A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD) (anaSTILLs)

• ClinicalTrials.gov Identifier: NCT03265132
• Recruitment Status: Terminated
• First Posted: August 29, 2017
• Results First Posted: April 28, 2020
• Last Update Posted: June 30, 2021
• Sponsor: Swedish Orphan Biovitrum
• Information provided by (Responsible Party): Swedish Orphan Biovitrum

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Conditions: Still's Disease, Adult-Onset; Still's Disease, Juvenile-Onset
• Interventions: Biological: anakinra; Drug: Placebo
• Enrollment: 13

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Anakinra	Placebo
Arm/Group Description	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Period Title: Overall Study
Started	6	6 [1]
Completed	6	0
Not Completed	0	6
Reason Not Completed
Adverse Event	0	1
Lack of Efficacy	0	2
Progressive disease	0	2
Withdrawal by Subject	0	1
[1] One patient failed disease specific inclusion criteria and was excluded from efficacy analysis

Baseline Characteristics

Arm/Group Title		Placebo	Anakinra	Total
Arm/Group Description		Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Total of all reporting groups
Overall Number of Baseline Participants		5	6	11
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	5 participants	6 participants	11 participants
		14.4 (13.2)	12.3 (19.3)	13.3 (16.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	5 participants	6 participants	11 participants
	Female	3 60.0%	2 33.3%	5 45.5%
	Male	2 40.0%	4 66.7%	6 54.5%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	5 participants	6 participants	11 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	1 20.0%	1 16.7%	2 18.2%
	White	4 80.0%	5 83.3%	9 81.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	5 participants	6 participants	11 participants
		5	6	11
Still's disease symptom duration; Mean (Standard Deviation); Unit of measure: Days
	Number Analyzed	5 participants	6 participants	11 participants
		32.4 (18.7)	109.0 (78.0)	74.2 (69.1)

Outcome Measures

1. Primary Outcome

Title	Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.
Description	ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by >30% from baseline. (ACR: American College of Rheumatology); Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm).; Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm).; Number of joints with active arthritis.; Number of joints with limitation of motion.; Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ).; C-Reactive Protein (CRP) (mg/L).
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	6 100.0%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.0022
	Comments	[Not Specified]
	Method	Fisher Exact
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.42 to 1.00
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.
Description	ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	5 83.3%	3 60.0%

3. Secondary Outcome

Title	Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1.
Description	ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	5 83.3%	2 40.0%

4. Secondary Outcome

Title	Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1.
Description	ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	5 83.3%	0 0.0%

5. Secondary Outcome

Title	Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1.
Description	ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	4 66.7%	0 0.0%

6. Secondary Outcome

Title	Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2.
Description	ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	6 100.0%	0 0.0%

7. Secondary Outcome

Title	Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2.
Description	ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	6 100.0%	0 0.0%

8. Secondary Outcome

Title	Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2.
Description	ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by >30% from baseline.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	5 83.3%	0 0.0%

9. Secondary Outcome

Title	Proportion of Responders in Physician Global Assessment of Disease Activity.
Description	Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	4 66.7%	0 0.0%

10. Secondary Outcome

Title	Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being.
Description	Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	4
Measure Type: Count of Participants; Unit of Measure: Participants
	4 66.7%	0 0.0%

11. Secondary Outcome

Title	Proportion of Responders in Number of Joints With Active Arthritis.
Description	Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	3 50.0%	2 40.0%

12. Secondary Outcome

Title	Proportion of Responders in Number of Joints With Limitation of Motion.
Description	Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	4 66.7%	2 40.0%

13. Secondary Outcome

Title	Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ).
Description	Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	4 66.7%	0 0.0%

14. Secondary Outcome

Title	Proportion of Responders in CRP (mg/L).
Description	Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	5 83.3%	0 0.0%

15. Secondary Outcome

Title	Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2.
Description	Proportion of patients with absence of fever during the 7 days preceding Week 2.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	6 100.0%	0 0.0%

16. Secondary Outcome

Title	Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1.
Description	Absence of fever during the 24 hours preceding week 1.
Time Frame	Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	6 100.0%	4 80.0%

