Juvenile Idiopathic ArthritisPhase 1NCT01904292
A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis
A Phase 1 study testing Tocilizumab in people with Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche at 42 sites in 12 countries.
Trial summary
This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 42 sitesin 12 countries
- Study dates
- 15 Aug 2013to 13 Jun 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of sJIA according to the International League of Associations for Rheumatology (ILAR) classification
- History of inadequate clinical response (in the opinion of the treating physician) to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids
- If a participant has received previous treatment with any biologic agents other than tocilizumab, these must have been discontinued according to the timelines defined by protocol prior to the baseline visit
- Participants currently receiving tocilizumab by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV tocilizumab and should have their first dose of SC tocilizumab administered on the date that their next IV tocilizumab infusion would be due
- Concurrent treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), NSAIDs, and oral corticosteroids are permitted at the discretion of the investigator
- Participants of reproductive potential must be willing to use highly effective contraceptive methods
Who cannot join
- Prior discontinuation of IV tocilizumab 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 tocilizumab
- sJIA that is well controlled by any treatment agent other than tocilizumab (Juvenile Arthritis Disease Activity Score of 71 Joints [JADAS-71] less than or equal to [<=] 3.8 with no fever)
- Participants who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA
- Lack of recovery from recent surgery or an interval of <6 weeks since surgery at the time of the screening visit
Show all 20Show fewer
- 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 TB test at screening unless treated with anti-TB therapy for at least 4 weeks prior to receiving study drug
- 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
- Macrophage activation syndrome (MAS) within 3 months of the screening visit
- Inadequate hematologic, renal or liver function
Trial locations and contacts
42 sites in 12 countries.
42 sites in 12 countries
United States11 sites
Levine Children's Hospital; Divison of Pediatric Rheumatology; Department of Pediatrics
Charlotte, North Carolina, 28203
Ann & Robert H. Lurie Children's Hospital of Chicago; Division of Rheumatology
Chicago, Illinois, 60611
The University of Chicago;Department of Pediatrics
Chicago, Illinois, 60649
Cincinnati Children'S Hospital Medical Center; Division of Rheumatology
Cincinnati, Ohio, 45229-3039
Cleveland Clinic Fndn
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27710
Hackensack University Medical Center; Pediatric Rheumatology
Hackensack, New Jersey, 07601
Connecticut Children's Medical Center; 5E Clinical Trials Unit
Hartford, Connecticut, 06106
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, 72202
University of Utah; Immunology/Rheumatology/Allergy
Salt Lake City, Utah, 84109
Seattle Children's Hospital
Seattle, Washington, 98105
Spain5 sites
Hospital Sant Joan De Deu; Servicio de Reumatologia Pediatrica
Esplugas de Llobregat, Barcelona, 08950
Hospital Infantil Universitario Niño Jesus, Servicio Reumatologia
Madrid, 28009
Hospital Ramon y Cajal ; Servicio de Reumatologia
Madrid, 28034
Hospital de La Paz; Unidad de Reumatologia Pediatrica
Madrid, 28046
Hospital Universitario la Fe: Servicio de Reumatologia Pediatrica
Valencia, 46026
United Kingdom4 sites
Bristol Royal Hospital For Children
Bristol, BS2 8BJ
Alder Hey Children's NHS Foundation Trust
Liverpool, L12 2AP
Great Ormond Street Hospital; Somers Clinical Research Facility
London, WC1N 3JH
Nottingham Children's Hospital
Nottingham, NG7 2UH
Brazil3 sites
Hospital das Clinicas - FMUSP Ribeirao Preto; Pediatria - Imunologia e Reumatologia
Ribeirão Preto, São Paulo, 14048-900
Hospital das Clinicas - FMUSP; Instituto da Crianca - Reumatologia
São Paulo, São Paulo, 05403-000
