, 2011
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: August 8, 2019
• Results First Posted: August 8, 2019

Record last verified: 2019-01