Clinical Trials Register

Summary
EudraCT Number:	2012-002798-80
Sponsor's Protocol Code Number:	IM101-332
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-09-25
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2012-002798-80

A.3

Full title of the trial

A Phase 3 Randomized Placebo Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults with Active Psoriatic Arthritis

A.3.1

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

Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Psoriatic Arthritis

A.3.2

Name or abbreviated title of the trial where available

ASTRAEA - Active PSoriaTic ARthritis RAndomizEd TriAl

A.4.1

Sponsor's protocol code number

IM101-332

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT01860976

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	Bristol-Myers Squibb International Corporation
B.1.3.4	Country	Belgium
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	Bristol-Myers Squibb International Corporation
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Bristol-Myers Squibb International Corporation
B.5.2	Functional name of contact point	EU Study Start-Up Unit
B.5.3	Address:
B.5.3.1	Street Address	Parc de l'Alliance - Avenue de Finlande, 4
B.5.3.2	Town/ city	Braine-l'Alleud
B.5.3.3	Post code	1420
B.5.3.4	Country	Belgium
B.5.6	E-mail	clinical.trials@bms.com

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	No
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	Abatacept
D.3.2	Product code	BMS-188667
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
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	ABATACEPT
D.3.9.1	CAS number	332348-12-6
D.3.9.2	Current sponsor code	BMS-188667
D.3.9.4	EV Substance Code	SUB20635
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	125
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	Yes
D.3.11.13.1	Other medicinal product type	fusion protein

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	Solution for injection in pre-filled syringe
D.8.4	Route of administration of the placebo	Subcutaneous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Active Psoriatic Arthritis

E.1.1.1

Medical condition in easily understood language

Active Psoriatic Arthritis

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis
E.1.2	System Organ Class	100000004859

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To compare the efficacy of abatacept to placebo as assessed by the ACR20 response at Day 169.

E.2.2

Secondary objectives of the trial

● To compare the efficacy of abatacept to placebo as assessed by the Health Assessment Questionnaire (HAQ) response at Day 169
● To compare the efficacy of abatacept to placebo in the subset of subjects who have never been exposed to TNFi therapy, as assessed by the ACR20 response at Day 169
● To compare the efficacy of abatacept to placebo in the subset of subjects who have previously taken TNFi therapy, as assessed by the ACR20 response at Day 169
● To compare the efficacy of abatacept to placebo as assessed by the proportion of subjects who do not show progression of x-rays [using the PsA modified Sharp/van der Heidje score (SHS)] from baseline to Day 169

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

● Intensive Pharmacokinetics/Pharmacodynamics (PK/PD) substudy (refer to main study Protocol sections 5.5.1 and 5.6.3):
Approximately 60 subjects will be enrolled. In addition to the samples drawn on Days 1, 85, and 169 for PK in all subjects, these subjects will also have PK samples drawn on Days 29, 57, 113, and anytime between Days 114 and 120. These subjects will also have samples drawn for flow cytometric T cell phenotyping on Days 1, 29, and 169.

● Skin Biopsy substudy (refer to main study Protocol sections 5.6.4 and 5.8.1):
Approximately 30 subjects will be enrolled. Biopsies will be taken on Day 1 and Day 169, for exploratory biomarker analysis including genome analysis and histology. These samples will be used to generate broad genomic profiling to search for novel pharmacodynamic and efficacy biomarkers related to inflammation, autoimmunity and costimulation-related pathways. Furthermore, these samples will be used to search for genes at baseline that may be predictive of efficacy for abatacept treated subjects. This pharmacogenomic analysis of skin biopsies will be done in countries where feasible based on regulatory requirements.

E.3

Principal inclusion criteria

• Subjects at least 18 years of age who have a diagnosis of PsA by Classification Criteria for Psoriatic Arthritis (CASPAR)
• Subjects have active PsA as shown by a minimum of ≥ 3 swollen joints and ≥ 3 tender joints (66/68 joint counts) at screening and randomization/Day 1 (prior to study drug administration). At least one of the swollen joints must be in the digit of the hand or foot.
• Subjects with at least one confirmed ≥ 2 cm target lesion of plaque psoriasis in a region of the body that can be evaluated.
• Subjects must have had an inadequate response or intolerance to at least one non-biologic disease-modifying anti-rheumatic drug (DMARD).
• Subjects may have been exposed to TNFi therapy. Subjects may have discontinued for any reason (inadequate response, intolerance or other).
• Subjects may enroll on certain concomitant non-biologic DMARDs (methotrexate, leflunomide, sulfasalazine, or hydroxychloroquine) provided the medication has been used for at least 3 months with a stable dose for at least 28 days prior to randomization (Day 1).
• If using oral corticosteroids (≤ 10 mg mg/day prednisone equivalent), dose must be stable ≥14 days prior to randomization (Day 1).
• Subjects may enroll on systemic retinoids (eg, acitretin) provided the medication has been used for at least 3 months with a stable dose for at least 28 days prior to randomization (Day 1).

