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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01904279




Registration number
NCT01904279
Ethics application status
Date submitted
14/06/2013
Date registered
22/07/2013
Date last updated
14/06/2017

Titles & IDs
Public title
A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)
Scientific 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
Secondary ID [1] 0 0
2012-003486-18
Secondary ID [2] 0 0
WA28117
Universal Trial Number (UTN)
Trial acronym
JIGSAW 117
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Juvenile Idiopathic Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tocilizumab

Experimental: 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.

Experimental: 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.


Treatment: Drugs: Tocilizumab
Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Minimum Serum Concentration (Cmin) of TCZ at Steady State
Timepoint [1] 0 0
Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
Primary outcome [2] 0 0
Area Under the Curve at Steady-state Over a 12-week Interval (AUC12weeks) of TCZ Treatment
Timepoint [2] 0 0
Pre-dose (Hour 0) up to 2016 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
Primary outcome [3] 0 0
Maximum Serum Concentration (Cmax) of TCZ at Steady State
Timepoint [3] 0 0
Pre-dose (Hour 0) up to 2520 hours post Day 1 dose (detailed timeframe is provided in outcome description section)
Secondary outcome [1] 0 0
Change From Baseline in Serum Interleukin-6 (IL-6) Levels
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Change From Baseline in Soluble IL-6 Receptor Levels
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Change From Baseline in C-Reactive Protein (CRP) Levels
Timepoint [3] 0 0
Baseline, Weeks 4, 6, 9, 12,18, 20, 27, 28, 36, 44, 45, 51, 52
Secondary outcome [4] 0 0
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Timepoint [4] 0 0
Baseline, Week 4, 6, 9, 12, 18, 20, 27, 28, 36, 44, 45, 51, 52
Secondary outcome [5] 0 0
Percentage of Participants With Anti-TCZ Antibodies of Neutralizing Potential
Timepoint [5] 0 0
Baseline up to Week 52

Eligibility
Key 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
Minimum age
1 Year
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
- Westmead
Recruitment hospital [2] 0 0
- Parkville
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New Jersey
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Oklahoma
Country [7] 0 0
United States of America
State/province [7] 0 0
Utah
Country [8] 0 0
United States of America
State/province [8] 0 0
Washington
Country [9] 0 0
Argentina
State/province [9] 0 0
Buenos Aires
Country [10] 0 0
Brazil
State/province [10] 0 0
RJ
Country [11] 0 0
Brazil
State/province [11] 0 0
SP
Country [12] 0 0
Canada
State/province [12] 0 0
Alberta
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
France
State/province [14] 0 0
Le Kremlin Bicêtre
Country [15] 0 0
Germany
State/province [15] 0 0
Berlin
Country [16] 0 0
Germany
State/province [16] 0 0
Freiburg
Country [17] 0 0
Germany
State/province [17] 0 0
Sankt Augustin
Country [18] 0 0
Italy
State/province [18] 0 0
Lazio
Country [19] 0 0
Italy
State/province [19] 0 0
Liguria
Country [20] 0 0
Italy
State/province [20] 0 0
Toscana
Country [21] 0 0
Mexico
State/province [21] 0 0
Monterrey
Country [22] 0 0
Russian Federation
State/province [22] 0 0
Moscow
Country [23] 0 0
Spain
State/province [23] 0 0
Barcelona
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Bristol
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Liverpool

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and
safety of SC administered TCZ in participants with pJIA.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01904279
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01904279