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

NCT04261023 | Terminated Phase 2

• 1 other identifier: RR15/348
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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'

Conditions

Inflammatory Arthritis

Keywords

Abatacept (Orencia)

Outcome Measures

Primary Outcomes (1)

• Individuals who develop inflammatory arthritis

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

  48 weeks

Secondary Outcomes (7)

• Acute phase reactant levels

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

• Ultrasound synovitis and erosions

  Weeks 24, 48, 72 and 96

• Plain radiograph

  Weeks 48 and 96

• Patient-reported measures

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

• Joint swelling and tenderness

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

Study Arms (2)

Abatacept

EXPERIMENTAL

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

Drug: Orencia 125 MG Per 1 ML Prefilled Syringe

Control arm - CCP Next Generation

NO INTERVENTION

Observational study cohort - usual care

Interventions

Orencia 125 MG Per 1 ML Prefilled Syringe DRUG

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

Also known as: Abatacept

Abatacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Leeds: lead

Study Sites (1)

Institute of Rheumatic & Musculoskeletal Medicine, Chapel Allerton Hospital

Leeds, WEST Yorkshire, LS7 4SA, United Kingdom

Location

MeSH Terms

Conditions

Arthritis

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Rheumatology

Study Record Dates

• First Submitted: January 30, 2020
• First Posted: February 7, 2020
• Study Start: February 24, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 30, 2025

Record last verified: 2025-03

Locations

GB (1)