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

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:

MedlinePlus related topics: Edema MRI Scans Rheumatoid Arthritis

Drug Information available for: Abatacept

U.S. FDA Resources

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

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
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

Abatacept
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013