Rheumatoid ArthritisPhase 4NCT01195272

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 Phase 4 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: tocilizumab [RoActemra/Actemra]
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited Kingdom
Study dates: Aug 2010to Mar 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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Biologic DMARDs must be withdrawn (approximately 5 half-lives for the agent) before first dose of study drug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

Who cannot join

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

Show all 9Show fewer

Active infection or history of recurrent infection
Positive for HIV or hepatitis B or C
History of or current primary or secondary immunodeficiency

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
Liverpool, L9 7AL

Other trials in United Kingdom

About this study

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

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.

Conditions: Rheumatoid Arthritis
Being tested: tocilizumab [RoActemra/Actemra]
Medical subject headings: Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tocilizumab [RoActemra/Actemra]Drug
8 mg/kg iv every 4 weeks, 52 weeks

Study groups in NCT01195272
Study group	Role	What they receive
Single Arm	Experimental	Not described Receives: Drug: tocilizumab [RoActemra/Actemra]

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis
Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of fluorescein isothiocyanate (FITC)-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hours (hrs) and 20 hrs stimulated and control samples were analyzed for levels of apoptosis.
Measured: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)
Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of FITC-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hrs and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. GM-CSF is an agent that delays apoptosis. Percentage of cells that stained positive for Annexin V binding in the presence or absence of GM-CSF (GM-CSF delayed or constitutive) were determined by flow cytometry.
Measured: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)
Mean Fluorescence Intensity of CD11b on Neutrophil Surface
Neutrophils were incubated with labeled antibodies against CD11b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.
Measured: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Mean Fluorescence Intensity of CD18 on Neutrophil Surface
Neutrophils were incubated with labeled antibodies against CD18. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.
Measured: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface
Neutrophils were incubated with labeled antibody against CD62L (L selectin). Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion of neutrophils to vessel walls.
Measured: Visits 2, 3 and 5 (Baseline and Weeks 4 and 12)
Mean Fluorescence Intensity of CD63 on Neutrophil Surface
Neutrophils were incubated with labeled antibody against CD63b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater azurophilic degranulation, an indicator of greater microbe killing.
Measured: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface
Neutrophils were incubated with labeled antibody against IL-6R. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater density of membrane bound IL-6 receptor.
Measured: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface
Neutrophils were incubated with labeled antibody against mTNF. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates to a greater density of membrane bound TNF.
Measured: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation
Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). fMLP stimulation is mediated through the fMLP receptor on the cell surface. The fMLP response is only observed in primed neutrophils and response is a measure of in vivo priming. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.
Measured: Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)
Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation
Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). PMA is a receptor-independent stimulator of the respiratory burst and the PMA response measures the total capacity of neutrophils to generate reactive oxidants. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.
Measured: Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)
Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake
1. aureus were heat killed then labeled with PI and opsonized with AB serum (SAPI). S. aureus was then incubated with the neutrophils for 30 minutes at 37 degrees Celsius. The neutrophils were washed, then the percentage of cells positive for the labeled S. aureus (that is, phagocytosed) was calculated via flow cytometry. A higher percentage represented more active phagocytosis.
Measured: Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)
Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation
Phagocytosis can be measured by incubating neutrophils with PI-labeled heat killed S. aureus following incubation for 30 minutes. Neutrophils are co-incubated with DHR, which becomes oxidized by the products of the respiratory burst generated during phagocytosis. Fluorescence can then be measured by flow cytometry.
Measured: Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)

Secondary outcomes (2)

Disease Activity Score Based on 28-Joint Count (DAS28)
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis. The index includes swollen and tender joint counts, acute phase response (erythrocyte sedimentation rate [ESR] or C-reactive protein [CRP]), and general health status. The DAS28, which uses a 28 joint count, is derived from the original DAS, which includes a 44 swollen joint count. The DAS28 scale ranges from 0 to 10, where higher scores represent higher disease activity.
Measured: Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52
Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments
Benefit:Risk was defined at the participant level. It was considered acceptable if the DAS28 improvement represented at least a moderate European League Against Rheumatism (EULAR) response. The risks were based on the known adverse event (AE) profile of tocilizumab rather than on the actual AEs experienced by each participant
Measured: Weeks 12, 24, and 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Mar 2012

First posted6 Sep 2010 (estimated)
Study startAug 2010
Primary completionMar 2012
Study completionMar 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01195272
Sponsor's protocol ID: ML25243
Other IDs: 2010-018331-18
Status last verified: Nov 2014
First submitted: 2 Sep 2010
Last updated: 13 Nov 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01195272
Acronym / sponsor ID: ML25243
Conditions: Rheumatoid Arthritis
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 6 Sep 2010 (estimated)
Results: Posted 13 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Experimental	Drug: tocilizumab [RoActemra/Actemra]

