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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 19 February 2015
Main ID:  NCT01333878
Date of registration: 07/04/2011
Prospective Registration: Yes
Primary sponsor: Orrin M Troum, M.D. and Medical Associates
Public title: Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage
Scientific title: An Open-Label, Pilot Trial to Assess the Impact of Subcutaneous Abatacept in Rheumatoid Arthritis Assessing Inhibition of Structural Damage Determined by Low Field Extremity MRI (eMRI) and X-ray
Date of first enrolment: March 2011
Target sample size: 12
Recruitment status: Completed
Study type:  Interventional
Study design:  Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2/Phase 3
Countries of recruitment
United States
Name:     Orrin M Troum, MD
Affiliation:  Orrin M. Troum, MD & Medical Associates
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Subjects currently experiencing active moderate to severe RA according to the revised
1987 ACR criteria for the diagnosis of RA at screening. The ESR-based DAS 28 must be
equal or greater than 3.2

2. MTX inadequate responders with moderate to severe RA. Subjects currently receiving
MTX for at least 12 weeks and who have received MTX at a stable dose (=15mg/week) for
at least 6 weeks prior to treatment (Day 0). They must be biologic drug naive

3. All subjects must receive at least 5 mg oral folic acid weekly.

4. At screening active RA as defined by = 6 swollen joints and = 6 tender joints with
erythrocyte sedimentation rate (ESR) = 28 mm/h.

5. Subjects must be seropositive with documented rheumatoid factor (RF) or anti-cyclic
citrullinated peptide (anti CCP) positivity. If a documented history of RF or anti
CCP positivity is not available, RF and anti CCP titers will be obtained at screening

6. MRI evidence of at least one joint with osteitis or erosion attributable to RA as
determined by an MRI musculoskeletal radiologist. Any joint of the dominant hand or
wrist can be considered with the exception of distal interphalangeal joints of the

7. If subjects are receiving an oral corticosteroid, the dose must be =10 mg/day
prednisone (or equivalent) and stable for at least 28 days prior to treatment (Day

8. Subjects able and willing to give written informed consent and comply with the
requirements of the study protocol. Informed consent must be obtained prior to any
study-related procedures.

A copy of the signed informed consent form must be given to the subject

9. Subjects must be willing to self-inject or allow a caregiver to administer the
subcutaneous injection

Exclusion Criteria:

1. Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization

2. Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus
(SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis, or
significant systemic involvement secondary to RA (vasculitis, pulmonary fibrosis or
Felty's syndrome). Prior history of or current inflammatory joint disease other than
RA (gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis
and psoriatic arthritis)

3. Functional class IV as defined by the ACR Classification of Functional Status in RA

4. Current treatment with any traditional DMARDs other than MTX within 4 weeks before
the screening visit

5. Treatment with any investigational agent within 4 weeks (or 5 half-lives of
investigational agent, whichever is longer) before screening

6. Exposure to any Biologic Response Modifying Agent

7. Intra Articular or parenteral corticosteroids within 6 weeks prior to screening

8. Immunization with live vaccine within 3 months prior to enrollment and a need for a
live vaccine during the study

9. Subjects who have a metal device where the use of MRI is contraindicated (e.g.,any
type of electronic, mechanical, or magnetic implant; cardiac pacemaker, aneurysm
clip; implanted cardioverter defibrillator; or a cochlear implant). Subjects who have
a potential ferromagnetic foreign body (metal shavings, metal slivers, other metal
objects) for which they have sought medical attention

10. Exclusionary laboratory: Serum creatinine >2 mg/dL, ALT or AST > 2.0 x ULN, total
bilirubin > 2.0 x ULN, platelet count <100 x 109 /L, hemoglobin < 8.5 g/dL, WBC count
< 1,000/mm3 , absolute neutrophil count < 1,000/ mm3, absolute lymphocyte count <
500/mm3, positive HBsAg or HCV antibody, or positive HIV test.

11. Pregnant women or nursing mothers

12. Females of child bearing potential who are not using reliable means of contraception

13. Evidence of serious uncontrolled concomitant cardiovascular, nervous system,
pulmonary, renal, hepatic, endocrine or GI disease

14. Uncontrolled disease states, such as asthma, psoriasis, or inflammatory bowel
syndrome, where flares are commonly treated with corticosteroids

15. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial,
or other infections such as atypical mycobacterial disease, hepatitis B and C, HIV,
herpes zoster, or any major episode of infection requiring hospitalization or
treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within
2 weeks prior to screening.

16. A history of active TB within the last 3 years even if it was treated. 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. A positive PPD skin test (=5
mm) or positive QuantiFERON-TB Gold serum test without appropriate prophylaxis (at
least 1 month of the planned local guidelines treatment regimen)

17. Any malignancy except for skin cancer (basal cell or squamous cell) diagnosed within
the previous 5 years

18. History of alcohol, drug, or chemical abuse

19. Neuropathies or other painful conditions that might interfere with pain evaluation

Age minimum: 18 Years
Age maximum: N/A
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Biological: Subcutaneous Abatacept
Primary Outcome(s)
Inhibition & progression of structural damage [Time Frame: 6 months]
Secondary Outcome(s)
Improvement in ESR-based DAS28 [Time Frame: 6 months]
Secondary ID(s)
BMS IM101-281
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
Ethics review
Results available:
Date Posted:
Date Completed:
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