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



Status:Recruiting
Healthy:No
Age Range:Any
Updated:2/24/2019
Start Date:September 26, 2017
End Date:December 31, 2019
Contact:Bent Winding, MD
Email:anaSTILLs@sobi.com
Phone:+46 8 697 2000

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A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of 2 Dose Levels of Subcutaneous Anakinra (Kineret®) in Patients With Still's Disease (SJIA and AOSD)

The aim of this study is to demonstrate the efficacy and to evaluate the safety,
pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's
disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset
Still's disease).

The study consists of a 12-week, randomized, double-blind, placebo controlled period with two
dose levels of anakinra and a 4-week safety follow-up after last dose of investigational
medicinal product (IMP). The primary endpoint will be evaluated at Week 2. Sustained efficacy
and time to early termination will be evaluated during the full study period.

A screening visit is optional and may be done to identify patients that could be suitable for
the study. During the study 6 visits and 2 telephone contacts are scheduled i.e., Day 1
(baseline visit), Day 4Tel, Week 1, Week 2, Week 4, Week 8, Week 12 and Week 16Tel (End of
Study).

Patients will be randomly assigned to study drug, after they meet all of the inclusion
criteria and none of the exclusion criteria. Patients will receive treatment for 12 weeks,
either anakinra or placebo. Patients will be randomized to anakinra in a dose of either 2 or
4 mg/kg/day, with a maximum dose of 100 or 200 mg once daily, respectively. Patients will be
randomized to placebo with corresponding volumes for each of the two anakinra dose levels.

Inclusion Criteria:

1. Signed informed consent.

2. Male and female patients with a body weight ≥ 10 kg.

3. Diagnosis of Still's disease.

4. If currently on glucocorticoid treatment, a stable dose for at least 1 week prior to
randomization.

5. If currently on methotrexate treatment, a stable dose for at least 8 weeks prior to
randomization.

6. Active disease.

7. Female patients of childbearing potential must use an effective method of
contraception during the study (abstinence being a possible option) as well as present
a negative pregnancy test prior to randomization.

8. Negative interferon-gamma release assay or Purified protein derivative ( PPD) test
within 2 months prior to randomization. If not available, a test should be performed
at day of randomization.

Exclusion Criteria:

1. Diagnosis of Still's disease more than 6 months prior to randomization.

2. Previous randomization into this study.

3. Participation in another concurrent clinical interventional study within 30 days of
randomization.

4. Treatment with an investigational drug within 5 half-lives prior to randomization.

5. Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor.

6. Use of the following therapies prior to randomization:

- Narcotic analgesics within 24 hours prior to randomization.

- Tocilizumab, dapsone or mycophenolate mofetil within 3 weeks prior to
randomization.

- Etanercept, leflunomide, thalidomide, or cyclosporine or intraarticular,
intramuscular or intravenous administration of glucocorticoids within 4 weeks
prior to randomization.

- Intravenous immunoglobulin (i.v. Ig) or adalimumab within 8 weeks prior to
randomization.

- Infliximab, 6-mercaptopurine, azathioprine, cyclophosphamide or chlorambucil
within 12 weeks prior to randomization.

- Rituximab within 26 weeks prior to randomization.

7. Live vaccines within 1 month prior to randomization.

8. Known presence or suspicion of active, chronic or recurrent bacterial, fungal or viral
infections, including tuberculosis, HIV infection or hepatitis B or C infection.

9. Clinical evidence of liver disease or liver injury.

10. Presence of severe renal function impairment.

11. Presence of neutropenia.

12. Current signs and symptoms of MAS as judged by the investigator.

13. A diagnosis of MAS within the last 2 months prior to randomization.

14. History of malignancy.

15. Known hypersensitivity to E coli-derived proteins, or any components of Kineret®
(anakinra).

16. Pregnant or lactating women.

17. Foreseeable inability to cooperate with given instructions or study procedures.

18. Presence of any medical or psychological condition or laboratory result that in the
opinion of the investigator can interfere with the patient's ability to comply with
the protocol requirements or makes the patient not appropriate for inclusion to the
study and treatment with IMP.
We found this trial at
37
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Saint Louis, Missouri 63110
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
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700 Childrens Drive
Columbus, Ohio 43205
(616) 722-2000
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Gainesville, Florida 32610
(352) 392-3261
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Miami, Florida 33124
(305) 284-2211
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Minneapolis, Minnesota 55455
(612) 625-5000
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
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Seattle, Washington 98104
(206) 543-2100
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
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Beverly Hills, California 90039
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
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Burlington, Vermont 05405
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Chapel Hill, North Carolina 27599
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Cleveland, Ohio 44109
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
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Eagan, Minnesota 55121
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
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6621 Fannin St
Houston, Texas 77030
(832) 824-1000
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Kansas City, Kansas 66160
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Miami, Florida 33155
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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535 E 70th St
New York, New York 10021
(212) 606-1000
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630 W 168th St
New York, New York
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Richmond, Virginia 23298
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Salt Lake City, Utah 84132
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San Diego, California 92123
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33 Upper Overlook Road
Summit, New Jersey 07901
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Winston-Salem, North Carolina 27157
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