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

January 23, 2017 updated by: Norman B. Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research

Assessment of Structural Benefits of Injectable Abatacept as Measured by MRI in RA Patients Who Have Failed Prior Anti-Tumor Necrosis (TNF) Therapy and Correlated With Clinical Outcomes

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Aventura, Florida, United States, 33180
        • Arthritis & Rheumatic Disease Specialties Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: abatacept
open label use of abatacept for 12 months
Biological: abatacept
Abatacept administered SC weekly at 125 mg dose
Other Names:
  • orencia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
MRIs at Baseline and Week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients With an Improvement in DAS Score Were Considered Responders at Week 48
Time Frame: 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
The DAS 28 score will be performed at baseline and 48
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24
Time Frame: 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
Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48
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
Time Frame: 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.
week 24 and Week 48
Number of Patients With Adverse Events
Time Frame: 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
all adverse events will be captured from Day 1 up to 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arthritis & Rheumatic Disease Specialties Research

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Norman B Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2011

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 6, 2011

First Submitted That Met QC Criteria

May 10, 2011

First Posted (Estimate)

May 11, 2011

Study Record Updates

Last Update Posted (Actual)

March 13, 2017

Last Update Submitted That Met QC Criteria

January 23, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IM101-306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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