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

NCT ID: NCT01351480

Last Updated: 2017-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-04-30

Brief 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.

Detailed 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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

abatacept

open label use of abatacept for 12 months

Group Type: OTHER

abatacept

Intervention Type: BIOLOGICAL

Abatacept administered SC weekly at 125 mg dose

Interventions

abatacept

Abatacept administered SC weekly at 125 mg dose

Intervention Type: BIOLOGICAL

Other Intervention Names

orencia

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Arthritis & Rheumatic Disease Specialties Research

OTHER

Sponsor Role: lead

Responsible Party

Norman B. Gaylis, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Norman B Gaylis, MD

Role: PRINCIPAL_INVESTIGATOR

Arthritis & Rheumatic Disease Specialties Research

Locations

Arthritis & Rheumatic Disease Specialties Research

Aventura, Florida, United States

Countries

United States

Other Identifiers

IM101-306

Identifier Type: -

Identifier Source: org_study_id