Efficacy and Safety of Abatacept Subcutaneous (SC) in Combination with Methotrexate in Adults with very early Rheumatoid Arthritis (RA)
- Conditions
- Rheumatoid ArthritisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
- Registration Number
- EUCTR2010-018674-20-BE
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 470
1/ Signed Written Informed Consent
a) Subject is willing to participate in the study and signed the informed consent
2/ Target Population
a) Subjects have active clinical synovitis of at least 2 joints, 1 of which must be a
small joint, for at least 8 weeks at the Screening Visit. Distal interphalangeal
joints (DIP)s do not count toward this requirement
b) Subjects have had the onset of persistent symptoms for = 2 years prior to the
Screening Visit.
c) Subjects have a DAS28-CRP = 3.2 at the Screening Visit
d) Subjects are positive for anti-CCP2.
e) Subjects are MTX naive or have minimum exposure to MTX defined as no more
than 10 mg/wk for no more than 4 weeks and no dose for 1 month prior to the
Screening Visit.
f) Subjects are biologic naive and have not received treatment with an approved or
investigational biologic RA therapy (for ex, infliximab, etanercept, anakinra,
adalimumab, rituximab, tocilizumab, golimumab, and certolizumab) prior to
screening.
.g) Subjects receiving chloroquin, hydroxychloroquine and sulfasalazine
must stop
treatment (wash-out) for a minumum of 28 days prior to randomization.
h) Subjects receiving oral corticosteroids must be on a stable dose and
at theequivalent of = 10 mg prednisone daily for = 4 weeks or may have
received an IM, IV or IA administration of a corticosteroid = 4 weeks
prior to randomization
3/ Age and Reproductive Status
a) Men and women, ages = 18
b) Men and women of childbearing potential (WOCBP) must be using an
acceptable
method of contraception to avoid pregnancy throughout the study for up
to
10 weeks (14 weeks for EU) after the last dose of abatacept in such a
manner that
the risk of pregnancy is minimized. See Protocol Section 3.3.4 for the
definition of WOCBP.
c) Women must have a negative serum or urine pregnancy test
(minimum sensitivity
25 IU/L or equivalent units of HCG) within 48 hours prior to the start of
investigational product.
d) Women must not be breastfeeding
e) Investigators should follow the manufacturer's recommendations for
MTX.
f) Subjects must be able to receive an MRI. See Protocol Section 3.3.4
for contraindications.
Are the trial subjects under 18? no
Number of subjects for this age range:
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
1/ Target Disease Exceptions
a) Subjects who meet diagnostic criteria for other rheumatic disease
(eg, lupus
erythematosus).
2/ Medical History and Concurrent Diseases
a) Subjects who are impaired, incapacitated, or incapable of completing
study
related assessments.
b) Current symptoms of severe, progressive, or uncontrolled renal,
hepatic,
hematological, gastrointestinal, pulmonary, cardiac, neurological, 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.
c) 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
d) Subjects with a history of cancer within the last 5 years (other than
non-melanoma skin cell cancers cured by local resection). Existing nonmelanoma
skin cell
cancers must be removed prior to dosing. Subjects with carcinoma in
situ, treated
with definitive surgical intervention prior to study entry, are allowed.
e) Subjects who have clinically significant drug or alcohol abuse.
f) Subjects with any serious acute bacterial infection (such as
pneumonia or
pyelonephritis unless treated and completely resolved with antibiotics).
g) Subjects with severe chronic or recurrent bacterial infections (such as
recurrent
pneumonia, chronic bronchiectasis).
h) Subjects at risk for tuberculosis (TB). Specifically, subjects with:
i) Current clinical, radiographic or laboratory evidence of active TB.
ii) A history of active TB within the last 3 years even if it was treated.
iii) A history of active TB greater than 3 years ago unless there is
documentation
that the prior anti-TB treatment was appropriate in duration and type.
iv) Latent TB which was not successfully treated. Subjects with a
positive TB
screening test indicative of latent TB will not be eligible for the study
unless
active TB infection has been ruled out and they have initiated treatment
for
latent TB with isoniazid (INH) for at least 4 weeks prior to dosing of
study
drug and they have a negative chest x-ray at enrollment. Such subjects
should
complete 9 months of INH treatment.
i) Subjects with herpes zoster that resolved less than 2 months prior to
enrollment.
j) 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) infection
3/ Physical and Laboratory Test Findings
a) Hepatitis B surface antigen-positive subjects.
b) Hepatitis C antibody-positive subjects who are also RIBA-positive 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/ Allergies and Adverse Drug Reaction
a) None
5/ Prohibited Treatments and/or Therapies
a) Subjects who have had prior exposure to abatacept (CTLA4-Ig)
b) Subjects who have been exposed to any investigational drug within 4
weeks or
5 hal
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method