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Completed

NCT Number: NCT01412021

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

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

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Key information

Conditions

Arthritis, Juvenile Rheumatoid Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Change From Baseline in DAS28-4/ESR at Week 4

    Time frame: Baseline, 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.

  2. Change From Baseline in DAS28-4/ESR at Week 8

    Time frame: Baseline, 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.

  3. Change From Baseline in DAS28-4/ESR at Week 12

    Time frame: Baseline, 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.

  4. Change From Baseline in DAS28-4/ESR at Week 16

    Time frame: Baseline, 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.

  5. Change From Baseline in DAS28-4/ESR at Week 24

    Time frame: Baseline, 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.

  6. Change From Baseline in DAS28-4/CRP at Week 4

    Time frame: Baseline, 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.

  7. Change From Baseline in DAS28-4/CRP at Week 8

    Time frame: Baseline, 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.

  8. Change From Baseline in DAS28-4/CRP at Week 12

    Time frame: Baseline, 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.

  9. Change From Baseline in DAS28-4/CRP at Week 16

    Time frame: Baseline, 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.

  10. Change From Baseline in DAS28-4/CRP at Week 24

    Time frame: Baseline, 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.

  11. Change From Baseline in Serum MMP3 Level at Week 4

    Time frame: Baseline, Week 4

  12. Change From Baseline in Serum MMP3 Level at Week 8

    Time frame: Baseline, Week 8

  13. Change From Baseline in Serum MMP3 Level at Week 12

    Time frame: Baseline, Week 12

  14. Change From Baseline in Serum MMP3 Level at Week 16

    Time frame: Baseline, Week 16

  15. Change From Baseline in Serum MMP3 Level at Week 24

    Time frame: Baseline, Week 24

  16. Change From Baseline in Physician Global Assessment (VAS) at Week 4

    Time frame: Baseline, 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.

  17. Change From Baseline in Physician Global Assessment (VAS) at Week 8

    Time frame: Baseline, 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.

  18. Change From Baseline in Physician Global Assessment (VAS) at Week 12

    Time frame: Baseline, 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.

  19. Change From Baseline in Physician Global Assessment (VAS) at Week 16

    Time frame: Baseline, 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.

  20. Change From Baseline in Physician Global Assessment (VAS) at Week 24

    Time frame: Baseline, 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.

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

    Time frame: Baseline, Week 24

  22. Change From Baseline in Height at Week 4

    Time frame: Baseline, Week 4

  23. Change From Baseline in Height at Week 8

    Time frame: Baseline, Week 8

  24. Change From Baseline in Height at Week 12

    Time frame: Baseline, Week 12

  25. Change From Baseline in Height at Week 16

    Time frame: Baseline, Week 16

  26. Change From Baseline in Height at Week 24

    Time frame: Baseline, Week 24

  27. Change From Baseline in Weight at Week 4

    Time frame: Baseline, Week 4

  28. Change From Baseline in Weight at Week 8

    Time frame: Baseline, Week 8

  29. Change From Baseline in Weight at Week 12

    Time frame: Baseline, Week 12

  30. Change From Baseline in Weight at Week 16

    Time frame: Baseline, Week 16

  31. Change From Baseline in Weight at Week 24

    Time frame: Baseline, Week 24

Other outcomes

  1. Number of Participants With Adverse Drug Reactions (ADRs)

    Time frame: up to Week 24

    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.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Aug 8, 2011
Registry last updated
Aug 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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