17. Secondary Outcome

Title	Change From Baseline in Physician Global Assessment of Disease Activity at Week 1.
Description	Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.
Time Frame	Day 1 and Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Mean (Standard Deviation); Unit of Measure: mm
	-46.3 (32.6)	-30.0 (18.5)

18. Secondary Outcome

Title	Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1.
Description	Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.
Time Frame	Day 1 and Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	4
Mean (Standard Deviation); Unit of Measure: mm
	-53.7 (27.7)	-25.0 (31.7)

19. Secondary Outcome

Title	Change From Baseline in CRP.
Description	Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.
Time Frame	Day 1 and Week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Mean (Standard Deviation); Unit of Measure: mg/L
	-109.6 (63.4)	-22.7 (47.1)

20. Secondary Outcome

Title	Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response.
Description	Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	6 100.0%	0 0.0%

21. Secondary Outcome

Title	Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response in Relation to Glucocorticoid Tapering.
Description	Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.
Time Frame	Week 2, Week 4, Week 8 and Week 12

Outcome Measure Data

Analysis Population Description

No patients were treated with any systemic glucocorticoids at randomization

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

22. Secondary Outcome

Title	Proportion of Patients With Absence of Rash.
Description	Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	4
Measure Type: Count of Participants; Unit of Measure: Participants
	5 83.3%	2 50.0%

23. Secondary Outcome

Title	Change From Baseline in CRP.
Description	Change from baseline in CRP. Results at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Mean (Standard Deviation); Unit of Measure: mg/L
	-126.670 (66.697)	-33.904 (64.393)

24. Secondary Outcome

Title	Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here.
Description	Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	3
Mean (Standard Deviation); Unit of Measure: g/dL
	1.57 (0.86)	-0.80 (1.01)

25. Secondary Outcome

Title	Change From Baseline in Platelet Count.
Description	Change from baseline in platelet count. Results at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	3
Mean (Standard Deviation); Unit of Measure: 10^9/L
	-148.2 (52.3)	-26.3 (139.6)

26. Secondary Outcome

Title	Change From Baseline in Ferritin.
Description	Change from baseline in ferritin. Results at Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	5	3
Mean (Standard Deviation); Unit of Measure: ug/L
	-390.364 (387.521)	-49.383 (51.776)

27. Secondary Outcome

Title	Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain.
Description	Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

Patients with baseline and week 2 data analyzed.

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	4
Mean (Standard Deviation); Unit of Measure: score on a scale
	-55.6 (27.7)	-33.5 (28.5)

28. Secondary Outcome

Title	Time to Study Drug Discontinuation for Any Reason.
Description	Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.
Time Frame	From Day 1 to Week12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	5 100.0%

29. Secondary Outcome

Title	Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease.
Description	Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.
Time Frame	From Day 1 to Week12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	4 80.0%

30. Secondary Outcome

Title	Proportion of Patients Who Have Initiated Tapering of Glucocorticoids.
Description	Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Time Frame	From Week 2 to Week12

Outcome Measure Data

Analysis Population Description

No patients were treated with any systemic glucocorticoids at randomization

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

31. Secondary Outcome

Title	Proportion of Patients That Have Decreased the Glucocorticoid Dose With at Least 50% From Baseline.
Description	Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Time Frame	From Week 2 to Week12

Outcome Measure Data

Analysis Population Description

No patients were treated with any systemic glucocorticoids at randomization

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

32. Secondary Outcome

Title	Percentage Decrease of the Glucocorticoid Dose From Baseline.
Description	Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
Time Frame	From Day 1 to Week12

Outcome Measure Data

Analysis Population Description

No patients were treated with any systemic glucocorticoids at randomization

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	0	0

No data displayed because Outcome Measure has zero total analyzed.