E.4

Principal exclusion criteria

• Subjects with guttate, pustular, or erythrodermic psoriasis
• Subjects who have had prior exposure to abatacept (CTLA 4Ig)
• Subjects who have been exposed to any investigational drug within 4 weeks or 5 half lives, whichever is longer
• Prior use of apremilast or ustekinumab
• Female subjects who had a breast cancer screening study that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations
• Subjects with a history of cancer within the last 5 years (other than non-melanoma skin cell cancers cured by local resection). Existing non-melanoma skin cell cancers must be removed prior to dosing. Subjects with carcinoma in situ, treated with definitive surgical intervention prior to study enrollment are allowed.
• Subjects with any bacterial infection within the last 60 days prior to screening (enrollment), unless treated and resolved with antibiotics, or any chronic bacterial infection (such as chronic pyelonephritis, osteomyelitis and bronchiectasis).
• Subjects at risk for tuberculosis
• Subjects with herpes zoster that resolved less than 2 months prior to enrollment
• Subjects with evidence of active or latent bacterial, active viral, or serious latent viral infections at the time of enrollment, including subjects with evidence of Immunodeficiency Virus (HIV) infection
• Subjects who are not currently treated with a non-biologic DMARD and have clinical or radiographic evidence of arthritis mutilans (eg, digital telescoping or “pencil-in-cup” radiographic changes)
• Subjects who have taken >2 TNFis
• Subjects who have received TNFi therapy within 8 weeks for adalimumab, etanercept, or certolizumab or within 12 weeks for infliximab or golimumab
• Subjects who have discontinued a non-biologic DMARD or systemic retinoid within four weeks or five half-lives, whichever is longer, prior to randomization (Day 1)
• Use of any of the following within 28 days or five half lives whichever is longer prior to randomization (Day 1): cyclosporine A, oral tacrolimus, mycophenolate mofetil (MMF), hydroxyurea, fumaric acid esters, paclitaxel, 6-thioguanine, 6-mercatopurine, or tofacitinib

E.5 End points

E.5.1

Primary end point(s)

Proportion of ACR20 responders

E.5.1.1

Timepoint(s) of evaluation of this end point

Day 169

E.5.2

Secondary end point(s)

1) HAQ responders
2) ACR20 responders (TNF-naïve)
3) ACR20 responders (TNFi exposed)
4) Non-progressors in total PsA modified SHS
5) PASI50 responders
6) ACR50 responders
7) ACR70 responders
8) Mean change in the SF36 subscales.
9) Immunogenicity
10) Safety

E.5.2.1

Timepoint(s) of evaluation of this end point

1) Day 169
2) Day 169
3) Day 169
4) Day 169
5) Day 169
6) Day 169
7) Day 169
8) Day 169
9) Day 1 to Day 169
10) Day 1 to Day 169

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

Yes

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

• Health Assessment Questionnaire Disability Index (HAQ/HAQ-DI)
• Functional Assessment of Chronic Illness Therapy - Fatigue Subscale (FACIT-Fatigue, Version 4)
• Short Form 36 (SF-36)/Health-Related Quality of Life
• Dermatology Life Quality Index (DLQI)
• Skin Biopsy Substudy
• Immunogenicity assessments

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)

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

Argentina

Brazil

Canada

Chile

Colombia

Czech Republic

France

Germany

Greece

Israel

Italy

Mexico

Peru

Poland

South Africa

Spain

United States

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

LPLV

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

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:

590

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.4.2

For a multinational trial

F.4.2.1

In the EEA

233

F.4.2.2

In the whole clinical trial

656

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)

At the end of the study, BMS will not continue to supply study drug to subjects/investigators unless BMS chooses to extend the study. The investigator should ensure that the subject receives appropriate standard of care to treat the condition under study.

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

2013-08-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-06-08

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-06-30

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials