A Study of Anakinra in Japanese Patients With Still's Disease (SJIA and AOSD)

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: All

Summary

A study to demonstrate efficacy and safety of anakinra in pediatric and adult Japanese patients with Still's disease (Systemic juvenile idiopathic arthritis [SJIA] and Adult-onset Still's disease [AOSD]).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Swedish Orphan Biovitrum
• Collaborator: CMIC Co, Ltd. Japan
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

1. Male and female patients, 8 months of age or older with a body weight ≥ 10 kg

2. Diagnosis of Still's disease within 15 months prior to enrollment.

3. If < 16 years of age at disease onset, the diagnosis is madeaccording to adapted ILAR criteria i.e., CARRA criteria for SJIA. If ≥ 16 years of age at disease onset, the diagnosis is made according to Yamaguchi criteria for AOSD.

4. Active disease confirmed by the following three signs and symptoms. a. Active arthritis in ≥ 1 joint. b. CRP > 30 mg/L. c. At least one fever episode (≥ 38.0 degree Celsius) attributable to the disease within one week before enrollment.

5. The result of tuberculosis test within 8 weeks prior to enrollment is negative.

Exclusion Criteria:

1. Previous or current treatment with anakinra, canakinumab,or any other Interleukin-1 (IL-1) inhibitor.

2. Use of the following therapies prior to enrollment.

1. Narcotic analgesics within 24 hours prior to enrollment.

2. Diaminodiphenyl sulfone or etanercept within 3 weeks prior to enrollment.

3. Intraarticular, intramuscular, or intravenous administration of glucocorticoids, or intravenous immunoglobulin within 4 weeks prior to enrollment.

4. Intravenous immunoglobulins with proven Still's disease modifying effect, leflunomide, infliximab, or adalimumab within 8 weeks prior to enrollment.

5. Thalidomide, cyclosporine, mycophenolate mofetil, 6-mercaptopurine, azathioprine, cyclophosphamide, chlorambucil (not approved inJapan), or any other immunosuppressants within 12 weeks prior to enrollment.

6. Tocilizumab within 4 weeks prior to enrollment or any other immunomodulatory medications within 4 half-lives prior to enrollment.

7. Rituximab within 26 weeks prior to enrollment.

3. Live vaccines within 4 weeks prior to enrollment.

4. Known presence or suspicion of active, chronic, or recurrent bacterial, fungal, or viral infections, including but not limited to tuberculosis, HIV infection, Covid-19 infection, or hepatitis B or C infection at baseline. Patients with acute or chronic HBV.

5. Clinical evidence of liver disease or liver injury as indicated by presence of abnormal liver tests.

6. Presence of severe chronic kidney disease (CKD) grades 4 and 5.

7. Presence of neutropenia (absolute neutrophil count [ANC] < 1.5 x 10^9/L).

8. Presence of thrombocytopenia (platelets count < 100 x 10^9/L).

9. Presence or suspicion of MAS at baseline.

10. A diagnosis of MAS within the last 8 weeks prior to enrollment.