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: October 7, 2013
Last verified: October 2013

September 2, 2010
October 7, 2013
August 2010
March 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01195272 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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.
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: tocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 52 weeks
Experimental: Single Arm
Intervention: Drug: tocilizumab [RoActemra/Actemra]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01195272
ML25243, 2010-018331-18
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP