Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
25 participants
INTERVENTIONAL
2016-01-31
2019-01-31
Brief Summary
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Detailed Description
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Abatacept is designed to target and inhibit a specific molecule involved in "costimulation" of the inflammatory signal that is thought to be important in RA. While abatacept has been shown to be effective in trials and clinical practice, the exact mechanism of action of abatacept in RA has not been fully elucidated. Understanding these actions is likely to inform both the use of abatacept in RA and lead to increased understanding of inflammation in humans with implications for further therapies. This six month prospective open label study, therefore, aims to investigate the effects of inhibiting costimulation on a variety of important inflammatory cell types and processes in humans with RA.
25 participants with RA who have bad prognostic genetic markers (Anti-citrullinated protein antibodies (ACPA) and human leukocyte antigen (HLADR4) and who were scheduled to receive subcutaneous abatacept as part of their standard clinical treatment will be recruited. Consenting participants will followed for a total of 24 weeks during which time they will have additional venous blood and urine samples taken to investigate the effects of abatacept on their immune cells and system. The primary endpoint of the study is the characterisation of the immune response following costimulatory modulation in RA patients at 12 weeks. Secondary endpoints include change in immunological response and its association with clinical outcome measures up to 24 weeks.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Abatacept
Abatacept 125mg administered via subcutaneous injection once a week for 24 weeks
Abatacept
Abatacept 125mg/ml
Interventions
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Abatacept
Abatacept 125mg/ml
Eligibility Criteria
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Inclusion Criteria
* Eligible for abatacept therapy according to local/national guidelines
* Active RA defined by DAS28 score required by local guidelines for eligibility for abatacept
* Have previously failed (efficacy or tolerance) at least one disease-modifying antirheumatic drug (DMARD)
* Have no contraindications to treatment with abatacept
* Be able to tolerate methotrexate at dose of 10-25mg/week, either orally or subcutaneously
* Anti-cyclic citrullinated peptide (CCP) positive
* Human leukocyte antigen D related (HLA-DR) B1\*0401 or 0404) positive
* Able and willing to give written informed consent and comply with the requirements of the study protocol
Exclusion Criteria
* Concomitant use of any biologic agent, including tumor necrosis factor (TNF) inhibitors
* Previous abatacept treatment
* Patients requiring \>10mg prednisolone daily or intramuscular (IM) corticosteroids
* Active infection
* Known HIV or hepatitis B/C infection
* Latent tuberculosis (TB) infection
* Malignancy (other than non-melanoma skin cell cancers) within 5 years
* Women who are pregnant, women of childbearing potential who are unwilling to use appropriate contraception or breast-feeding
* Inability to give informed consent
18 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Principal Investigators
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Iain McInnes, Prof
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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NHS Greater Glasgow and Clyde
Glasgow, , United Kingdom
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2014-004419-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GN13RH410
Identifier Type: -
Identifier Source: org_study_id
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