A Study of Subcutaneously Administered RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis

Juvenile Idiopathic Arthritis Clinical Trial

Official title:

AN PHASE Ib, OPEN LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION IN PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01904279
• Other study ID #: WA28117
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2013
• Last updated: October 3, 2016
• Start date: July 2013
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis. Patients will receive RoActemra/Actemra subcutaneously every 2 or 3 weeks for 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

Inclusion Criteria:

• Ages 1 year up to and including 17 years at screening

• Diagnosis of polyarticular-course juvenile idiopathic arthritis according to International League of Associations for Rheumatology classification

• Rheumatoid factor (RF)-positive polyarticular JIA (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)

• If a patient has received previous treatment with any biologic agents other than TCZ (tocilizumab), these must have been discontinued according to the timelines defined by protocol prior to the baseline visit

• Patients currently receiving TCZ by the 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.

• Concurrent treatment with DMARDs (including MTX), 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)

• Patients with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ

• pcJIA that is well controlled by any treatment agent other than TCZ (Juvenile Arthritis Disease Activity Score [JADAS]-71 < / = 3.8)

• Patients 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 patient's safety or ability to complete the study

• Known 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

• Active uveitis at screening

• Inadequate hematologic, renal or liver function

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
Subcutaneous doses every 2 or 3 weeks for 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  France,  Germany,  Italy,  Mexico,  Russian Federation,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics: Area under the concentration-time curve (AUC)		14 weeks	No
Primary	Pharmacokinetics: Serum concentrations (Cmin/Cmax)		14 weeks	No
Secondary	Pharmacodynamics: Serum interleukin-6 (IL6)/soluble IL-6 receptor (sIL-6R) levels		14 weeks	No
Secondary	Pharmacodynamics: C-reactive protein (CRP)		52 weeks	No
Secondary	Pharmacodynamics: Erythrocyte sedimentation rate (ESR)		52 weeks	No
Secondary	Pharmacodynamics: Incidence of anti-TCZ antibodies		52 weeks	No
Secondary	Safety: Incidence of adverse events		57 weeks	No