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

Arthritis & Rheumatic Disease Specialties Research

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: abatacept

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01351480

IM101-306

Details and patient eligibility

About

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.

Full description

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).

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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