A Study of Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)
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Purpose
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 |
- 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 ]
- 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: | August 2016 |
| Estimated Primary Completion Date: | August 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 |
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| Contact: Please reference Study ID Number: WA28029 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
| Argentina | |
| Not yet recruiting | |
| Buenos Aires, Argentina, 1270 | |
| Not yet recruiting | |
| Buenos Aires, Argentina, 1425 | |
| Canada, Alberta | |
| Recruiting | |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Canada, Ontario | |
| Not yet recruiting | |
| Ottawa, Ontario, Canada, K1H 8L1 | |
| Germany | |
| Recruiting | |
| Berlin, Germany, 13353 | |
| Recruiting | |
| Frankfurt/main, Germany, 60316 | |
| Recruiting | |
| Sankt Augustin, Germany, 53757 | |
| Italy | |
| Not yet recruiting | |
| Genova, Italy, 16147 | |
| Not yet recruiting | |
| Milano, Italy, 20122 | |
| Not yet recruiting | |
| Padova, Italy, 35128 | |
| Not yet recruiting | |
| Roma, Italy, 00165 | |
| Mexico | |
| Not yet recruiting | |
| Mexico, Mexico, 06700 | |
| Not yet recruiting | |
| Mexico City, Mexico, 06720 | |
| Not yet recruiting | |
| Monterrey, Mexico, 64460 | |
| Norway | |
| Not yet recruiting | |
| Oslo, Norway, 0372 | |
| Spain | |
| Not yet recruiting | |
| Madrid, Spain, 28046 | |
| Not yet recruiting | |
| Madrid, Spain, 28034 | |
| Sweden | |
| Recruiting | |
| Stockholm, Sweden, SE-171 76 | |
| United Kingdom | |
| Not yet recruiting | |
| Liverpool, United Kingdom, L12 2AP | |
| 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: | March 22, 2013 |
| 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 May 21, 2013