Clinical Trials Register

Summary
EudraCT Number:	2010-024172-26
Sponsor's Protocol Code Number:	CACZ885H2358
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-08-09
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Poland - Office for Medicinal Products

A.2

EudraCT number

2010-024172-26

A.3

Full title of the trial

A randomized, double-blind, double-dummy, active controlled study of ACZ885 (canakinumab) on the treatment and prevention of gout flares in patients with frequent flares, for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective

A.4.1

Sponsor's protocol code number

CACZ885H2358

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Novartis Pharma Services AG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	ILARIS
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Canakinumab
D.3.2	Product code	ACZ885
D.3.4	Pharmaceutical form	Powder for solution for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CANAKINUMAB
D.3.9.1	CAS number	914613-48-2
D.3.9.2	Current sponsor code	ACZ885
D.3.9.3	Other descriptive name	Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	150
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	Yes
D.3.11.13.1	Other medicinal product type	Recombinant human monoclonal antibody
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Triamcinolone acetonide
D.3.4	Pharmaceutical form	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intramuscular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	76-25-5
D.3.9.3	Other descriptive name	TRIAMCINOLONE ACETONIDE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	40
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	Information not present in EudraCT
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	Information not present in EudraCT
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Information not present in EudraCT
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for solution for injection
D.8.4	Route of administration of the placebo	Subcutaneous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Emulsion for injection
D.8.4	Route of administration of the placebo	Intramuscular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

treatment and prevention of gout flares in patients with frequent flares for whom NSAIDs and/ or colchicine are contraindicated, not tolerated or ineffective

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	17.0
E.1.2	Level	PT
E.1.2	Classification code	10018627
E.1.2	Term	Gout
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The two co-primary objectives of this study are:
• To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient’s assessment of gout pain intensity in the most affected joint at 72 hours post-dose (on a 0-100mm VAS)
• To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
Both co-primary objectives have to be met.

E.2.2

Secondary objectives of the trial

The secondary objectives of this study are:
• To evaluate the percentage of patients with at least 1 new gout flare during 12 weeks
• To evaluate the efficacy of canakinumab 150 mg s.c. compared to triamcinolone acetonide 40 mg i.m. with respect to the treatment of signs and symptoms of baseline gout flare, defined as:
- Patient’s assessment of gout pain intensity in the most affected joint (on a 0-100 mm VAS) over time
- Patient’s assessment of gout pain intensity in the most affected joint (Likert scale)
over time
- Patient’s global assessment of response to treatment (Likert scale) over time
- Physician’s assessment of tenderness, swelling and erythema over time
- Physician’s assessment of range of motion of the most affected joint (Likert scale)
over time
- Physician’s global assessment of response to treatment (Likert scale) over time
• To evaluate the time to 50% reduction of baseline pain intensity in the most affected joint
[...]
please refer to the protocol

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Signed written informed consent before any study procedure is performed.
2. Male or female patients aged ≥ 18 - ≤ 85 years
3. Meeting the ACR 1977 preliminary criteria for the classification of acute arthritis of
primary gout.
4. Onset of current acute gout flare within 5 days prior to randomization.
5. Patient’s assessment of baseline pain intensity ≥ 50 mm on the 0-100 mm VAS.
6. History of ≥ 3 gout flares within the 12 months prior to randomization (based on patient history, referral letter and/ or patient interview).
7. Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for:
a. NSAIDs defined as (based on medical history, referral letter, and/ or patient
interview)and/or
b. colchicine (based on medical history, referral letter, and/ or patient interview)
8. If on urate lowering therapy (e.g. allopurinol, febuxostat, pegloticase, probenecid) and/or on prophylactic low-dose colchicine, stable dose and schedule with no changes in therapy for 2 weeks prior to randomization and expected to remain on a stable regimen during study participation.
9. BMI ≤ 45 kg/m2.

