A Study of Tocilizumab in Patients With Active Systemic Juvenile Idiopathic Arthritis - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00642460

Purpose

This study will evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate clinical response to NSAIDs and corticosteroids. In Part 1 of the study patients will be randomized 2:1 to receive iv infusions of tocilizumab (8mg/kg iv for patients >=30kg, or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will be continued throughout. After 12 weeks of double-blind treatment, all patients will have the option to enter Part 2 of the study to receive open-label treatment with tocilizumab for a further 92 weeks. The anticipated time on study treatment is 2 years, and the target sample size is 100-500 individuals.

Condition	Intervention	Phase
Juvenile Idiopathic Arthritis	Drug: tocilizumab Drug: Placebo Drug: NSAIDs + methotrexate	Phase III

MedlinePlus related topics: Juvenile Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Placebo-Controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis, With an Open-Label Extension to Examine the Long Term Use of Tocilizumab

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Proportion of patients with >=30% improvement in JIA core set and absence of fever [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

% patients with 30/50/70/90% improvement in JIA core set; reduction in steroid use; change in individual components of JIA core set; change in hsCRP, anemia, platelet count, total WBC, incidence of rash;improvement in CHAQ, and VAS [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Time from baseline to achievement of JIA ACR 30/50/70/90 [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
AEs, lab parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	108
Study Start Date:	May 2008
Estimated Study Completion Date:	June 2011

Arms	Assigned Interventions
1: Experimental	Drug: tocilizumab 8mg/kg (patients>=30kg) or 12mg/kg (patients <30kg) iv every 2 weeks for 12 weeks Drug: NSAIDs + methotrexate As prescribed
2: Placebo Comparator	Drug: Placebo iv every 2 weeks for 12 weeks Drug: NSAIDs + methotrexate As prescribed

Eligibility

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

Criteria

Inclusion Criteria:

patients aged 2-17 years of age;
systemic JIA with >= 6 months persistent activity;
presence of active disease (>=5 active joints, or >=2 active joints + fever + steroids);
inadequate clinical response to NSAIDs and corticosteroids due to toxicity or lack of efficacy.

Exclusion Criteria:

wheelchair or bed-ridden;
any other autoimmune, rheumatic disease or overlap syndrome other than sJIA;
intravenous long-acting corticosteroids or intra-articular corticosteroids within 4 weeks of baseline, or throughout study;
DMARDs (other than methotrexate);
previous treatment with tocilizumab.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00642460

Contacts

Contact: Please reference Study ID Number: WA18221	973-235-5000
Contact: or	800-526-6367 (FOR US ONLY)

Show 58 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WA18221, 2007-000872-18
Study First Received:	March 19, 2008
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00642460 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Arthritis, Juvenile Rheumatoid
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Folic Acid Antagonists

Immunosuppressive Agents
Folic Acid
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases
Methotrexate

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Immune System Diseases
Joint Diseases
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009