NCT02652273

Brief Summary

The purpose of this study is to use abatacept as a clinical molecular probe to evaluate the effects of inhibiting costimulation on immune responses in patients with rheumatoid arthritis (RA).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2016

Typical duration for phase_4

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

January 8, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 11, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

3 years

First QC Date

January 8, 2016

Last Update Submit

January 11, 2016

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

  • Immunological response

    Change in T cell immune response to citrullinated peptides following costimulatory modulation

    Baseline and 12 weeks

Secondary Outcomes (7)

  • Immunological response

    Baseline, 4, 12 and 24 weeks

  • Clinical response American College of Rheumatology (ACR) 20

    Baseline and 24 weeks

  • Clinical response Disease Activity Score (DAS)28

    Baseline and 24 weeks

  • T cell profile

    Baseline, 12 and 24 weeks

  • T cell response

    24 weeks

  • +2 more secondary outcomes

Study Arms (1)

Abatacept

EXPERIMENTAL

Abatacept 125mg administered via subcutaneous injection once a week for 24 weeks

Drug: Abatacept

Interventions

AbataceptDRUG

Abatacept 125mg/ml

Abatacept

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • RA as defined by the 2010 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification 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

You may not qualify if:

  • History of or current autoimmune rheumatic disease other than RA
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NHS Greater Glasgow and Clyde

Glasgow, United Kingdom

Location

Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunoconjugatesAntibodiesImmunoglobulinsSerum GlobulinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsGlobulins

Study Officials

  • Iain McInnes, Prof

    University of Glasgow

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Iain McInnes, Prof

CONTACT

+44 (0)141 330 8412iain.mcinnes@glasgow.ac.uk

Stefan Siebert, Dr

CONTACT

+44 (0) 141 330 3375stefan.siebert@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2016

First Posted

January 11, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

GB(2)