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

Phase 3

Completed

Conditions: Rheumatoid Arthritis

Interventions: Biological: abatacept

Registration Number: NCT01351480

Lead Sponsor: Arthritis & Rheumatic Disease Specialties Research

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 34

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
abatacept	abatacept	open label use of abatacept for 12 months

Primary Outcome Measures

Name	Time	Method
Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.	MRIs at Baseline and Week 48	bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.

Secondary Outcome Measures

Name	Time	Method
Number of Patients With Adverse Events	all adverse events will be captured from Day 1 up to 52 weeks	site will report the number of patients with adverse envents from Day 1 up to 52 weeks
Patients With an Improvement in DAS Score Were Considered Responders at Week 48	The DAS 28 score will be performed at baseline and 48	Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24	Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48	DAS 28\> 5.1=high disease activity DAS28 \<3.2=low disease activity DAS28 \<2.6=remission Criteria used in formula are number of tender joints based upon 28 joints, number of swollen joints based on 28 joints, ESR in mm/hr and patient global health core based on 0-10 mm
the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48	week 24 and Week 48	Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score (1-10 cm). Total maximum score was at high disease activity at baseline.