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.

Roche

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: tocilizumab [RoActemra/Actemra]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01195272

ML25243

2010-018331-18

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Single Arm

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]