Clinical Trials Register

Summary
EudraCT Number:	2012-004089-16
Sponsor's Protocol Code Number:	1541-128
National Competent Authority:	Austria - BASG
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-03-06
Trial 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

Austria - BASG

A.2

EudraCT number

2012-004089-16

A.3

Full title of the trial

The effect of the interleukin-1 receptor antagonist Anakinra in patients with osteoarthritis of the hand:
The AHOA (Anakinra in hand osteoarthritis) pilot study

Interleukin-1 Receptor-Blockade mit Anakinra zur
Therapie der Fingerpolyarthrose
Eine randomisierte, doppelblinde, Placebo-kontrollierte Studie

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Blocking the inflammation-factor IL-1 as treatment for degenerative joint disease of the hands

Blockade des Entzündungsbotenstoffes IL-1 als Therapie bei Knorpelverschleißerkrankung der Fingergelenke

A.3.2

Name or abbreviated title of the trial where available

The AHOA (Anakinra in hand osteoarthritis) pilot study

Anakinra bei Fingerpolyarthrose

A.4.1

Sponsor's protocol code number

1541-128

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie, Medizinische Universität Wien
B.1.3.4	Country	Austria
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Swedish Orphan Biovitrum GmbH
B.4.2	Country	Sweden
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Universitätsklinik für Innere Medizin III, Klinische Abteilung für Rheumatologie, Medizinische Universität Wien
B.5.2	Functional name of contact point	Clinical Trials Information
B.5.3	Address:
B.5.3.1	Street Address	Waehringer Guertel 18-20
B.5.3.2	Town/ city	Wien
B.5.3.3	Post code	1090
B.5.3.4	Country	Austria
B.5.4	Telephone number	+431404004301

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	Kineret
D.2.1.1.2	Name of the Marketing Authorisation holder	Swedish Orphan Biovitrum International AB
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	Anakinra
D.3.2	Product code	not applicable
D.3.4	Pharmaceutical form	Injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraarticular use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ANAKINRA
D.3.9.1	CAS number	143090-92-0
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	na
D.3.9.4	EV Substance Code	SUB05500MIG
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	100
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)	No
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	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
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	Yes
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	Injection
D.8.4	Route of administration of the placebo	Intraarticular use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

osteoarthritis of the hand

Fingerpolyarthrose

E.1.1.1

Medical condition in easily understood language

"degenerative" joint disease of finger joints

Knorpelverschleisserkrankung der Fingergelenke

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Clinical trials have now generated optimism for anti-IL-1ß therapy as a new strategy in OA treatment. Nevertheless, there is an absolute lack in scientific evidence for the efficacy of IL-1beta inhibition in symptomatic non-erosive hand OA, thus, we aim to investigate the efficacy of a treatment with Anakinra 100 mg i.a. every four weeks during 24 weeks versus placebo as a therapeutic intervention in non-erosive symptomatic IPJ OA.

Ziel der Studie ist es, die Wirkung des Medikaments „Anakinra“ bei Patienten mit schmerzhafter (symptomatischer) Fingerpolyarthrose zu untersuchen. Die Substanz führt zur Blockade des Entzündungsbotenstoffes IL-1. Die Inaktivierung von IL-1 führt zur Schmerzlinderung und in weiterer Folge zur Verbesserung der Gelenkfunktion. Eine gelenkschützende Wirkung wäre zudem denkbar. Es soll nun an insgesamt 30 Patienten untersucht werden, ob eine Verbesserung der klinischen Symptome bei Patienten Fingerpolyarthrose erzielt werden kann.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

A subject will be eligible for study participation if he/she meets the following criteria:
• Males and females > 18 years of age. All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study.
• Persistent or transient pain/aching at more than 3 days a week in at least one DIP and/or PIP joint with or without bony swelling
• Hand X-ray showing alterations typical for OA
• If NSAIDs are used to treat finger joint pain dosage must be stable for at least 4 weeks
• Able and willing to give written informed consent and to comply with the requirements of the study protocol.

