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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351480
• Other study ID #: IM101-306
• Status: Completed
• Phase: Phase 3
• First received: May 6, 2011
• Last updated: July 16, 2015
• Start date: June 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2015
• Source: Arthritis & Rheumatic Disease Specialties Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• abatacept
Abatacept administered SC weekly at 125 mg dose

Locations

Country	Name	City	State
United States	Arthritis & Rheumatic Disease Specialties Research	Aventura	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Arthritis & Rheumatic Disease Specialties Research	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		MRIs will be performed at Baseline, Weeks 12, 24, 48	No
Secondary	To measure the change in baseline in Physician DAS 28 score at weeks 12,24,and 48		The DAS 28 score will be performed at baseline, weeks 12, 24 and 48	No
Secondary	To measure the change from baseline in Patient DAS 28 scores at weeks 12, 24 and 48		Patient DAS 28 scores will be measured at baseline, weeks 12, 24 and 48	No
Secondary	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		correlations will be done at weeks 12, 24 and 48	No
Secondary	To measure the onset of clinical and structural improvement as measured by DAS 28 score and MRI findings		measurements will be performed at weeks 12, 24 and 48 and correlated	No
Secondary	To record adverse events to determine safety		all adverse events will be captured from Day 1 and assessed for causality	Yes