Clinical trial NCT01351480: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Auto-immune Disease
Arthritis
Rheumatoid Arthritis
Lead sponsor: Arthritis & Rheumatic Disease Specialties Research
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2011-05-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: 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.
timeFrame: MRIs at Baseline and Week 48
Secondary outcomes:
measure: Patients With an Improvement in DAS Score Were Considered Responders at Week 48
timeFrame: The DAS 28 score will be performed at baseline and 48
measure: To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24
timeFrame: Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48
measure: 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
timeFrame: week 24 and Week 48
measure: Number of Patients With Adverse Events
timeFrame: all adverse events will be captured from Day 1 up to 52 weeks
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Arthritis & Rheumatic Disease Specialties Research
state: Florida
Study officials:
affiliation: Arthritis & Rheumatic Disease Specialties Research
name: Norman B Gaylis, MD
role: PRINCIPAL_INVESTIGATOR
References: