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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Norman B. Gaylis, MD, Arthritis & Rheumatic Disease Specialties Research
ClinicalTrials.gov Identifier:
NCT01351480
First received: May 6, 2011
Last updated: March 1, 2013
Last verified: March 2013
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Arthritis & Rheumatic Disease Specialties Research:

Primary Outcome Measures:
  • The primary objective is to evaluate the change from baseline in bone edema/osteitis using low-field MRI in rheumatoid arthritis patients who are using weekly SC abatacept in combination with methotrexate over a 12-month period. [ Time Frame: MRIs will be performed at Baseline, Weeks 12, 24, 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To measure the change in baseline in Physician DAS 28 score at weeks 12,24,and 48 [ Time Frame: The DAS 28 score will be performed at baseline, weeks 12, 24 and 48 ] [ Designated as safety issue: No ]
  • To measure the change from baseline in Patient DAS 28 scores at weeks 12, 24 and 48 [ Time Frame: Patient DAS 28 scores will be measured at baseline, weeks 12, 24 and 48 ] [ Designated as safety issue: No ]
  • To correlate the clinical outcomes measurements (American College of Rheumatology activity scoring, Health Assessment questionnaires, and C-reactive Protein) to structural improvement (bone edema/osteitis) at weeks 12, 24, 48 [ Time Frame: correlations will be done at weeks 12, 24 and 48 ] [ Designated as safety issue: No ]
  • To measure the onset of clinical and structural improvement as measured by DAS 28 score and MRI findings [ Time Frame: measurements will be performed at weeks 12, 24 and 48 and correlated ] [ Designated as safety issue: No ]
  • To record adverse events to determine safety [ Time Frame: all adverse events will be captured from Day 1 and assessed for causality ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 6, 2011
Last Updated: March 1, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Arthritis & Rheumatic Disease Specialties Research:
Auto-immune Disease
Arthritis
Rheumatoid Arthritis

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

ClinicalTrials.gov processed this record on October 29, 2014