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
tocilizumab [RoActemra/Actemra]8 mg/kg iv every 4 weeks, 52 weeks	Drug	Single Arm

Primary outcome

Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis
Time frame: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)
Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of fluorescein isothiocyanate (FITC)-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hours (hrs) and 20 hrs stimulated and control samples were analyzed for levels of apoptosis.
Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)
Time frame: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)
Aging neutrophils translocate phosphatidylserine from the inner leaflet of the plasma membrane to the outer leaflet during the early stages of apoptosis. This translocation can be measured due to the affinity of FITC-labeled annexin V to bind exposed phosphatidylserine. Cells that stain positive to Annexin V binding are apoptotic. At 4 hrs and 20 hrs stimulated and control samples were analyzed for levels of apoptosis. GM-CSF is an agent that delays apoptosis. Percentage of cells that stained positive for Annexin V binding in the presence or absence of GM-CSF (GM-CSF delayed or constitutive) were determined by flow cytometry.
Mean Fluorescence Intensity of CD11b on Neutrophil Surface
Time frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Neutrophils were incubated with labeled antibodies against CD11b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.
Mean Fluorescence Intensity of CD18 on Neutrophil Surface
Time frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Neutrophils were incubated with labeled antibodies against CD18. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion, migration, and ingestion of complement-opsonized particles.
Mean Fluorescence Intensity of CD62L (L Selectin) on Neutrophil Surface
Time frame: Visits 2, 3 and 5 (Baseline and Weeks 4 and 12)
Neutrophils were incubated with labeled antibody against CD62L (L selectin). Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater adhesion of neutrophils to vessel walls.
Mean Fluorescence Intensity of CD63 on Neutrophil Surface
Time frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Neutrophils were incubated with labeled antibody against CD63b. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater azurophilic degranulation, an indicator of greater microbe killing.
Mean Fluorescence Intensity of Interleukin-6 Receptor (Il-6R) on Neutrophil Surface
Time frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Neutrophils were incubated with labeled antibody against IL-6R. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates with greater density of membrane bound IL-6 receptor.
Mean Fluorescence Intensity of Membrane Bound Tumor Necrosis Factor Alpha (mTNFα) on Neutrophil Surface
Time frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12)
Neutrophils were incubated with labeled antibody against mTNF. Flow cytometry was used to determine the mean fluorescence intensity. Greater fluorescence correlates to a greater density of membrane bound TNF.
Mean Chemiluminescence (Area Under the Concentration-time Curve [AUC]) of Neutrophil Reactive Species Production Using Formyl-Methionyl-Leucyl-Phenylalanine (fMLP) Stimulation
Time frame: Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)
Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). fMLP stimulation is mediated through the fMLP receptor on the cell surface. The fMLP response is only observed in primed neutrophils and response is a measure of in vivo priming. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.
Mean Chemiluminescence (AUC) of Neutrophil Reactive Species Production Using Phorbol 12-Myristate 13-Acetate (PMA) Stimulation
Time frame: Visit 2, 3, 5, and 8 (Baseline and predose at Weeks 4, 12 and 24)
Using luminol as a substrate for reactive oxidants, a chemical reaction is produced resulting in photon emission (chemiluminescence). PMA is a receptor-independent stimulator of the respiratory burst and the PMA response measures the total capacity of neutrophils to generate reactive oxidants. Measurements of reactive oxygen species are calculated as total chemiluminescence or the AUC.
Percentage of Neutrophils Positive for Propidium Iodide (PI)-Labeled Staphylococcus Aureus (S. Aureus) Uptake
Time frame: Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)
S. aureus were heat killed then labeled with PI and opsonized with AB serum (SAPI). S. aureus was then incubated with the neutrophils for 30 minutes at 37 degrees Celsius. The neutrophils were washed, then the percentage of cells positive for the labeled S. aureus (that is, phagocytosed) was calculated via flow cytometry. A higher percentage represented more active phagocytosis.
Percentage of Neutrophils Positive for Dihydrorhodamine-123 (DHR) Oxidation
Time frame: Visit 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)
Phagocytosis can be measured by incubating neutrophils with PI-labeled heat killed S. aureus following incubation for 30 minutes. Neutrophils are co-incubated with DHR, which becomes oxidized by the products of the respiratory burst generated during phagocytosis. Fluorescence can then be measured by flow cytometry.

