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Trial record 1 of 1 for:    NCT03265132
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A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD) (anaSTILLs)

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ClinicalTrials.gov Identifier: NCT03265132
Recruitment Status : Terminated (Meeting enrolment target (81 pat) will not be feasible within reasonable time.)
First Posted : August 29, 2017
Results First Posted : February 28, 2020
Last Update Posted : April 28, 2020
Sponsor:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Anakinra Placebo
Hide 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
Arm/Group Title Placebo Anakinra Total
Hide 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
Hide 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)
1.Primary Outcome
Title Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.
Hide 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)

  1. 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).
  2. Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm).
  3. Number of joints with active arthritis.
  4. Number of joints with limitation of motion.
  5. Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ).
  6. C-Reactive Protein (CRP) (mg/L).
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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%
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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).
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Proportion of patients with absence of fever during the 7 days preceding Week 2.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Absence of fever during the 24 hours preceding week 1.
Time Frame Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.
Time Frame Day 1 and Week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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 Not Reported
22.Secondary Outcome
Title Proportion of Patients With Absence of Rash.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Change from baseline in CRP. Results at Week 2 reported here.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Change from baseline in platelet count. Results at Week 2 reported here.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Change from baseline in ferritin. Results at Week 2 reported here.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with baseline and week 2 data analyzed.
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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 Not Reported
31.Secondary Outcome
Title Proportion of Patients That Have Decreased the Glucocorticoid Dose With at Least 50% From Baseline.
Hide 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 Not Reported
32.Secondary Outcome
Title Percentage Decrease of the Glucocorticoid Dose From Baseline.
Hide 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 Not Reported
33.Secondary Outcome
Title Proportion of Patients With at Least One Adverse Event.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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).
Hide Description Proportion of patients with Macrophage Activation Syndrome (MAS).
Time Frame From Day 1 to Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Proportion of patients with antidrug antibodies (ADA) against anakinra.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Week 2 reported here.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
No data available for the placebo group as they did not receive anakinra.
Arm/Group Title Anakinra Placebo
Hide 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,
Hide Description PK parameters only available for 2 patients.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters only available for 2 anakinra treated patients.
Arm/Group Title Placebo Anakinra
Hide 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
Hide Description PK parameters only available for 2 patients
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters only available for 2 patients
Arm/Group Title Placebo Anakinra
Hide 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)
5.23  (1.01)
41.Secondary Outcome
Title Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h
Hide Description PK parameters only available for 2 patients
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters only available for 2 anakinra treated patients
Arm/Group Title Placebo Anakinra
Hide 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
Hide Description Pharmacokinetic parameters only available for 2 patients
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic parameters only available for 2 anakinra treated patients
Arm/Group Title Placebo Anakinra
Hide 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
Hide Description PK parameters only available for 2 patients
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
PK parameters only available for 2 anakinra treated patients
Arm/Group Title Placebo Anakinra
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Number of days off school or work due to Still's disease week 1-2.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Only results from Week 2 reported here.
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Only results from Week 2 reported here
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Change from baseline in serum calprotectin. Only results from Week 2 reported here
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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.
Hide Description Only results from Week 2 reported here
Time Frame Week 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Anakinra Placebo
Hide 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)
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
Hide 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%)    
Hide 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
Hide 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
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
Layout table for Results Point of Contact information
Name/Title: Kineret Clinical Program Leader
Organization: Swedish Orphan Biovitrum
Phone: +46(8)6972000
EMail: info@sobi.com
Layout table for additonal information
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: February 28, 2020
Last Update Posted: April 28, 2020