Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients

Completed · Phase 3

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01351480

Run by

Arthritis & Rheumatic Disease Specialties Research

People needed

34

Starts

2011-06-01

Expected to finish

2014-04-01

Last updated by the study team

2017-03-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Arthritis & Rheumatic Disease Specialties Research — Aventura, Florida, United States

Full record on ClinicalTrials.gov

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