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A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01195272
First received: September 2, 2010
Last updated: May 23, 2013
Last verified: May 2013
History of Changes
  Purpose

This open-label, single arm study will assess the effect of RoActemra/Actemra (tocilizumab) on neutrophils and monitor safety and benefit-risk of RoActemra/Actemra treatment in patients with active rheumatoid arthritis who have an inadequate response to current biologic or non-biologic disease-modifying antirheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg intravenously every 4 weeks, either as monotherapy or in combination with their current non-biologic DMARD. Anticipated time on study treatment is 52 weeks.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: tocilizumab [RoActemra/Actemra]
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy

Resource links provided by NLM:

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

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Effects on neutrophil function and survival: Neutrophil morphology by light microscopy, function by ex vivo surface molecule expression using flow cytometry, survival by ex vivo evaluation of apoptosis utilizing a combination of techniques [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and benefit-risk assessments, according to Summary of Product Characteristics (SPC) and improvements in disease activity score (DAS28) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: August 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 52 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe active rheumatoid arthritis of >/= 6 months duration
  • DAS28 >/= 3.2 at screening and baseline
  • Inadequate response to biologic or non-biologic DMARDs
  • Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug
  • If continuing on a non-biologic DMARD, dose should be stable for at least 8 weeks
  • Oral corticosteroids must have been at stable dose for at least 25 out of 28 days prior to baseline

Exclusion Criteria:

  • Major surgery (including joint surgery) within 8 weeks prior to screening or not recovered from prior surgery
  • Rheumatic autoimmune disease other then RA
  • Functional class IV as defined by the American College of Rheumatology (ACR) classification
  • Prior history of or current inflammatory joint disease other than RA
  • Previous treatment with any cell-depleting therapies
  • Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline
  • Active infection or history of recurrent infection
  • Positive for HIV or hepatitis B or C
  • History of or current primary or secondary immunodeficiency
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195272

Locations
United Kingdom
Liverpool, United Kingdom, L9 7AL
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: NCT01195272     History of Changes
Other Study ID Numbers: ML25243, 2010-018331-18
Study First Received: September 2, 2010
Last Updated: May 23, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013