A Study of Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01734382
First received: November 22, 2012
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinet ics, pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in r educed dose frequency in patients with adequately controlled systemic juvenile i diopathic arthritis who have experienced a laboratory abnormality on twice weekl y RoActemra/Actemra dosing. Patients will receive RoActemra/Actemra 12 mg/kg or 8 mg/kg intravenously every 3 weeks. After 4 consecutive infusions, patients who experience an event of neutropenia, thrombocytopenia or liver enzyme abnormalit y will move to every 4 weeks RoActemra/Actemra administration. Anticipated time on study treatment is 52 weeks.


Condition Intervention Phase
Juvenile Idiopathic Arthritis
Drug: tocilizumab [RoActemra/Actemra]
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IV Study to Evaluate Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis (SJIA) Who Experience Laboratory Abnormalities During Treatment With Tocilizumab

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Efficacy: Juvenile Arthritis Disease Activity Score (JADAS-71) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Occurrence of juvenile idiopathic arthritis (JIA) flares [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacodynamics: Interleukin-6/C-reactive protein serum concentrations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Immunogenicity: Anti-tocilizumab antibodies [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Patients reported outcomes: Childhood Health Assessment Questionnaire (CHAQ) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Patient reported outcomes: Parent/patient global assessment of disease activity [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RoActemra/Actemra Q3W Drug: tocilizumab [RoActemra/Actemra]
12 mg/kg (for patients < 30 kg) or 8 mg/kg (for patients </= 30 kg) iv every 3 weeks, up to 52 weeks
Experimental: RoActemra/Actemra Q4W Drug: tocilizumab [RoActemra/Actemra]
Following 4 consecutive 3-weekly infusions: 12 mg/kg (for patients < 30 kg) or 8 mg/kg (for patients </= 30 kg) iv every 4 weeks, up to 40 weeks

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children 2 to 17 years of age inclusive at screening
  • Systemic juvenile idiopathic arthritis (sJIA) according to International League of Associations for Rheumatology (ILAR) classification (2001)
  • JADAS-71 score of 3.8 or less and absence of fever (related to sJIA) at screening and baseline
  • Neutropenia, thrombocytopenia, or elevated ALT/AST previously experienced on the labeled dose (Q2W) of RoActemra/Actemra at any time
  • Must meet one of the following:

Not receiving methotrexate (MTX) or discontinued MTX at least 4 weeks prior to baseline visit, or Taking MTX for at least 12 weeks immediately prior to the baseline visit and on a stable dose of </= 20 mg/m2 for at least 8 weeks prior to the baseline visit, together with either folic acid or folinic acid according to local standard of care

  • Not currently receiving oral corticosteroids, or taking oral corticosteroids at a stable dose for a minimum of 2 weeks prior to baseline visit at no more than 10 mg/day or 0.2 mg/kg/day, whichever is less
  • Not taking non-steroidal anti-inflammatory drug (NSAIDs), or taking no more than 1 type of NSAID at a stable dose for a minimum of 2 weeks prior to the baseline visit, with the dose being less than or equal to the maximum recommended daily dose

Exclusion Criteria:

  • Wheelchair bound or bedridden
  • Any other auto-immune, rheumatic disease, or overlap syndrome other than sJIA
  • Pregnant or lactating, or intending to become pregnant during study conduct and up to 12 weeks after the last administration of study drug
  • Any significant concurrent medical or surgical condition which would jeopardize the patient's safety or ability to complete the trial
  • History of significant allergic or infusion reactions to prior RoActemra/Actemra infusion, and/or presence of anti-tocilizumab antibodies at screening
  • Inborn conditions characterized by a compromised immune system
  • Known HIV infection or other acquired forms of immune compromise
  • Any active acute, subacute, chronic or recurrent bacterial, viral, or systemic fungal infection
  • History of atypical tuberculosis (TB)
  • Active TB requiring treatment within 2 years prior to the screening visit
  • Positive for hepatitis B or hepatitis C infection
  • Chronic hepatitis, viral or autoimmune
  • Significant cardiac or pulmonary disease
  • History of or current cancer or lymphoma
  • Uncontrolled diabetes mellitus
  • History of or concurrent serious gastrointestinal disorders
  • History of macrophage activation syndrome (MAS) within 3 months prior to screening visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01734382

Contacts
Contact: Reference Study ID Number: WA28029 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

Locations
Argentina
Recruiting
Buenos Aires, Argentina, 1270
Not yet recruiting
Buenos Aires, Argentina, 1425
Canada, Alberta
Recruiting
Calgary, Alberta, Canada, T3B 6A8
Canada, Ontario
Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Germany
Recruiting
Berlin, Germany, 13353
Terminated
Frankfurt/Main, Germany, 60316
Recruiting
Sankt Augustin, Germany, 53757
Italy
Recruiting
Roma, Lazio, Italy, 00165
Recruiting
Genova, Liguria, Italy, 16147
Recruiting
Padova, Veneto, Italy, 35128
Mexico
Not yet recruiting
Mexico City, Mexico, 06720
Recruiting
Miexico City, Mexico, 06700
Spain
Recruiting
Madrid, Spain, 28046
Active, not recruiting
Madrid, Spain, 28034
Sweden
Recruiting
Stockholm, Sweden, SE-171 76
United Kingdom
Recruiting
Liverpool, United Kingdom, L12 2AP
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01734382     History of Changes
Other Study ID Numbers: WA28029, 2012-000444-10
Study First Received: November 22, 2012
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014