Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: abatacept
Intervention description: Abatacept administered SC weekly at 125 mg dose
Intervention MeSH terms: Abatacept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Auto-immune Disease; Arthritis; Rheumatoid Arthritis

Summary:

      The purpose of this study is to determine if the use of sub-cutaneous (SC) abatacept provides
      any structural benefit in patients with rheumatoid arthritis who have failed prior use of TNF
      therapy.
    

Eligibility criteria:

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