N/A
Completed N=375
Special Investigation (All Case Survey) in Patients With Juvenile Idiopathic Arthritis
Arthritis, Juvenile Rheumatoid
Source: ClinicalTrials.gov NCT01412021 ↗
Enrolled (actual)
375
Serious AEs
4.8%
Results posted
Aug 2019
Primary outcomePrimary: Change From Baseline in DAS28-4/ESR at Week 4 — -1.01 units on a scale — p=< 0.0001
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in DAS28-4/ESR at Week 4 |
-1.01 | < 0.0001 sig |
| PRIMARY Change From Baseline in DAS28-4/ESR at Week 8 |
-1.39 | < 0.0001 sig |
| PRIMARY Change From Baseline in DAS28-4/ESR at Week 12 |
-1.39 | < 0.0001 sig |
| PRIMARY Change From Baseline in DAS28-4/ESR at Week 16 |
-1.46 | < 0.0001 sig |
| PRIMARY Change From Baseline in DAS28-4/ESR at Week 24 |
-1.64 | < 0.0001 sig |
| PRIMARY Change From Baseline in DAS28-4/CRP at Week 4 |
-0.94 | — |
| PRIMARY Change From Baseline in DAS28-4/CRP at Week 8 |
-1.24 | < 0.0001 sig |
| PRIMARY Change From Baseline in DAS28-4/CRP at Week 12 |
-1.29 | — |
| PRIMARY Change From Baseline in DAS28-4/CRP at Week 16 |
-1.35 | < 0.0001 sig |
| PRIMARY Change From Baseline in DAS28-4/CRP at Week 24 |
-1.57 | < 0.0001 sig |
| PRIMARY Change From Baseline in Serum MMP3 Level at Week 4 |
-72.18 | < 0.0001 sig |
| PRIMARY Change From Baseline in Serum MMP3 Level at Week 8 |
-83.36 | < 0.0001 sig |
| PRIMARY Change From Baseline in Serum MMP3 Level at Week 12 |
-78.05 | < 0.0001 sig |
| PRIMARY Change From Baseline in Serum MMP3 Level at Week 16 |
-86.28 | < 0.0001 sig |
| PRIMARY Change From Baseline in Serum MMP3 Level at Week 24 |
-98.67 | < 0.0001 sig |
| PRIMARY Change From Baseline in Physician Global Assessment (VAS) at Week 4 |
-15.5 | < 0.0001 sig |
| PRIMARY Change From Baseline in Physician Global Assessment (VAS) at Week 8 |
-21.5 | < 0.0001 sig |
| PRIMARY Change From Baseline in Physician Global Assessment (VAS) at Week 12 |
-21.8 | < 0.0001 sig |
| PRIMARY Change From Baseline in Physician Global Assessment (VAS) at Week 16 |
-25.3 | < 0.0001 sig |
| PRIMARY Change From Baseline in Physician Global Assessment (VAS) at Week 24 |
-27.0 | — |
| PRIMARY Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24 |
-45.03 | 0.0132 sig |
| PRIMARY Change From Baseline in Height at Week 4 |
0.24 | < 0.0001 sig |
| PRIMARY Change From Baseline in Height at Week 8 |
0.59 | < 0.0001 sig |
| PRIMARY Change From Baseline in Height at Week 12 |
0.88 | < 0.0001 sig |
| PRIMARY Change From Baseline in Height at Week 16 |
1.25 | < 0.0001 sig |
| PRIMARY Change From Baseline in Height at Week 24 |
1.60 | < 0.0001 sig |
| PRIMARY Change From Baseline in Weight at Week 4 |
0.47 | < 0.0001 sig |
| PRIMARY Change From Baseline in Weight at Week 8 |
0.82 | < 0.0001 sig |
| PRIMARY Change From Baseline in Weight at Week 12 |
1.10 | < 0.0001 sig |
| PRIMARY Change From Baseline in Weight at Week 16 |
1.37 | < 0.0001 sig |
| PRIMARY Change From Baseline in Weight at Week 24 |
1.76 | — |
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
Data sourced from ClinicalTrials.gov (NCT01412021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.