ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab (ß-SPECIFIC 4)
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| ClinicalTrials.gov Identifier: NCT02296424 |
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Recruitment Status :
Completed
First Posted : November 20, 2014
Results First Posted : July 9, 2019
Last Update Posted : July 9, 2019
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Systemic Juvenile Idiopathic Arthritis (SJIA) | Drug: ACZ885 150 mg (Canakinumab) | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 182 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | A two-part open-label study that collected long-term efficacy, safety, and tolerability data from SJIA patients receiving canakinumab treatment who had inactive disease at the last visit in Study CACZ885G2301E1 (Cohort 1), and from SJIA patients who were canakinumab treatment-naïve and had active disease at the time of screening for this study (Cohort 2) |
| Masking: | None (Open Label) |
| Masking Description: | No blinding was required in this open-label study |
| Primary Purpose: | Treatment |
| Official Title: | β-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) |
| Actual Study Start Date : | November 17, 2014 |
| Actual Primary Completion Date : | October 14, 2016 |
| Actual Study Completion Date : | September 25, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Canakinumab Dose Reduction
All patients received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 1 in Part II of the study: Canakinumab was administered at a reduced dose (2 mg/kg every 4 weeks). If the patient continued to maintain inactive disease for 24 additional weeks, canakinumab was administered at 1mg/kg every 4 weeks. If the patient continued to maintain inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
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Drug: ACZ885 150 mg (Canakinumab)
Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.
Other Name: ACZ885 150 mg |
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Experimental: Canakinumab Dose Interval Prolongation
All participants received canakinumab 4mg/kg (300 mg max) every 4 weeks in Part I of the study. Patients eligible for Part II of the study were randomized to one of two treatment arms. This is Treatment Arm 2 in Part II of the study: Canakinumab dose interval was prolonged to a regimen of 4mg/kg every 8 weeks. If the patient continued to be stable with inactive disease for 24 additional weeks, canakinumab dose interval was prolonged to a regimen of 4mg/kg every 12 weeks. If the patient was clinically stable with inactive disease for another 24 additional weeks, canakinumab treatment was discontinued.
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Drug: ACZ885 150 mg (Canakinumab)
Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.
Other Name: ACZ885 150 mg |
- Number of Participants in Clinical Remission on Canakinumab Who Are Able to Remain at an Initial Reduced Canakinumab Dose or Prolonged Canakinumab Dose Interval. [ Time Frame: baseline to 24 weeks ]
The primary efficacy variable for Part II was the proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who were able to remain on a reduced dose or on prolonged dose interval for at least 24 consecutive weeks. As the primary objective was to show statistically significance in at least one of canakinumab treatment arms (reduced dose and prolonged dose interval arms) in Part II then the Type I error rate 5% was controlled and split to 2.5%. Clinical remission per protocol is defined as the maintenance of inactive disease for at least 6 months (24consecutive weeks) while on therapy. The primary analysis considered both inactive disease status and the patient dose step duration.
In the event the inactive disease status was missing, yet the patient remained at the same dose level through the next visit with the same disease status, it was concluded that inactive disease was maintained during this time period and was carried forward.
- Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 1 [ Time Frame: During study parts I and II. The estimated study duration is not more than 216 weeks (with an average expected duration of 108 weeks). ]AEs, Deaths, other serious adverse events or discontinuations due to AE, Part I (Safety set)
- Number and Percentage of Patients With Adverse Events as a Measure of Long-term Safety and Tolerability of Canakinumab - PART 2 [ Time Frame: During study parts I and II, estimated study duration was not more than 216 weeks (with an average duration of 108 weeks). ]AEs, Deaths, other serious adverse events or discontinuations due to AE, Part II (Safety set)
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| Ages Eligible for Study: | 2 Years to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Cohort 1:
• Patients who are receiving canakinumab treatment (4 mg/kg every 4 weeks) for Systemic Juvenile Idiopathic Arthritis (SJIA) and have inactive disease at the last visit in Study CACZ885G2301E1
Cohort 2:
- Confirmed diagnosis of SJIA as per International League Against Rheumatism (ILAR) definition that must have occurred at least 2 months prior to enrollment with an onset of disease < 16 years of age.
- Active SJIA defined as having 2 or more of the following:
- Documented spiking, intermittent fever (body temperature > 38°C) for at least 1 day within 1 week before first canakinumab dose;
- At least 2 joints with active arthritis
- C-reactive protein (CRP) > 30 mg/L (normal range < 10 mg/L)
- Rash due to SJIA
- Serositis
- Lymphadenopathy
- Hepatosplenomegaly
- Negative TB screen (QuantiFERON or, if required by local guidelines, Purified Protein Derivative).
Exclusion Criteria:
- With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection.
- With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and /or places the patient at unacceptable risk for participation.
- With neutropenia (absolute neutrophil count < 1500/mm3) at screening.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296424
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| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02296424 History of Changes |
| Other Study ID Numbers: |
CACZ885G2306 2013-004867-29 ( EudraCT Number ) |
| First Posted: | November 20, 2014 Key Record Dates |
| Results First Posted: | July 9, 2019 |
| Last Update Posted: | July 9, 2019 |
| Last Verified: | June 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Juvenile Rheumatoid arthritis (JRA) chronic systemic inflammatory disorder painful joints inflammation of the synovial membrane |
auto-immune rheumatoid disease reactive rheumatoid arthritis Systemic Juvenile Rheumatoid arthritis (SJRA) |
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Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |