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Juvenile Idiopathic ArthritisPhase 1JIGSAW 117NCT01904279

A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)

A Phase 1 study testing Tocilizumab in people with Juvenile Idiopathic Arthritis, run by Hoffmann-La Roche at 35 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA. 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
35 sitesin 12 countries
Study dates
Jul 2013to May 2016
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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)
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  • 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

Who cannot join

  • 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
Show all 21Show 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 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

Trial locations and contacts

35 sites in 12 countries.

35 sites in 12 countries

United States10 sites

  • Study site

    Charlotte, North Carolina, 28203

  • Study site

    Chicago, Illinois, 60611

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45229-3039

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hartford, Connecticut, 06106

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Seattle, Washington, 98105

  • Study site

    Tulsa, Oklahoma, 74135

Other trials in United States

Brazil4 sites

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Study site

    Rio de Janeiro, Rio de Janeiro, 21941-912

  • Study site

    São Paulo, São Paulo, 05403-000

  • Study site

    São Paulo, São Paulo, 22793-080

Other trials in Brazil

Canada3 sites

  • Study site

    Calgary, Alberta, T3B 6A8

  • Study site

    Ottawa, Ontario, K1H 8L1

  • Study site

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Germany3 sites

  • Study site

    Berlin, 13353

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Sankt Augustin, 53757

Other trials in Germany

Italy3 sites

  • Study site

    Florence, Tuscany, 50139

  • Study site

    Genoa, Liguria, 16147

  • Study site

    Rome, Lazio, 00165

Other trials in Italy

Spain3 sites

  • Study site

    Esplugas de Llobregat, Barcelona, 08950

  • Study site

    Madrid, 28034

  • Study site

    Madrid, 28046

Other trials in Spain

Australia2 sites

  • Study site

    Parkville, Victoria, 3052

  • Study site

    Westmead, New South Wales, 2145

Other trials in Australia

Russia2 sites

  • Study site

    Moscow, 115522

  • Study site

    Moscow, 119991

Other trials in Russia

United Kingdom2 sites

  • Study site

    Bristol, BS2 8BJ

  • Study site

    Liverpool, L12 2AP

Other trials in United Kingdom

Argentina1 site

  • Study site

    Buenos Aires, 1270

Other trials in Argentina

France1 site

  • Study site

    Le Kremlin-Bicêtre, 94275

Other trials in France

Mexico1 site

  • Study site

    Monterrey, 64460

Other trials in Mexico

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 Polyarticular Juvenile Idiopathic Arthritis

This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.

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

    Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks

Study groups in NCT01904279
Study groupRoleWhat they receive
TCZ SC 162 mg Q3WExperimentalParticipants 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.
Receives: Drug: Tocilizumab
TCZ SC 162 mg Q2WExperimentalParticipants 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.
Receives: Drug: Tocilizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Minimum Serum Concentration (Cmin) of TCZ at Steady State

    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.

    Measured: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)

  2. Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment

    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.

    Measured: Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)

  3. Maximum Serum Concentration (Cmax) of TCZ at Steady State

    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.

    Measured: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)

Secondary outcomes (5)

  1. Change From Baseline in Serum Interleukin-6 (IL-6) Levels

    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.

    Measured: 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

  2. Change From Baseline in Soluble IL-6 Receptor Levels

    Measured: 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

  3. Change From Baseline in C-Reactive Protein (CRP) Levels

    Measured: Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52

  4. Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

    The ESR is an acute phase reactant and a measure of inflammation. A negative change from baseline indicates improvement.

    Measured: Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52

  5. Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential

    Measured: Baseline up to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01904279
Sponsor's protocol ID
WA28117
Other IDs
2012-003486-18
Acronym
JIGSAW 117
Status last verified
May 2017
First submitted
14 Jun 2013
Last updated
14 Jun 2017

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

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 35 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 9 inclusion and 21 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in United States, Brazil, Canada, Germany, Italy 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?

Yes. Results are posted in the registry (first posted 16 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Minimum Serum Concentration (Cmin) of TCZ at Steady State (time frame: Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)). 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 NCT01904279, 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 14 Jun 2017.

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