A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) (JIGSAW 117)
16. mai 2017 oppdatert av: Hoffmann-La Roche
A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
52
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Buenos Aires, Argentina, 1270
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New South Wales
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Westmead, New South Wales, Australia, 2145
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Victoria
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Parkville, Victoria, Australia, 3052
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RJ
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Rio de Janeiro, RJ, Brasil, 20551-030
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Rio de Janeiro, RJ, Brasil, 21941-912
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SP
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Sao Paulo, SP, Brasil, 05403-000
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Sao Paulo, SP, Brasil, 22793-080
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Alberta
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Calgary, Alberta, Canada, T3B 6A8
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Ontario
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Ottawa, Ontario, Canada, K1H 8L1
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Toronto, Ontario, Canada, M5G 1X8
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Moscow, Den russiske føderasjonen, 115522
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Moscow, Den russiske føderasjonen, 119991
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Connecticut
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Hartford, Connecticut, Forente stater, 06106
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Illinois
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Chicago, Illinois, Forente stater, 60637
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Chicago, Illinois, Forente stater, 60611
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New Jersey
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Hackensack, New Jersey, Forente stater, 07601
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North Carolina
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Charlotte, North Carolina, Forente stater, 28203
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Durham, North Carolina, Forente stater, 27710
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Ohio
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Cincinnati, Ohio, Forente stater, 45229-3039
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Oklahoma
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Tulsa, Oklahoma, Forente stater, 74135
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Utah
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Salt Lake City, Utah, Forente stater, 84109
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Washington
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Seattle, Washington, Forente stater, 98105
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Le Kremlin Bicêtre, Frankrike, 94275
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Lazio
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Roma, Lazio, Italia, 00165
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Liguria
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Genova, Liguria, Italia, 16147
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Toscana
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Firenze, Toscana, Italia, 50139
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Monterrey, Mexico, 64460
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Madrid, Spania, 28046
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Madrid, Spania, 28034
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Barcelona
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Esplugas de Llobregat, Barcelona, Spania, 08950
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Bristol, Storbritannia, BS2 8BJ
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Liverpool, Storbritannia, L12 2AP
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Berlin, Tyskland, 13353
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Freiburg, Tyskland, 79106
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Sankt Augustin, Tyskland, 53757
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
1 år til 17 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Ages 1 year (12 years for participants in Russia) up to and including 17 years at screening
- Diagnosis of pJIA according to International League of Associations for Rheumatology classification
- Rheumatoid factor (RF)-positive pJIA
- RF-negative pJIA
- Extended oligoarticular JIA with a polyarticular course
- History of inadequate clinical response (in the opinion of the treating physician) to or inability to tolerate methotrexate (MTX)
- Participants currently receiving TCZ by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV TCZ and should have their first dose of SC TCZ administered on the date that their next IV TCZ infusion would be due. Participants participating in the study may be either naive to TCZ therapy or may be switching from IV to SC. The total number of participants switching from IV TCZ must account for no more than 50 percent (%) of the total participant number. To account for the baseline TCZ concentrations in these participants, information on the last 4 IV TCZ infusions prior to baseline will be collected
- Concurrent treatment with disease-modifying antirheumatic drugs (DMARDs) (including MTX), nonsteroidal anti-inflammatory drugs (NSAIDs), and oral corticosteroids are permitted at the discretion of the investigator
- Females of childbearing potential and non-sterile males with female partner of childbearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria:
- Prior discontinuation of IV TCZ because of inadequate clinical response or safety events (including hypersensitivity)
- Participants with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ
- pJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score 71 [JADAS-71] less than or equal to (< / =) 3.8)
- Participants who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than the permitted pcJIA subsets
- Lack of recovery from recent surgery or an interval of <6 weeks since surgery at the time of the screening visit
- Females who are pregnant, lactating, or intending to become pregnant during study conduct
- Any significant concurrent medical or surgical condition that would jeopardize the participant's safety or ability to complete the study
- Known human immunodeficiency virus (HIV) infection or other acquired forms of immune compromise or inborn conditions characterized by a compromised immune system
- History of alcohol, drug, or chemical abuse within 6 months of screening
- Any active acute, subacute, chronic, or recurrent bacterial, viral, or systemic fungal infection or any major episode of infection requiring hospitalization or treatment during screening or treatment with IV antibiotics completed within 4 weeks of the screening visit or oral antibiotics completed within 2 weeks of the screening visit
- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening visit
- Positive purified protein derivative (PPD) at screen, unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug and chest radiograph is negative for active TB within 6 months of screening visit according to local practice
- History of reactivation or new onset of a systemic infection such as herpes zoster or Epstein-Barr virus within 2 months of the screening visit
- Hepatitis B surface antigen or hepatitis C antibody positivity or chronic viral or autoimmune hepatitis
- History of concurrent serious gastrointestinal disorders such as ulcer or inflammatory bowel disease, Crohn's disease, ulcerative colitis, or other symptomatic lower gastrointestinal conditions
- History of or current cancer or lymphoma
- Uncontrolled diabetes mellitus with elevated glycosylated hemoglobin
- Active uveitis at screening
- Inadequate hematologic, renal or liver function
- Prior stem cell transplant at any time
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: TCZ SC 162 mg Q3W
Participants with body weight less than (<) 30 kilograms (kg) will be administered 162 milligrams (mg) of TCZ as a SC injection every 3 weeks (Q3W) for 52 weeks.
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Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Andre navn:
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Eksperimentell: TCZ SC 162 mg Q2W
Participants with body weight greater than or equal to (>/=) 30 kg will be administered 162 mg of TCZ as a SC injection every 2 weeks (Q2W) for 52 weeks.
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Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Minimum Serum Concentration (Cmin) of TCZ at Steady State
Tidsramme: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, 2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
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Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
Tidsramme: Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016 hours post Day 1 dose (additionally at 6, 12, 48, 120 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016 post Day 1 dose.
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Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Maximum Serum Concentration (Cmax) of TCZ at Steady State
Tidsramme: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Detailed timeframe for TCZ SC 162 mg Q3W arm: pre-dose (Hour 0), 96, 504, 1008, 2016, 2022, 2064, 2112, ,2160, 2520 hours post Day 1 dose (additionally at 6, 12, 48, 120, 2028 hours post Day 1 dose in participants >/=2 years old).
Detailed timeframe for TCZ SC 162 mg Q2W arm: pre-dose (Hour 0), 6, 12, 48, 120, 336, 672, 1008, 2016, 2022, 2028, 2040, 2064, 2112, 2160, 2520 hours post Day 1 dose.
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Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Tidsramme: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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IL-6 is a cytokine associated with disease activity in juvenile idiopathic arthritis (JIA) including the polyarticular juvenile idiopathic arthritis (pJIA) subset.
It is found in high levels in the synovial fluid and is associated with indicators of inflammatory activity.
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Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Change From Baseline in Soluble IL-6 Receptor Levels
Tidsramme: Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Baseline, Days 0.25, 0.5, 2, 4, 5, 84.25, 84.5, 85, 86, 88, 90; Weeks 2, 3, 4, 6, 12, 14, 15, 27, 28, 36, 44, 52
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Change From Baseline in C-Reactive Protein (CRP) Levels
Tidsramme: Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
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Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
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Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Tidsramme: Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
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The ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline indicates improvement.
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Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
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Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
Tidsramme: Baseline up to Week 52
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Baseline up to Week 52
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Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2013
Primær fullføring (Faktiske)
1. mai 2016
Studiet fullført (Faktiske)
1. mai 2016
Datoer for studieregistrering
Først innsendt
14. juni 2013
Først innsendt som oppfylte QC-kriteriene
17. juli 2013
Først lagt ut (Anslag)
22. juli 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. juni 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. mai 2017
Sist bekreftet
1. mai 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- WA28117
- 2012-003486-18 (EudraCT-nummer)
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Nei
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