2 secondary outcomes

Disease Activity Score Based on 28-Joint Count (DAS28)
Time frame: Screening, Baseline, and Weeks 4, 8, 12, 16, 20, 24, 36, 48, and 52
Percentage of Participants With Acceptable and Not Acceptable Benefit-Risk Assessments
Time frame: Weeks 12, 24, and 36

Results and safety

Results posted to the registry on 13 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tocilizumab 8 Milligrams Per Kilogram (mg/kg)	21	17

Primary outcome: Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis

Time frame: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24). Mean (Standard Deviation). Unit: percentage of cells staining positive

Measure	Tocilizumab 8 mg/kg n = 19
Visit 2, 4 hrs (n=19)	8.95 (5.46)
Visit 3, 4 hrs (n=19)	7.36 (4.18)
Visit 5, 4 hrs (n=19)	8.45 (4.64)
Visit 8, 4 hrs (n=15)	12.43 (6.34)
Visit 2, 20 hrs (n=19)	53.97 (8.97)
Visit 3, 20 hrs (n=19)	50.32 (10.64)
Visit 5, 20 hrs (n=19)	50.50 (15.51)
Visit 8, 20 hrs (n=15)	48.24 (10.37)

Tocilizumab 8 mg/kg: p = 0.308, t-test, 2 sided
Tocilizumab 8 mg/kg: p = 0.415, t-test, 2 sided
Tocilizumab 8 mg/kg: p = 0.335, t-test, 2 sided

Population analysed: Intent-to-treat (ITT) Population: all participants in the Safety Population who provided follow-up data for neutrophils or at least 1 efficacy variable. n (number) equals (=) number of participants analyzed for the specified parameter at a given visit.

Primary outcome: Mean Percentage of Cells Staining Positive for Annexin V Binding With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Time frame: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24). Mean (Standard Deviation). Unit: percentage of cells staining positive

Measure	Tocilizumab 8 mg/kg n = 19
Visit 2, 4 hrs (n=19)	5.46 (6.73)
Visit 3, 4 hrs (n=19)	4.18 (7.13)
Visit 5, 4 hrs (n=19)	4.64 (3.18)
Visit 8, 4 hrs (n=15)	6.34 (2.58)
Visit 2, 20 hrs (n=19)	27.00 (11.16)
Visit 3, 20 hrs (n=19)	28.35 (10.95)
Visit 5, 20 hrs (n=19)	29.68 (14.78)
Visit 8, 20 hrs (n=15)	27.79 (12.01)

Tocilizumab 8 mg/kg: p = 0.288, t-test, 2 sided
Tocilizumab 8 mg/kg: p = 0.318, t-test, 2 sided
Tocilizumab 8 mg/kg: p = 0.400, t-test, 2 sided

Population analysed: ITT Population; n=number of participants analyzed for the specified parameter at a given visit.

Primary outcome: Mean Fluorescence Intensity of CD11b on Neutrophil Surface

Time frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12). Mean (Standard Deviation). Unit: fluorescence intensity unit

Measure	Tocilizumab 8 mg/kg n = 19
Visit 2 (n=19)	286.40 (105.86)
Visit 3 (n=17)	275.33 (127.37)
Visit 5 (n=16)	240.93 (77.50)

Tocilizumab 8 mg/kg: p = 0.39, ANOVA
Tocilizumab 8 mg/kg: p = 0.08, ANOVA
Tocilizumab 8 mg/kg: p = 0.18, ANOVA

Population analysed: ITT Population; n=number of participants analyzed for the specified parameter at a given visit.

Primary outcome: Mean Fluorescence Intensity of CD18 on Neutrophil Surface

Time frame: Visits 2, 3, and 5 (Baseline and Weeks 4 and 12). Mean (Standard Deviation). Unit: fluorescence intensity unit

Measure	Tocilizumab 8 mg/kg n = 19
Visit 2 (n=19)	20.33 (8.30)
Visit 3 (n=17)	20.47 (12.31)
Visit 5 (n=16)	22.47 (15.42)

Tocilizumab 8 mg/kg: p = 0.48, ANOVA
Tocilizumab 8 mg/kg: p = 0.30, ANOVA
Tocilizumab 8 mg/kg: p = 0.34, ANOVA

Population analysed: ITT Population; n=number of participants analyzed at each visit

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded from the date of Screening until the End of Study which was the follow up visit after 48 Weeks of extension treatment period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tocilizumab 8 mg/kg	4 of 21 (19%)	21 of 21 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing tocilizumab [RoActemra/Actemra] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Percentage of Cells Staining Positive for Annexin V Binding in Apoptosis (time frame: Visits 2, 3, 5, and 8 (Baseline and Weeks 4, 12 and 24)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01195272.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2014.