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

NCT ID: NCT01904279

Last Updated: 2017-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2016-05-31

Brief Summary

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

Conditions

Juvenile Idiopathic Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

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

Interventions

Tocilizumab

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

Intervention Type: DRUG

Other Intervention Names

RoActemra/Actemra

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Hartford, Connecticut, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Hackensack, New Jersey, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

Cincinnati, Ohio, United States

Tulsa, Oklahoma, United States

Salt Lake City, Utah, United States

Seattle, Washington, United States

Buenos Aires, , Argentina

Westmead, New South Wales, Australia

Parkville, Victoria, Australia

Rio de Janeiro, Rio de Janeiro, Brazil

Rio de Janeiro, Rio de Janeiro, Brazil

São Paulo, São Paulo, Brazil

São Paulo, São Paulo, Brazil

Calgary, Alberta, Canada

Ottawa, Ontario, Canada

Toronto, Ontario, Canada

Le Kremlin-Bicêtre, , France

Berlin, , Germany

Freiburg im Breisgau, , Germany

Sankt Augustin, , Germany

Rome, Lazio, Italy

Genoa, Liguria, Italy

Florence, Tuscany, Italy

Monterrey, , Mexico

Moscow, , Russia

Moscow, , Russia

Esplugas de Llobregat, Barcelona, Spain

Madrid, , Spain

Madrid, , Spain

Bristol, , United Kingdom

Liverpool, , United Kingdom

Countries

United States; Argentina; Australia; Brazil; Canada; France; Germany; Italy; Mexico; Russia; Spain; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33506875 (View on PubMed)

Other Identifiers

2012-003486-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

WA28117

Identifier Type: -

Identifier Source: org_study_id