E.4

Principal exclusion criteria

Patients fulfilling any of the following criteria are not eligible for inclusion in this study:
1. Use of the following therapies:
a. Corticosteroids:
• A dose of ≥ 10mg of prednisolone or equivalent within 24 hours before screening
for any indication.
• Chronic corticosteroid treatment (defined as a prednisolone dose of ≥ 5 mg/ day
or equivalent taken for more than 28 days)
• Intra-articular corticosteroids into the most affected joint within 14 days before
screening.
• Intra-muscular corticosteroids for any indication within 14 days before screening.
b. Narcotics (opiates and tramadol) within 24 hours before screening
c. NSAIDs (including Cox-2 inhibitors) and other pain medication as defined below:
• Any acetaminophen (paracetamol) within 4 hours before screening or > 1 g within 24 hours before screening
• Ibuprofen: any ibuprofen within 4 hours before screening (Day 1) or > 400 mg within 8 hours before screening (i.e. 0-400 mg ibuprofen allowed between 4-8 hours before screening)
• Aspirin: any aspirin within 4 hours before screening or> 600 mg within 24 hours
before screening
• Over-the-counter analgesic aspirin-based or paracetamol-based combination
medications: any number of tablets within 4 hours before screening or > 2 tablets within 24 hours before screening
• Diclofenac: any diclofenac within 8 hours before screening or > 50 mg within 24 hours before screening
• Naproxen: any naproxen within 12 hours before screening or > 500 mg within 24 hours before screening
• Cox-2 inhibitors within 48 hours before screening
• Other NSAIDs within 24 hours before screening
d. Colchicine: > 1.2 mg within 24 hours before screening
e. Topical ice/ cold packs within 6 hours before screening
f. Chronic opiate treatment within 14 days before screening
g. Any IL-1 blocker, TNF inhibitor, other biologic or investigational drug within 30 days or 5 half-lives before randomization, whichever is longer, or as instructed by
local regulations.
h. Herbal therapy treatment taken orally for gout indication one month before screening.
Topical herbal therapy packs 6 hours before screening.
i. Acupuncture treatment for gout indication one month before screening
2. Hemodialysis
3. Live vaccinations within 3 months prior to randomization.
4. Donation or loss of 400 mL or more of blood in the 8 weeks prior to randomization.
5. Requirement for administration of antibiotics against latent tuberculosis (TB), e.g.,
isoniazide (courses of antibiotic therapy started prior to entering the study should not be prematurely terminated to allow inclusion into the study).
6. Refractory heart failure (Stage D). Patients for whom electrical device therapy is indicated
(e.g. history of cardiac arrest, ventricular fibrillation, or hemodynamically destabilizing
ventricular tachycardia, with LVEF <35%) are excluded from the study.
7. Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
8. Secondary gout chemotherapy induced gout, lead induced gout and transplant gout.
9. Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute
inflammatory arthritis.
10. History of hypersensitivity to the study drugs or to molecules with similar structures, or
contraindication to intramuscular injection (e.g. patients on anticoagulants,
thrombocytopenia, known hemostasis disease).
11. Presence of idiopathic thrombocytopenic purpura.
12. Known presence or suspicion of Human Immunodeficiency Virus (HIV) infection,
Hepatitis B and Hepatitis C infections (based on history and/or clinical findings) or any
active or recurrent bacterial, fungal or viral infection at the time of enrollment, where an
IL-1 blocker might have an impact on an underlying severe, immunocompromised disease
state
13. One of the risk factors for TB such as but not limited or exclusive to:
a. History of any of the following: residence in a congregate setting (e.g. jail or prison,
homeless shelter, or chronic care facility), substance abuse (e.g. injection or noninjection);
health-care workers with unprotected exposure to patients who are at high
risk of TB or patients with TB disease before the identification and correct airborne
precautions of the patient, or
b. Close contact (i.e. share the same air space in a household or other enclosed
environment for a prolonged period (days or weeks, not minutes or hours)) with a
person with active pulmonary TB disease within the last 12 months.
14. History of ongoing, chronic or recurrent infectious disease or evidence of tuberculosis
infection determined as defined by local guidelines/ local medical practice (see also
Section 6.2.2). If presence of tuberculosis is established then treatment (according to local
guidelines) must have been completed prior to randomization.
[...]
please refer to the protocol

E.5 End points

E.5.1

Primary end point(s)

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

immunogenicity

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.3	Elderly (>=65 years)	Yes
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	20
F.4.2	For a multinational trial
F.4.2.1	In the EEA	15
F.4.2.2	In the whole clinical trial	220

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-08-08

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-03-29

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-05-19

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