In diese Studie können Patientinnen und Patienten eingeschlossen werden, welche an schmerzhafter (symptomatischer) Fingerpolyarthrose leiden

E.4

Principal exclusion criteria

A subject will be excluded from the study if he/she meets any of the following criteria:
• Prior treatment with any investigational agent within 30 days, or five half lives of the product, whichever is longer.
• Patients suffering from chronic inflammatory rheumatic disease (e.g. rheumatoid arthritis or positive rheumatoid factor or positive anti-CCP antibodies, seronegative spondylarthropathy, haemochromatosis, gout, chondrocalcinosis or other auto-immune diseases
• Stable dosage for at least 3 months with chondroitin sulfate, glucosamine, biphosphonate, tetracyclines and estrogens is allowed.
• Prior use of any immunomodulating drug with possible effects on pro-inflammatory cytokine metabolism within 90 days a.o. corticosteroids, methotrexate, sulfasalazine, leflunomide, d-penicillamin, anti-malarials, cytotoxic drugs, TNF blocking agents
• If the patient is of child-bearing age, she must use effective means of contraception during the study.
• Use of anticoagulants (cumarins or low-molecular-weight-heparins)
• Subjects with hand OA showing or having suffered from transient inflammatory attacks of the IPJs characteristic for what has been termed ‘inflammatory’ or ‘erosive’ hand OA.
• Patient who has a known blood coagulation disorder
• History of cancer or lymphoproliferative disease
• Comorbidities: uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (NYHA III, IV), recent stroke (within three months), uncontrolled hypertension (defined as screening systolic blood pressure > 160 mmHg or screening diastolic blood pressure > 100 mmHg), severe pulmonary disease requiring hospitalization or supplemental oxygen
• Impaired renal function (CL Cr <30 ml/minute)
• Persistent or recurrent infections or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
• Female subjects who are breast-feeding.
• History of clinically significant drug or alcohol abuse in the last year.
• Medical history of systemic lupus erythematosus or other connective tissue disease, RA, reactive arthritis, psoriasis
• Reasonable expectation that the subject will not be able to satisfactorily complete the study. History of or current psychiatric illness, alcohol or drug abuse that would interfere with the subject’s ability to comply with protocol requirements or give informed consent.

Patienten mit chronisch entzündlichen Erkrankungen (beispielsweise chronische Polyarthritis, Psoriasisarthritis, aber auch erosive oder aktivierte Fingerpolyarthrose) werden nicht in die Studie eingeschlossen. Die Einnahme entzündungsmodulierender Medikamente (wie Kortison, Methotrexat, usw.) schließt eine Aufnahme in diese Studie ebenfalls aus

E.5 End points

E.5.1

Primary end point(s)

improvement of joint pain

Verbesserung des Gelenkschmerzes

E.5.1.1

Timepoint(s) of evaluation of this end point

every visit (Week-2,0,2,4,8,12,16,20,24,52)

jede Visite (Woche-2,0,2,4,8,12,16,20,24,52)

E.5.2

Secondary end point(s)

structure modifying effects as determined by MRI scan
improvement of specific and generic physical function and joint stiffness
improvement of patient global assessment

Strukturmodifikation nachgewiesen durch MRT
Verbesserung der Gelenkfunktion
Verbesserung des patient global assessment

E.5.2.1

Timepoint(s) of evaluation of this end point

structure modifying effects as determined by MRI scan: week-2 and week 52
improvement of specific and generic physical function and joint stiffness: Week-2,0,2,4,8,12,16,20,24,52
improvement of patient global assessment: Week-2,0,2,4,8,12,16,20,24,52

Strukturmodifikation nachgewiesen durch MRT: Woche -2 und 52
Verbesserung der Gelenkfunktion: Woche-2,0,2,4,8,12,16,20,24,52
Verbesserung des patient global assessment: Woche-2,0,2,4,8,12,16,20,24,52

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

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

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

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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)

E.8.2.2

Placebo

Yes

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the 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

E.8.6.2

Trial being conducted completely outside of the EEA

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

LVLS

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

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Keine

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

2013-04-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-04

P. End of Trial
P.	End of Trial Status	Ongoing

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