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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351480
First Posted: May 11, 2011
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Norman B. Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research
  Purpose
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.

Condition Intervention Phase
Rheumatoid Arthritis Biological: abatacept Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Norman B. Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research:

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. [ 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.


Secondary Outcome Measures:
  • 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

  • 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

  • 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.

  • 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


Enrollment: 34
Actual Study Start Date: June 2011
Study Completion Date: April 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
abatacept
open label use of abatacept for 12 months
Biological: abatacept
Abatacept administered SC weekly at 125 mg dose
Other Name: orencia

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351480


Locations
United States, Florida
Arthritis & Rheumatic Disease Specialties Research
Aventura, Florida, United States, 33180
Sponsors and Collaborators
Arthritis & Rheumatic Disease Specialties Research
Bristol-Myers Squibb
Investigators
Principal Investigator: Norman B Gaylis, MD Arthritis & Rheumatic Disease Specialties Research
  More Information

Responsible Party: Norman B. Gaylis, MD, MD, Arthritis & Rheumatic Disease Specialties Research
ClinicalTrials.gov Identifier: NCT01351480     History of Changes
Other Study ID Numbers: IM101-306
First Submitted: May 6, 2011
First Posted: May 11, 2011
Results First Submitted: October 1, 2015
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017
Last Verified: January 2017

Keywords provided by Norman B. Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research:
Auto-immune Disease
Arthritis
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents