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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
abatacept
Sponsored by
Arthritis & Rheumatic Disease Specialties Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Auto-immune Disease, Arthritis, Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Arthritis & Rheumatic Disease Specialties Research

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

abatacept

Arm Description

open label use of abatacept for 12 months

Outcomes

Primary Outcome Measures

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.
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

Patients With an Improvement in DAS Score Were Considered Responders at 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
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24
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
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.
Number of Patients With Adverse Events
site will report the number of patients with adverse envents from Day 1 up to 52 weeks

Full Information

First Posted
May 6, 2011
Last Updated
January 23, 2017
Sponsor
Arthritis & Rheumatic Disease Specialties Research
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01351480
Brief Title
Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arthritis & Rheumatic Disease Specialties Research
Collaborators
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Auto-immune Disease, Arthritis, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
abatacept
Arm Type
Other
Arm Description
open label use of abatacept for 12 months
Intervention Type
Biological
Intervention Name(s)
abatacept
Other Intervention Name(s)
orencia
Intervention Description
Abatacept administered SC weekly at 125 mg dose
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
MRIs at Baseline and Week 48
Secondary Outcome Measure Information:
Title
Patients With an Improvement in DAS Score Were Considered Responders at Week 48
Description
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
Time Frame
The DAS 28 score will be performed at baseline and 48
Title
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24
Description
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
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
Title
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
Description
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.
Time Frame
week 24 and Week 48
Title
Number of Patients With Adverse Events
Description
site will report the number of patients with adverse envents from Day 1 up to 52 weeks
Time Frame
all adverse events will be captured from Day 1 up to 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norman B Gaylis, MD
Organizational Affiliation
Arthritis & Rheumatic Disease Specialties Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arthritis & Rheumatic Disease Specialties Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

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

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