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Inflammatory ArthritisPhase 2ARCADIANCT04261023

Abatacept in Individuals Who aRe Considered At Risk of Developing Inflammatory Arthritis

A Phase 2 study testing Orencia 125 MG Per 1 ML Prefilled Syringe in people with Inflammatory Arthritis, run by University of Leeds at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase II, single-centre, open label, two parallel arm cohort randomised controlled trial (RCT) testing abatacept in a population of anti-CCP Ab positive individuals at moderate to high risk of developing IA according to a published risk score, already followed in the observational study 'CCP: Next Generation' Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Inflammatory Arthritis
What is being tested?
Orencia 125 MG Per 1 ML Prefilled Syringe
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited Kingdom
Study dates
24 Feb 2020to 15 Mar 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant in Leeds CCP 'Next Generation' observational cohort who has tested positive for anti-CCP Ab and accepted to be approached for a interventional study
  • Age >18 years old.
  • At moderate to high risk of progression to IA (see below).
  • Consents to be contacted in future for an interventional study
  • A prediction model will be used to risk stratify individuals based on the following predictors:
  • Tenderness of ≥1 small joint of the hands or feet defined by the physician (one point)
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  • Early morning stiffness ≥30 minutes (one point)
  • RF and/or anti-CCP Ab concentration >3x upper limit of normal. (2 points) The participant's risk will be calculated according to the model suggested by Rakieh et al. (1). Those with a score of ≥3 out of 4 will be eligible to be randomised.
  • For the intervention arm:
  • Randomised to intervention arm
  • Consents to commence Abatacept therapy (if not, will remain in CCP Next-generation study)
  • For the control arm:
  • Randomised to the control arm
  • Will remain in the CCP Next-generation study

Who cannot join

  • For both the intervention and control arms:
  • Previous diagnosis of RA or other form of inflammatory arthritis including, but not limited to SLE, psoriatic arthritis, ankylosing spondylitis, gout or pyrophosphate arthropathy and including current treatment with DMARDs or biological therapy
  • Clinical synovitis on clinical examination by a rheumatologist
  • Presence of concomitant illness likely to require systemic glucocorticosteroid therapy during the study, in the opinion of the investigator
  • Treatment with an intravenous, intramuscular, intrabursal or intraarticular corticosteroid within 12 weeks prior to randomization
  • Co-morbidities requiring chronic treatment with immunosuppressive or immune modulating therapy.
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  • Women in the intervention arm who get pregnant during the study will be withdrawn from treatment and followed for the duration of the pregnancy for safety purposes. All participants who get pregnant will continue to be followed up in clinic as standard NHS care to collect secondary end point data
  • Evidence of active or latent bacterial or viral infection at the time of potential enrolment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrolment
  • Individuals with palindromic rheumatism
  • For the intervention arm only:
  • History of acute allergic reactions to biologic therapies or immunoglobulins
  • Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to RA and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study
  • Subjects who have at any time received treatment with any investigational drug within 28 days of the first dose of study drug
  • Subjects who test positive for Hepatitis B, C or HIV.
  • Subjects with tuberculosis (TB), including those at high risk of TB, chronic viral infections, recent serious bacterial infections, subjects receiving live vaccinations within 3 months of the anticipated first dose of study medication, or those with chronic illnesses that would, in the opinion of the investigator, put the participant at risk
  • Subjects who currently abuse drugs or alcohol
  • Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ
  • Scheduled for or anticipating joint replacement surgery
  • Men or women unwilling to use an acceptable method of contraception (detailed in 7.1.4) to avoid pregnancy for up to 14 weeks after the last dose of trial medication
  • Women of childbearing potential with a positive serum or urine pregnancy test within 48 hours prior to the baseline visit. Women of child bearing potential are defined as women who have had any menstrual bleeding in the last 24 months and who have not had a hysterectomy or surgical sterilisation
  • Evidence of active or latent bacterial or viral infection at the time of potential enrolment, including human immunodeficiency or herpes zoster virus or cytomegalovirus that resolved less than 2 months prior to enrolment
  • Inadequate haematological, hepatic or renal function within 28 days of treatment:
  • Haemoglobin <8.5 g/dL
  • White blood cells <3000/mm3
  • Platelets <100,000/mm3
  • Serum creatinine, ALT or AST >2 times upper limit of normal
  • Any other laboratory test result that, in the opinion of the study investigator, might place the participant at unacceptable risk for participation in the study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital

