Trial record 13 of 935 for:
Open Studies | "Arthritis"
A Study of RoActemra/Actemra (Tocilizumab) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis
This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01455701
First received: October 18, 2011
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
This study will investigate the pharmacokinetics and safety of RoActemra/Actemra (tocilizumab) in patients less than 2 years old with active systemic juvenile idiopathic arthritis. Patients will receive RoActemra/Actemra infusions every 2 weeks. The anticipated time on study treatment is 12 weeks.
| Condition | Intervention | Phase |
|---|---|---|
|
Juvenile Idiopathic Arthritis, Rheumatoid Arthritis |
Drug: Tocilizumab [RoActemra/Actemra] |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA) |
Resource links provided by NLM:
Genetics Home Reference related topics:
juvenile idiopathic arthritis
Drug Information available for:
Tocilizumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Pharmacokinetics (plasma concentration of tocilizumab) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Safety (incidence of adverse events) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | August 2016 |
| Estimated Primary Completion Date: | August 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single Arm |
Drug: Tocilizumab [RoActemra/Actemra]
Tocilizumab infusions every 2 weeks for 12 weeks
|
Eligibility| Ages Eligible for Study: | up to 24 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients, less than 24 months old at baseline
- Diagnosis of systemic juvenile idiopathic arthritis (sJIA)
- Duration of systemic juvenile idiopathic arthritis (sJIA) lasting at least 3 months since the onset of sJIA symptoms
- Presence of active disease
- Uncontrolled disease despite treatment with non-steroidal anti-inflammatory drugs and corticosteroids
Exclusion Criteria:
- Any other auto-immune, rheumatic disease or overlap syndrome other than systemic juvenile idiopathic arthritis
- Not fully recovered from recent surgery or less than 6 weeks since surgery at the time of screening visit, or planned surgery during study
- Any significant concurrent medical or surgical condition which would jeopardize the patient's safety
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455701
Contacts
| Contact: Please reference Study ID Number: NP25737 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| United States, California | |
| Recruiting | |
| San Francisco, California, United States, 94117 | |
| United States, District of Columbia | |
| Recruiting | |
| Washington, District of Columbia, United States, 20010-2970 | |
| United States, Illinois | |
| Recruiting | |
| Chicago, Illinois, United States, 60649 | |
| United States, Kentucky | |
| Recruiting | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| Not yet recruiting | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Nevada | |
| Recruiting | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, New Jersey | |
| Recruiting | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, Ohio | |
| Recruiting | |
| Cincinnati, Ohio, United States, 45229-3039 | |
| United States, Pennsylvania | |
| Recruiting | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| Argentina | |
| Recruiting | |
| Buenos Aires, Argentina, 1270 | |
| Canada, Alberta | |
| Recruiting | |
| Calgary, Alberta, Canada, T3B 6A8 | |
| Canada, Ontario | |
| Recruiting | |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Canada, Quebec | |
| Recruiting | |
| Montreal, Quebec, Canada, H3H 1P3 | |
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: | NCT01455701 History of Changes |
| Other Study ID Numbers: | NP25737 |
| Study First Received: | October 18, 2011 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Arthritis, Juvenile Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013