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.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: September 2, 2010
Last updated: October 7, 2013
Last verified: October 2013

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:

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


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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01195272

United Kingdom
Liverpool, United Kingdom, L9 7AL
Sponsors and Collaborators
Hoffmann-La Roche
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: October 7, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
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