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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01351480
Date of registration: 06/05/2011
Prospective Registration: Yes
Primary sponsor: Arthritis & Rheumatic Disease Specialties Research
Public title: Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients
Scientific 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
Date of first enrolment: June 2011
Target sample size: 34
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01351480
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
United States
Contacts
Name:     Norman B Gaylis, MD
Address: 
Telephone:
Email:
Affiliation:  Arthritis & Rheumatic Disease Specialties Research
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Biological: abatacept
Primary Outcome(s)
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]
Secondary Outcome(s)
Number of Patients With Adverse Events [Time Frame: all adverse events will be captured from Day 1 up to 52 weeks]
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]
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]
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]
Secondary ID(s)
IM101-306
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
Ethics review
Results
Results available: Yes
Date Posted: 13/03/2017
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01351480
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