Universidade Federal de Sao Paulo - UNIFESP
São Paulo, São Paulo, 22793-080
Canada3 sites
Alberta Children'S Hospital
Calgary, Alberta, T3B 6A8
Children'S Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Hospital For Sick Children
Toronto, Ontario, M5G 1X8
Germany3 sites
Charité Campus; Virchow Klinikum Berlin
Berlin, 13353
Uniklinikum Freiburg Zentrum für Kinder- und Jugendmedizin; Pädiatrische Infektio- u. Rheumatologie
Freiburg im Breisgau, 79106
Asklepios Klinik; Zentrum fuer Allgemeine Paediatrie und Neonatologie
Sankt Augustin, 53757
Italy3 sites
Nuovo Ospedale Pediatrico Meyer; Reumatologia - Clinica Pediatrica 1°
Florence, Tuscany, 50139
Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS
Genoa, Liguria, 16147
Irccs Ospedale Pediatrico Bambin Gesu - Dip. Di Medicina
Rome, Lazio, 00165
Mexico3 sites
Hospital Infantil de México "Federico Gomez"; Rheumatology
México, 06720
Cliditer SA de CV
Miexico City, 06700
Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria
Monterrey, 64460
Argentina2 sites
Hospital Gral de Niños Pedro Elizalde
Buenos Aires, 1270
Hospital de Ninos de la Santisima Trinidad; Reumatologia Infantil
Córdoba, 5000
Australia2 sites
Royal Children'S Hospital; Paediatric Rheumatology
Parkville, Victoria, 3052
Westmead Hospital; Paediatric Rheumatology
Westmead, New South Wales, 2145
Russia2 sites
FSBI "Scientific Research Institute of Rheumatology" of russian Academy of Medical Sciences
Moscow, 115522
SI Sceintific children health center RAMS
Moscow, 119991
About this study
Official title: A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis
This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.
- Conditions
- Juvenile Idiopathic Arthritis
- Being tested
- Tocilizumab
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra/Actemra
Subcutaneous 162 mg dose QW or Q2W for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab | Experimental | Participants will receive SC dose of tocilizumab based on body weight; participants with <30 kg will receive 162 milligrams (mg) of tocilizumab Q2W and those participants =>30 kg will receive 162 mg of tocilizumab QW, for 52 weeks. Receives: Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab
Measured: Age <2 years: 0 hours(h) on Days(D) 0,84; on D5,14,42,70,85,88,98,182,266, 364. Weight <30kg, Age>=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266, 364
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Tocilizumab
Measured: Age <2 years: 0h on D0,84; on D5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30 kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacokinetics: Minimum Plasma Concentration (Cmin) of Tocilizumab
Measured: Weight <30 kg: predose (0h) on Days 0 and 84. Weight >= 30 kg: predose (0h) on Days 0 and 91
Secondary outcomes (6)
Pharmacodynamics: Serum Interleukin-6 (IL6) Levels
Measured: Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacodynamics: Soluble IL-6 Receptor (sIL-6R) Levels
Measured: Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacodynamics: Serum C-Reactive Protein (CRP) Levels
Measured: Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364
Pharmacodynamics: Serum Erythrocyte Sedimentation Rate (ESR)
Measured: Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364
Pharmacodynamics: Percentage of Participants with Anti-Tocilizumab Antibodies
Measured: Age <2 years: Days 0, 84, 182, 266, 364. Weight <30 kg, Age >=2 years: Days 0, 84, 182, 266, 364. Weight >=30 kg: Days 0, 91, 182, 266, 364
Safety: Percentage of Participants with At Least 1 Adverse Event
Measured: 57 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study start15 Aug 2013
- Primary completion13 Jun 2017
- Study completion13 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Juvenile Idiopathic ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904292
- Sponsor's protocol ID
- WA28118
- Other IDs
- 2012-003490-26
- Status last verified
- Nov 2017
- First submitted
- 14 Jun 2013
- Last updated
- 20 Nov 2017
- Results posted
- No
Publications
Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Perez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047.
PubMed 33506875
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis
- ClinicalTrials.gov ID
- NCT01904292
- Acronym / sponsor ID
- WA28118
- Conditions
- Juvenile Idiopathic Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2013 (actual)
- Primary completion
- 13 Jun 2017 (actual)
- Study completion
- 13 Jun 2017 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight <30 kg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab | Experimental | Drug: TocilizumabParticipants will receive SC dose of tocilizumab based on body weight; participants with <30 kg will receive 162 milligrams (mg) of tocilizumab Q2W and those participants =>30 kg will receive 162 mg of tocilizumab QW, for 52 weeks. |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of sJIA according to the International League of Associations for Rheumatology (ILAR) classification
- History of inadequate clinical response (in the opinion of the treating physician) to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids
- If a participant has received previous treatment with any biologic agents other than tocilizumab, these must have been discontinued according to the timelines defined by protocol prior to the baseline visit
- Participants currently receiving tocilizumab by the intravenous (IV) route of administration and with well-controlled disease do not require a period of discontinuation of IV tocilizumab and should have their first dose of SC tocilizumab administered on the date that their next IV tocilizumab infusion would be due
- Concurrent treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) including methotrexate (MTX), NSAIDs, and oral corticosteroids are permitted at the discretion of the investigator
Key exclusion criteria (20 listed)
- Prior discontinuation of IV tocilizumab 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 tocilizumab
- sJIA that is well controlled by any treatment agent other than tocilizumab (Juvenile Arthritis Disease Activity Score of 71 Joints [JADAS-71] less than or equal to [<=] 3.8 with no fever)
- Participants who are wheelchair-bound or bedridden
- Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabAlso: RoActemra/ActemraSubcutaneous 162 mg dose QW or Q2W for 52 weeks | Drug | Tocilizumab |
Primary outcome
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab
Time frame: Age <2 years: 0 hours(h) on Days(D) 0,84; on D5,14,42,70,85,88,98,182,266, 364. Weight <30kg, Age>=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266, 364
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Tocilizumab
Time frame: Age <2 years: 0h on D0,84; on D5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30 kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacokinetics: Minimum Plasma Concentration (Cmin) of Tocilizumab
Time frame: Weight <30 kg: predose (0h) on Days 0 and 84. Weight >= 30 kg: predose (0h) on Days 0 and 91
6 secondary outcomes
Pharmacodynamics: Serum Interleukin-6 (IL6) Levels
Time frame: Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacodynamics: Soluble IL-6 Receptor (sIL-6R) Levels
Time frame: Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacodynamics: Serum C-Reactive Protein (CRP) Levels
Time frame: Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364
Pharmacodynamics: Serum Erythrocyte Sedimentation Rate (ESR)
Time frame: Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364
Pharmacodynamics: Percentage of Participants with Anti-Tocilizumab Antibodies
Time frame: Age <2 years: Days 0, 84, 182, 266, 364. Weight <30 kg, Age >=2 years: Days 0, 84, 182, 266, 364. Weight >=30 kg: Days 0, 91, 182, 266, 364
Safety: Percentage of Participants with At Least 1 Adverse Event
Time frame: 57 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2017.
- Derived from this study: PubMed 33506875Ruperto N, Brunner HI, Ramanan AV, Horneff G, Cuttica R, Henrickson M, Anton J, Boteanu AL, Penades IC, Minden K, Schmeling H, Hufnagel M, Weiss JE, Pardeo M, Nanda K, Roth J, Rubio-Perez N, Hsu JC, Wimalasundera S, Wells C, Bharucha K, Douglass W, Bao M, Mallalieu NL, Martini A, Lovell D, Benedetti F; Paediatric Rheumatology INternational Trials Organisation (PRINTO) and the Paediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous dosing regimens of tocilizumab in children with systemic or polyarticular juvenile idiopathic arthritis. Rheumatology (Oxford). 2021 Oct 2;60(10):4568-4580. doi: 10.1093/rheumatology/keab047.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
42 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tocilizumab in people with Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche at 42 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States, Spain, United Kingdom, Brazil, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab (time frame: Age <2 years: 0 hours(h) on Days(D) 0,84; on D5,14,42,70,85,88,98,182,266, 364. Weight <30kg, Age>=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266, 364). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01904292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2017.