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Assessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical Outcomes

Phase 3
18 Years
Open (Enrolling)
Rheumatoid Arthritis

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Trial Information

Assessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical Outcomes

Results in the literature suggest the structural benefits of intravenous (IV) abatacept as
measured by high and low field MRI and X-ray in patients with rheumatoid arthritis who have
previously failed clinical treatment with TNF agents. This study attempts to measure the
structural benefits of SC abatacept in a similar cohort of patients while at the same time
comparing the structural findings with clinical outcome measurements as collected at
corresponding time points with an automated patient and physician disease activity scoring
system of 28 joints (DAS28).

Inclusion Criteria:

- Able and willing to give written informed consent

- Patients must have a diagnosis of rheumatoid arthritis > 3 months

- Patients must have been receiving methotrexate for 12 weeks prior to screening at
a dose of 10mg - 25 mg weekly.

- Patient must have had an inadequate response after receiving or previously receiving
one (1) but no more than two (2) anti-TNF biologic agents

- Age >/= 18 yrs

- Must have active RA as defined by a DAS28 (Erythrocyte sedimentation rate) score >4.4

- Must have synovitis of at least two joints in one hand/wrist at screening and

- Must have a negative Pregnancy test and use adequate method of contraception
throughout the trial

- Stable use of Corticosteroids is permitted

- Stable use of Non-steroidal anti-inflammatory drugs is permitted

Exclusion Criteria:

- Functional Class IV

- Pregnancy or breastfeeding

- History of any other inflammatory arthritis

- Sexually active patients who are not using acceptable birth control

- Subjects who have undergone metacarpophalangeal (MCP) arthroplasty or anticipate the
need for such a procedure

- Subjects with a history of cancer in the last five years other than non melanoma skin

- Subjects who are unable to comply with study and followup procedures

- Subjects who have current or severe symptoms of renal, hepatic, hematologic,
gastrointestinal, pulmonary cardiac, neurologic, or cerebral disease

- Subjects who currently abuse drugs or alcohol

- Subjects with evidence of active or latent bacterial or viral infections at the time
of enrollment

- Subjects who have received live vaccines within 4 months of first dose of study

- Subjects with herpes zoster or cytomegalovirus that resolved less than two months
prior to dosing

- Subjects at risk for tuberculosis (TB). Specifically excluded will be subjects with
a history of active TB within the last 3 years and subjects with latent TB must have
a negative chest X-ray and be started on treatment for at least 28 days prior to

- Prior treatment with Rituximab within 12 months

- Prior treatment with more than 2 TNFs

- Intramuscular(IM), Intravenous(IV) Intra-articular (IA) corticosteroids within 28
days prior to baseline

- Subjects who have a metal device affected by MRI (e.g. any type of electronic,
mechanical or magnetic implant, metal slivers, metal objects, cardioverter

- Subjects who have received any disease modifying agent (DMARD) other than
methotrexate within the past 28 days prior to baseline

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary objective is to evaluate the change from baseline in bone edema/osteitis using low-field MRI in rheumatoid arthritis patients who are using weekly SC abatacept in combination with methotrexate over a 12-month period.

Outcome Time Frame:

MRIs will be performed at Baseline, Weeks 12, 24, 48

Safety Issue:


Principal Investigator

Norman B Gaylis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Arthritis & Rheumatic Disease Specialties Research


United States: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

November 2013

Related Keywords:

  • Rheumatoid Arthritis
  • Auto-immune Disease
  • Arthritis
  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid



Arthritis & Rheumatic Disease Specialties Research Aventura, Florida  33180