A Study of Tocilizumab in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01187563
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : October 13, 2011
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
This is an open-label, uncontrolled, observational study in patients with rheumatoid arthritis (RA) who are receiving tocilizumab concomitantly with methotrexate as part of their standard of care.

Condition or disease
Rheumatoid Arthritis

Detailed Description:
This single arm, open label study evaluates the safety and pharmacodynamic profile of tocilizumab in RA patients. Participating patients are among those for whom tocilizumab is indicated and who are scheduled to receive tocilizumab as part of their normal care, in full compliance with the FDA-approved prescribing information. Study assessments consist of clinical evaluations and laboratory tests conducted in conjunction with the first three monthly intravenous infusions of tocilizumab. These assessments are designed to provide a better understanding of the pharmacodynamic effects and mechanistic actions of tocilizumab and help guide the clinical development of other therapeutic agents for RA. A total of 15 patients are expected to participate for approximately 10 weeks.

Study Type : Observational
Actual Enrollment : 16 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase 4, Open-label, Repeat-Dose Study of the Safety and Pharmacodynamic Profile of Tocilizumab and Concomitant Methotrexate in Patients With Rheumatoid Arthritis
Study Start Date : August 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Tocilizumab
U.S. FDA Resources

Primary Outcome Measures :
  1. Safety (clinical and laboratory parameters) [ Time Frame: Throughout the study until week 10 ]
    Proportion of patients with neutropenia, elevated transaminase, and/or decreased platelet count

Secondary Outcome Measures :
  1. Treatment emergent adverse events [ Time Frame: Throughout the study until week 10 ]
    Post-baseline changes in vital signs, and hematological and biochemical parameters

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult rheumatoid arthritis patients with indication for treatment with tocilizumab.

Inclusion Criteria:

  • ≥ 18 years of age
  • Moderately to severely active rheumatoid arthritis
  • Inadequate response to previous treatment with an anti-TNF agent
  • Receiving methotrexate for at least 12 wks before study

Exclusion Criteria:

  • Previous treatment with tocilizumab
  • Previous treatment with other IL-6 receptor inhibitors
  • Treatment with corticosteroids (oral prednisone >10 mg/day or equivalent) within 4 wks
  • Conditions noted in the tocilizumab prescribing information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01187563

United States, Massachusetts
Worcester, Massachusetts, United States
United States, Pennsylvania
Duncansville, Pennsylvania, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01187563     History of Changes
Other Study ID Numbers: 0000-RA-1008
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: October 13, 2011
Last Verified: October 2011

Keywords provided by Regeneron Pharmaceuticals:
Rheumatoid arthritis, tocilizumab

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