33. Secondary Outcome

Title	Proportion of Patients With at Least One Adverse Event.
Description	All adverse events collected from start of study treatment up to 28 days after stopping study treatment.
Time Frame	From Day 1 to Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	6
Measure Type: Count of Participants; Unit of Measure: Participants
	6 100.0%	4 66.7%

34. Secondary Outcome

Title	Proportion of Patients With at Least One Serious Adverse Event Including Death.
Description	Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.
Time Frame	From Informed consent to Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	6
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	1 16.7%

35. Secondary Outcome

Title	Proportion of Patients With Macrophage Activation Syndrome (MAS).
Description	Proportion of patients with Macrophage Activation Syndrome (MAS).
Time Frame	From Day 1 to Week 16

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	6
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

36. Secondary Outcome

Title	Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra.
Description	Proportion of patients with antidrug antibodies (ADA) against anakinra.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	6
Measure Type: Count of Participants; Unit of Measure: Participants
	6 100.0%	1 16.7%

37. Secondary Outcome

Title	Proportion of Patients With Neutralizing Antibodies.
Description	Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	6
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	0 0.0%

38. Secondary Outcome

Title	Anakinra Serum Pre-dose Concentrations.
Description	Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

No data available for the placebo group as they did not receive anakinra.

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	4	0
Mean (Standard Deviation); Unit of Measure: ng/mL
	157 (134)

39. Secondary Outcome

Title	Anakinra Serum Pharmacokinetic Parameters: Cmax,
Description	PK parameters only available for 2 patients.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

PK parameters only available for 2 anakinra treated patients.

Arm/Group Title	Placebo	Anakinra
Arm/Group Description:	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection
Overall Number of Participants Analyzed	0	2
Mean (Standard Deviation); Unit of Measure: ng/mL
		1990.0 (1315.2)

40. Secondary Outcome

Title	Anakinra Serum Pharmacokinetic Parameters, Tmax and T½
Description	PK parameters only available for 2 patients
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

PK parameters only available for 2 patients

Arm/Group Title	Placebo	Anakinra
Arm/Group Description:	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection
Overall Number of Participants Analyzed	0	2
Mean (Standard Deviation); Unit of Measure: hours
Tmax		3.06 (1.33)
T½		5.23 (1.01)

41. Secondary Outcome

Title	Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h
Description	PK parameters only available for 2 patients
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

PK parameters only available for 2 anakinra treated patients

Arm/Group Title	Placebo	Anakinra
Arm/Group Description:	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection
Overall Number of Participants Analyzed	0	2
Mean (Standard Deviation); Unit of Measure: h*ng/mL
		18483.3 (15708.4)

42. Secondary Outcome

Title	Anakinra Serum Pharmacokinetic Parameter: CL/F
Description	Pharmacokinetic parameters only available for 2 patients
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

Pharmacokinetic parameters only available for 2 anakinra treated patients

Arm/Group Title	Placebo	Anakinra
Arm/Group Description:	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection
Overall Number of Participants Analyzed	0	2
Mean (Standard Deviation); Unit of Measure: mL/h*kg
		170.80 (45.69)

43. Secondary Outcome

Title	Anakinra Serum Pharmacokinetic Parameter: Vd/F
Description	PK parameters only available for 2 patients
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

PK parameters only available for 2 anakinra treated patients

Arm/Group Title	Placebo	Anakinra
Arm/Group Description:	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection
Overall Number of Participants Analyzed	0	2
Mean (Standard Deviation); Unit of Measure: mL/kg
		1254.52 (95.57)

44. Secondary Outcome

Title	Change From Baseline in JADAS27.
Description	Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) -10)/10. Before calculation, CRP values <10 mg/l are converted to 10 and CRP values >110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57. Only results from Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	4
Mean (Standard Deviation); Unit of Measure: score on a scale
	-21.42 (3.93)	-15.81 (4.83)

45. Secondary Outcome

Title	Number of Days Off School or Work Due to Still's Disease.
Description	Number of days off school or work due to Still's disease week 1-2.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	4
Mean (Standard Deviation); Unit of Measure: Days
	0.7 (1.6)	1.3 (2.5)

46. Secondary Outcome

Title	Proportion of Patients With Inactive Disease.
Description	Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.
Time Frame	Week 12

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	5
Measure Type: Count of Participants; Unit of Measure: Participants
	3 50.0%	0 0.0%

