A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA) (JIGSAW 117)
16 maj 2017 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
52
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Buenos Aires, Argentina, 1270
-
-
-
-
New South Wales
-
Westmead, New South Wales, Australien, 2145
-
-
Victoria
-
Parkville, Victoria, Australien, 3052
-
-
-
-
RJ
-
Rio de Janeiro, RJ, Brasilien, 20551-030
-
Rio de Janeiro, RJ, Brasilien, 21941-912
-
-
SP
-
Sao Paulo, SP, Brasilien, 05403-000
-
Sao Paulo, SP, Brasilien, 22793-080
-
-
-
-
-
Le Kremlin Bicêtre, Frankrike, 94275
-
-
-
-
Connecticut
-
Hartford, Connecticut, Förenta staterna, 06106
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60637
-
Chicago, Illinois, Förenta staterna, 60611
-
-
New Jersey
-
Hackensack, New Jersey, Förenta staterna, 07601
-
-
North Carolina
-
Charlotte, North Carolina, Förenta staterna, 28203
-
Durham, North Carolina, Förenta staterna, 27710
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna, 45229-3039
-
-
Oklahoma
-
Tulsa, Oklahoma, Förenta staterna, 74135
-
-
Utah
-
Salt Lake City, Utah, Förenta staterna, 84109
-
-
Washington
-
Seattle, Washington, Förenta staterna, 98105
-
-
-
-
Lazio
-
Roma, Lazio, Italien, 00165
-
-
Liguria
-
Genova, Liguria, Italien, 16147
-
-
Toscana
-
Firenze, Toscana, Italien, 50139
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T3B 6A8
-
-
Ontario
-
Ottawa, Ontario, Kanada, K1H 8L1
-
Toronto, Ontario, Kanada, M5G 1X8
-
-
-
-
-
Monterrey, Mexiko, 64460
-
-
-
-
-
Moscow, Ryska Federationen, 115522
-
Moscow, Ryska Federationen, 119991
-
-
-
-
-
Madrid, Spanien, 28046
-
Madrid, Spanien, 28034
-
-
Barcelona
-
Esplugas de Llobregat, Barcelona, Spanien, 08950
-
-
-
-
-
Bristol, Storbritannien, BS2 8BJ
-
Liverpool, Storbritannien, L12 2AP
-
-
-
-
-
Berlin, Tyskland, 13353
-
Freiburg, Tyskland, 79106
-
Sankt Augustin, Tyskland, 53757
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
1 år till 17 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Andra namn:
|
|
Experimentell: 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.
|
Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Minimum Serum Concentration (Cmin) of TCZ at Steady State
Tidsram: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
|
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.
|
Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
|
|
Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
Tidsram: Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
|
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.
|
Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
|
|
Maximum Serum Concentration (Cmax) of TCZ at Steady State
Tidsram: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
|
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.
|
Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Tidsram: 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
|
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.
|
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
|
|
Change From Baseline in Soluble IL-6 Receptor Levels
Tidsram: 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
|
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
|
|
|
Change From Baseline in C-Reactive Protein (CRP) Levels
Tidsram: Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
|
Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
|
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Tidsram: Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
|
The ESR is an acute phase reactant and a measure of inflammation.
A negative change from baseline indicates improvement.
|
Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
|
|
Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
Tidsram: Baseline up to Week 52
|
Baseline up to Week 52
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2013
Primärt slutförande (Faktisk)
1 maj 2016
Avslutad studie (Faktisk)
1 maj 2016
Studieregistreringsdatum
Först inskickad
14 juni 2013
Först inskickad som uppfyllde QC-kriterierna
17 juli 2013
Första postat (Uppskatta)
22 juli 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 juni 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
16 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- WA28117
- 2012-003486-18 (EudraCT-nummer)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .