NCT01412021

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

Completed Results posted Last updated 8 August 2019

What this trial tests

trial in Arthritis, Juvenile Rheumatoid in 375 participants. Completed in 2 April 2018.

Timeline

1 July 2011

Primary endpoint
2 April 2018

2 April 2018

Quick facts

Lead sponsor	AbbVie
Status	Completed
Study type	OBSERVATIONAL
Enrollment	375
Start date	1 July 2011
Primary completion	2 April 2018
Estimated completion	2 April 2018

Conditions studied

• Arthritis, Juvenile Rheumatoid — all drugs for Arthritis, Juvenile Rheumatoid →

Sponsor

AbbVie — full company profile →

Who can join

Under 99, any sex, with Arthritis, Juvenile Rheumatoid. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Humira	-1.01	± 1.08

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

Group	Value	95% CI
Humira	-1.39	± 1.26

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

Group	Value	95% CI
Humira	-1.39	± 1.28

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

Group	Value	95% CI
Humira	-1.46	± 1.40

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

Group	Value	95% CI
Humira	-1.64	± 1.52

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

Group	Value	95% CI
Humira	-0.94	± 1.01

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

Group	Value	95% CI
Humira	-1.24	± 1.14

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

Group	Value	95% CI
Humira	-1.29	± 1.12

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

Group	Value	95% CI
Humira	-1.35	± 1.23

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

Group	Value	95% CI
Humira	-1.57	± 1.36

Change From Baseline in Serum MMP3 Level at Week 4 Primary · Baseline, Week 4

Group	Value	95% CI
Humira	-72.18	± 138.24

Change From Baseline in Serum MMP3 Level at Week 8 Primary · Baseline, Week 8

Group	Value	95% CI
Humira	-83.36	± 159.27

Adverse events — posted to ClinicalTrials.gov

Time frame: up to Week 24. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Humira

Serious: 17/356 (5%)

Deaths: 0/356

Serious adverse events (24 terms)

Reaction	System	Humira
Pharyngitis	Infections and infestations	—
Tonsillitis	Infections and infestations	—
Arthritis	Musculoskeletal and connective tissue disorders	—
Appendicitis	Infections and infestations	—
Bronchitis	Infections and infestations	—
Disseminated tuberculosis	Infections and infestations	—
Pulmonary tuberculosis	Infections and infestations	—
Salpingitis	Infections and infestations	—
Upper respiratory tract infection	Infections and infestations	—
Lymphadenitis	Blood and lymphatic system disorders	—
Hyponatraemia	Metabolism and nutrition disorders	—
Water intoxication	Metabolism and nutrition disorders	—
Epilepsy	Nervous system disorders	—
Febrile convulsion	Nervous system disorders	—
Papillophlebitis	Eye disorders	—
Adenoidal hypertrophy	Respiratory, thoracic and mediastinal disorders	—
Tonsillar hypertrophy	Respiratory, thoracic and mediastinal disorders	—
Stomatitis	Gastrointestinal disorders	—
Gastric mucosal lesion	Gastrointestinal disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Mixed connective tissue disease	Musculoskeletal and connective tissue disorders	—
Osteonecrosis	Musculoskeletal and connective tissue disorders	—
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	—
Juvenile idiopathic arthritis	Musculoskeletal and connective tissue disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Humira
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Pharyngitis, Tonsillitis, Arthritis, Appendicitis, Bronchitis, Disseminated tuberculosis, Pulmonary tuberculosis, Salpingitis.

Data from ClinicalTrials.gov NCT01412021 adverse events section.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Safety and effectiveness of adalimumab in Japanese patients with juvenile idiopathic arthritis: Results from a real-world postmarketing study.
   Takei S, Iwata N, Kobayashi I, Igarashi T, et al · · 2021 · cited 1× · PMID 32340508 · DOI 10.1080/14397595.2020.1761075