Clinical Trials Register

Summary
EudraCT Number:	2007-004241-15
Sponsor's Protocol Code Number:	IM101-158
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2008-02-14
Trial results	Removed from public view

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

Belgium - FPS Health-DGM

A.2

EudraCT number

2007-004241-15

A.3

Full title of the trial

A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled
Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis.
Revised Protocol 01 incorporating Protocol Amendment 03 (v2.0, dated 16-Oct-2008).

A.4.1

Sponsor's protocol code number

IM101-158

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	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
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	Orencia
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb Company
D.2.1.2	Country which granted the Marketing Authorisation	United States
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	Powder for solution for infusion
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
D.3.7	Routes of administration for this IMP	Intravenous 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.3.9.3	Other descriptive name	CTLA4Ig
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	250
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	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 infusion
D.8.4	Route of administration of the placebo	Intravenous use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Psoriatic Arthritis

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	9.1
E.1.2	Level	LLT
E.1.2	Classification code	10037160
E.1.2	Term	Psoriatic arthritis

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Double-Blind:
To compare the efficacy of 3 regimens of abatacept vs. placebo in a 6-month double-blind study of psoriatic arthritis, as measured by the proportion of subjects achieving an ACR20 response (American College of Rheumatology 20% response) at Day 169.

Open-label:
To assess the safety and tolerability of abatacept treatment during the open-label
extension phase (18 months after the initial 6-month, double-blind period).

E.2.2

Secondary objectives of the trial

1. To estimate the difference in proportion of subjects achieving an Investigator Global Assessment (IGA) score of clear or almost clear in each of the 3 abatacept arms compared to placebo at Day 169.
2. To estimate the difference in mean percentage change from baseline in each of the 3 abatacept arms compared to placebo in target lesion scores at Day 169.
3. To estimate the difference in mean changes from baseline in physical and mental
functions as measured by SF-36 in each of the 3 abatacept arms compared to placebo at Day 169
4. To estimate the difference in proportion of subjects with a diminution in disabilities
as measured by HAQ scores between the 3 abatacept arms placebo at Day 169.
5. To describe the safety, tolerability, immunogenicity, and to predict the
pharmacokinetics of each of the 3 abatacept arms using population pharmacokinetics
(POPPK) methodology.

Open-label: see section 2.3.2 of the protocol

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1) Signed Written Informed Consent
2) Target Population
a) meet Classification Criteria for Psoriatic Arthritis (CASPAR) (Appendix 3)
for a duration of disease at least 3 months
b) prior failure of DMARD therapy (inefficacy or intolerance); if patient had
prior failure of methotrexate, s/he must have been on at least 15 mg/week dose
for at least 2 months
c) if recent failure of a TNFα blockade compound (inefficacy or intolerance),
must be washed out prior to first dose: 56 days for infliximab and 28 days for
etanercept and adalimumab
d) disease activity as defined by a tender joint count of ≥ 3, swollen joint count
of ≥ 3 and clinically detectable synovitis at screening and Day 01 (prior to
infusion)
e) have active psoriasis with a qualifying target lesion ≥ 2 cm in diameter
f) Must be able to have MRI performed.
3) Age and Sex
a) Men and women (not nursing and not pregnant) ≥ 18 years of age at the time
of informed consent.
b) Women of childbearing potential (WOCBP) must be using an adequate
method of contraception to avoid pregnancy throughout the study and for up
to 10 weeks after the last dose of investigational product in such a manner that
the risk of pregnancy is minimized.