47. Secondary Outcome

Title	Change From Baseline in IL-6.
Description	Only results from Week 2 reported here.
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	3
Mean (Standard Deviation); Unit of Measure: ng/L
	-30.048 (23.262)	-24.818 (25.940)

48. Secondary Outcome

Title	Change From Baseline in IL-18.
Description	Only results from Week 2 reported here
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	5	3
Mean (Standard Deviation); Unit of Measure: ng/L
	-7968.0 (7564.4)	-20701.7 (32766.4)

49. Secondary Outcome

Title	Change From Baseline in Serum Calprotectin.
Description	Change from baseline in serum calprotectin. Only results from Week 2 reported here
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	6	3
Mean (Standard Deviation); Unit of Measure: mg/L
	-100.038 (113.349)	-26.021 (23.819)

50. Secondary Outcome

Title	Change From Baseline in Neopterin.
Description	Only results from Week 2 reported here
Time Frame	Week 2

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Anakinra	Placebo
Arm/Group Description:	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection	Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
Overall Number of Participants Analyzed	5	3
Mean (Standard Deviation); Unit of Measure: nmol/L
	-3.08 (5.69)	-8.00 (10.82)

Adverse Events

Time Frame	From the start of study treatment up to 28 days after stopping study treatment.
Adverse Event Reporting Description	The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.
Arm/Group Title	Anakinra		Placebo
Arm/Group Description	2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day) anakinra: sub cutaneous injection		Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day Placebo: sub cutaneous injection
All-Cause Mortality
	Anakinra		Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/6 (0.00%)		0/6 (0.00%)
Serious Adverse Events
	Anakinra		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/6 (0.00%)		1/6 (16.67%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma stage III † 1	0/6 (0.00%)	0	1/6 (16.67%)	1
1 Term from vocabulary, MedDRA (Unspecified); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Anakinra		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/6 (100.00%)		4/6 (66.67%)
Gastrointestinal disorders
Vomiting † 1	2/6 (33.33%)	2	0/6 (0.00%)	0
Diarrhoea † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Nausea † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Retching † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
General disorders
Injection site reaction † 1	2/6 (33.33%)	2	1/6 (16.67%)	1
Injection site erythema † 1	1/6 (16.67%)	1	1/6 (16.67%)	1
Injection site pain † 1	0/6 (0.00%)	0	1/6 (16.67%)	1
Injection site rash † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Malaise † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Infections and infestations
Upper respiratory infection † 1	3/6 (50.00%)	3	0/6 (0.00%)	0
Ear infection † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Urinary tract infection † 1	0/6 (0.00%)	0	1/6 (16.67%)	1
Viral upper respiratory tract infection † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Injury, poisoning and procedural complications
Joint injury † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Thermal burn † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Investigations
Vitamin D decrease † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Musculoskeletal and connective tissue disorders
Musculoskeletal pain † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Nervous system disorders
Dizziness † 1	1/6 (16.67%)	1	1/6 (16.67%)	1
Headache † 1	0/6 (0.00%)	0	1/6 (16.67%)	1
Neuralgia † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Psychiatric disorders
Anxiety † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Depression † 1	0/6 (0.00%)	0	1/6 (16.67%)	1
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea † 1	2/6 (33.33%)	2	0/6 (0.00%)	0
Cough † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Nasal congestion † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Skin and subcutaneous tissue disorders
Alopecia † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Night sweats † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
Urticaria † 1	1/6 (16.67%)	1	0/6 (0.00%)	0
1 Term from vocabulary, MedDRA (Unspecified); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Kineret Clinical Program Leader
• Organization: Swedish Orphan Biovitrum
• Phone: +46(8)6972000
• EMail: info@sobi.com

• Responsible Party: Swedish Orphan Biovitrum
• ClinicalTrials.gov Identifier: NCT03265132
• Other Study ID Numbers: Sobi.ANAKIN-301
• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Results First Submitted: February 12, 2020
• Results First Posted: April 28, 2020
• Last Update Posted: June 30, 2021