Phase 4 Completed N=21 Treatment

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.

Source: ClinicalTrials.gov NCT01195272 ↗

Enrolled (actual)

Serious AEs

19.1%

Results posted

Nov 2014

Primary outcomePrimary: Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis — 8.95; 7.36; 8.45; 12.43 percentage of cells staining positive — p=0.308

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis	8.95; 7.36; 8.45; 12.43; 53.97; 50.32	0.308
PRIMARY Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)	5.46; 4.18; 4.64; 6.34; 27.00; 28.35	0.288
PRIMARY Mean Fluorescence Intensity of CD11b on Neutrophil Surface	286.40; 275.33; 240.93	0.39
PRIMARY Mean Fluorescence Intensity of CD18 on Neutrophil Surface	20.33; 20.47; 22.47	0.48
PRIMARY Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface	20.56; 23.40; 19.93	0.22
PRIMARY Mean Fluorescence Intensity of CD63 on Neutrophil Surface	31.00; 26.34; 30.28	0.22
PRIMARY Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface	2.72; 3.69; 4.42	0.05
PRIMARY Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface	3.49; 3.55; 3.75	0.48
PRIMARY Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation	8671; 9971; 32361; 10573	0.313
PRIMARY Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation	141039; 145304; 157028; 116968	0.467
PRIMARY Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake	96.59; 97.47; 97.53; 97.25	0.169
PRIMARY Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation	99.21; 99.20; 99.91; 99.92	0.496
SECONDARY Disease Activity Score Based on 28-Joint Count (DAS28)	5.67; 6.15; 4.90; 4.31; 3.83; 3.81	—
SECONDARY Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments	100; 0; 94; 6; 92; 8	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01195272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.