E.4

Principal exclusion criteria

1. Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method to avoid
pregnancy for the entire study period and for up to 10 weeks after the last
dose of investigational product
b) Women who are pregnant or breastfeeding, or plan to become pregnant, or to
start breastfeeding during the duration of the study
c) Women with a positive pregnancy test on enrollment or prior to
investigational product administration.
2) Medical History and Concurrent Diseases
a) Subjects who are scheduled for or anticipate joint replacement surgery.
b) Subjects who have a recent history of clinically significant drug or alcohol
abuse
c) Concomitant illness that in the opinion of the Investigator, is likely to require
systemic glucocorticosteroid therapy during the study (e.g.; moderate to
severe asthma)
d) Current symptoms of severe, progressive, or uncontrolled renal, hepatic,
hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral
disease. Concomitant medical conditions that in the opinion of the
Investigator might place the subject at unacceptable risk for participation in
this study
e) Subjects who are unwilling or unable to have screening performed based on
current local or country guidelines/standards to evaluate the presence of
cancer (e.g. breast, cervical, colon, prostate, hepatocellular, gastric).
f) Subjects with a history or current evidence of malignancies; specifically,
subjects with:
• a history of cancer within the last five years (other than non-melanoma
skin cell cancers cured by local resection), or
• evidence of current malignancy or signs of possible malignancy
detected by screening procedures for which the workup to exclude malignancy has not been completed or malignancy cannot be excluded.
• Female subjects who have had a manual examination or breast cancer
imaging (mammogram, ultrasound, other method) 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 (see Section 6.3.4).
g) Subjects at risk for tuberculosis (TB).
h) Subjects with any serious bacterial infection within the last 3 months, not
treated and resolved with antibiotics, or any chronic bacterial infection (such
as, but not limited to, chronic pyelonephritis, osteomyelitis and
bronchiectasis)
i) Subjects with evidence (as assessed by the Investigator) of active or latent
bacterial or viral infections at the time of potential enrollment, including
subjects with evidence of Human Immunodeficiency Virus (HIV).
j) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than
2 months prior to signing informed consent
k) Subject who have received any live vaccines within 3 months of the
anticipated first dose of study medication or who will have need of a live
vaccine at any time, during and for 3 months after the duration of the study.
3) Physical and Laboratory Test Findings
a) Subjects with Hepatitis B surface antigen.
b) Subjects with Hepatitis C antibody-positive subjects who are also RIBApositive
or PCR positive.
c) Subjects with any of the following laboratory values:
i. Hgb < 8.5 g/dL.
ii. WBC < 3,000/mm3 (3 x 109/L)
iii. Platelets < 100,000/mm3 (100 x 109/L).
iv. Serum creatinine > 2 times upper limit of normal.
v. Serum ALT or AST > 2 times upper limit of normal.
vi. Any other laboratory test results that, in the opinion of the investigator,
might place the subject at unacceptable risk for participation in this study.
4) Prohibited Treatments and/or Therapies
a) Subjects who are scheduled for or anticipate joint replacement surgery.
b) Subjects who have at any time received treatment with CTLA4Ig,
BMS-188667 (abatacept).
c) Subjects who have received treatment with any investigational drug within 28
days (or less than 5 terminal half-lives of elimination) of the Day 01 dose.
d) Subjects currently receiving treatment with molecular biologic therapies.
e) Any approved or investigational biologics.
5) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated
b) Subjects who are compulsorily detained for treatment of either a psychiatric
or physical (eg, infectious disease) illness

E.5 End points

E.5.1

Primary end point(s)

Safety outcomes include adverse events, clinically significant
changes in vital signs, laboratory test abnormalities, and clinical tolerability of the drug.

Efficacy:
The primary efficacy outcome measure for this study is an ACR20 response at study Day 169.
A secondary objective of this study is to estimate the difference in proportion of subjects who achieve an IGA sc ore of clear or almost clear in each of the 3 abatacept arms compared to placebo at 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

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

MRI

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

Yes

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

Yes

E.8.1.7.1

Other trial design description

6 months double-blind then 18 months open-label

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

Yes

E.8.2.3.1

Comparator description

3 abatacept doses

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

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

Yes

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	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
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	8
F.4.2	For a multinational trial
F.4.2.1	In the EEA	72
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

2008-01-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2008-04-01

P. End of Trial
P.	End of Trial Status	Completed

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IMP with orphan designation in the indication
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