    Leeds, WEST Yorkshire, LS7 4SA

Other trials in United Kingdom

About this study

Official title: Phase II Proof of Concept Study of Abatacept (Orencia) in Individuals Who aRe Considered At Risk of Developing Inflammatory Arthritis

Phase II, single-centre, open label, two parallel arm cohort randomised controlled trial (RCT) testing abatacept in a population of anti-CCP Ab positive individuals at moderate to high risk of developing IA according to a published risk score, already followed in the observational study 'CCP: Next Generation'

Read the detailed description

There is now evidence that the immunological disease process starts many years before the onset of clinically detectable inflammatory arthritis (IA). It is now a realistic goal to treat individuals in this pre-clinical phase with the possibility of arresting their progression to clinical disease.

Individuals at risk of developing RA can be identified by the presence of CCP antibodies alongside other clinical features. In Leeds we have developed a prediction model that stratifies these individuals into at-risk vs. low risk. At present there are no treatments in this pathway until individuals develop IA.

T-cells appear to be an appropriate target in at-risk individuals as they play a critical role in the generation and maintenance of autoimmunity. Abatacept (Orencia) is a selective T-cell modulator that blocks a co-stimulatory signal needed to activate T-cells and has an excellent safety profile.

Being tested
Orencia 125 MG Per 1 ML Prefilled Syringe
Keywords
Abatacept (Orencia)
Medical subject headings
Arthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Orencia 125 MG Per 1 ML Prefilled SyringeDrug

    Also called Abatacept

    Abatacept sub-cutaneous injection 125mg at week 0 and once weekly thereafter for a maximum of 48 weeks

Study groups in NCT04261023
Study groupRoleWhat they receive
AbataceptExperimentalTreatment arm - 125mg sub-cutaneous injection at week 0 and once weekly thereafter for a maximum of 48 weeks
Receives: Drug: Orencia 125 MG Per 1 ML Prefilled Syringe
Control arm - CCP Next GenerationNo interventionObservational study cohort - usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Individuals who develop inflammatory arthritis

    The percentage of individuals that have developed inflammatory arthritis at 48 weeks

    Measured: 48 weeks

Secondary outcomes (7)

  1. Acute phase reactant levels

    Acute phase reactant levels at weeks 12, 24, 36, 48, 60, 72, 84 and 96

    Measured: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  2. Ultrasound synovitis and erosions

    Power Doppler to record quantitative scoring 0-3 and erosions

    Measured: Weeks 24, 48, 72 and 96

  3. Plain radiograph

    Plain radiograph Sharp Van der Heide score 0-5

    Measured: Weeks 48 and 96

  4. Patient-reported measures

    Physician assessment of global disease activity 0-100mm

    Measured: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  5. Joint swelling and tenderness

    28/44 joint count of all tender and swollen joints via diagram

    Measured: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  6. T-cell subset levels

    T-cell subset levels

    Measured: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

  7. Toxicity levels

    Toxicity levels according to the common toxicity criteria gradings

    Measured: Weeks 12, 24, 36, 48, 60, 72, 84 and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2020
  2. Study start24 Feb 2020
  3. Primary completion15 Mar 2021
  4. Study completion15 Mar 2021

Why it stopped: The CI terminated ARCADIA early due to a number of reasons. These include the difficulty in recruiting and being placed on pause during the COVID pandemic, plus limited staffing at that time \& the need to considerably amend the eCRF MACRO system

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04261023
Sponsor's protocol ID
RR15/348
Acronym
ARCADIA
Status last verified
Mar 2025
First submitted
30 Jan 2020
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Orencia 125 MG Per 1 ML Prefilled Syringe in people with Inflammatory Arthritis, run by University of Leeds at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The CI terminated ARCADIA early due to a number of reasons. These include the difficulty in recruiting and being placed on pause during the COVID pandemic, plus limited staffing at that time \& the need to considerably amend the eCRF MACRO system). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Individuals who develop inflammatory arthritis (time frame: 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04261023.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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