A Study of Tocilizumab in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01187563
First received: August 23, 2010
Last updated: October 12, 2011
Last verified: October 2011
  Purpose

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
Rheumatoid Arthritis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

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


Secondary Outcome Measures:
  • Treatment emergent adverse events [ Time Frame: Throughout the study until week 10 ] [ Designated as safety issue: Yes ]
    Post-baseline changes in vital signs, and hematological and biochemical parameters


Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 16
Study Start Date: August 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult rheumatoid arthritis patients with indication for treatment with tocilizumab.

Criteria

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
  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: NCT01187563

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

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01187563     History of Changes
Other Study ID Numbers: 0000-RA-1008
Study First Received: August 23, 2010
Last Updated: October 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Regeneron Pharmaceuticals:
Rheumatoid arthritis, tocilizumab

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

ClinicalTrials.gov processed this record on October 23, 2014