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 December 2015 by Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: November 22, 2012
Last updated: December 1, 2015
Last verified: December 2015
This open-label Phase IV study will evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of RoActemra/Actemra (tocilizumab) in reduced dose frequency in patients with adequately controlled systemic juvenile idiopathic arthritis who have experienced a laboratory abnormality on twice weekly 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 abnormality 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: September 2019
Estimated Primary Completion Date: September 2019 (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


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

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

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

Active, not recruiting
Buenos Aires, Argentina, 1270
Canada, Alberta
Calgary, Alberta, Canada, T3B 6A8
Canada, Ontario
Ottawa, Ontario, Canada, K1H 8L1
Berlin, Germany, 13353
Frankfurt/Main, Germany, 60316
Sankt Augustin, Germany, 53757
Roma, Lazio, Italy, 00165
Genova, Liguria, Italy, 16147
Padova, Veneto, Italy, 35128
Mexico City, Mexico, 06720
Miexico City, Mexico, 06700
Madrid, Spain, 28046
Madrid, Spain, 28034
Stockholm, Sweden, SE-171 76
United Kingdom
Liverpool, United Kingdom, L12 2AP
Sponsors and Collaborators
Hoffmann-La Roche
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: December 1, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on February 09, 2016