Arthritis prevention with abatacept

Arthritis Prevention In the Pre-clinical Phase of RA with Abatacept. - APIPPRA

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003413-18-GB

Enrollment

206

Registered

2014-04-04

Start date

2014-05-13

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The target population for therapeutic intervention will be subjects who carry serum autoantibodies (antibodies to citrullinated protein antigens – ACPA

Interventions

Trade Name: ORENCIA 125 mg solution for injection Pharmaceutical Form: Solution for infusion in pre-filled syringe Pharmaceutical form of the placebo: Solution for infu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Male or female subjects, aged = 18 years. - Arthralgia that is considered to be inflammatory in nature. - ACPA and RF positive, or high titre ACPA. - Able and willing to give written informed consent and comply with the requirements of the study protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 206 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 206

Exclusion criteria

Exclusion criteria: - Clinically apparent arthritis, as assessed by a rheumatologist. - A history of inflammatory arthritis, as assessed by a rheumatologist. - History or current use of DMARDs or biologics. - History of oral or parenteral use of corticosteroids within the last 12 weeks. - Co-morbidities requiring treatment with immunosuppressive or immune modulating therapy. - Chronic illnesses that would, in the opinion of the investigator, put the subject at risk. - Recipients of a live vaccine within 3 months of inclusion. - Pregnant or breastfeeding - Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: Every 3 months for up to 24 months;Main Objective: To evaluate the feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.;Secondary Objective: To characterise immune and inflammatory responses associated with ACPA before, during and after therapy with abatacept.; Primary end point(s): 1) The time to development of clinically apparent synovitis in = 3 joints, as determined by two independent assessors with experience in clinical assessment of RA 2) The time to development of RA according to the ACR/EULAR 2010 criteria, where joint involvement is defined as joint swelling. In either case joint swelling will be confirmed by ultrasound.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: Every 3 months for up to 24 months;Main Objective: To evaluate the feasibility, efficacy and acceptability of abatacept therapy in subjects at high risk of developing RA.;Secondary Objective: To characterise immune and inflammatory responses associated with ACPA before, during and after therapy with abatacept.; Primary end point(s): 1) The time to development of clinically apparent synovitis in = 3 joints, as determined by two independent assessors with experience in clinical assessment of RA 2) The time to development of RA according to the ACR/EULAR 2010 criteria, where joint involvement is defined as joint swelling. In either case joint swelling will be confirmed by ultrasound.

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Secondary

Measure	Time frame
Secondary end point(s): 1) The development of RA according to the ACR/EULAR 2010 criteria where ultrasound 2) Assessments of disease activity and progression over time, using DAS28 (tender and swollen joint counts, patient global visual analogue score (VAS), ESR) and Extended Joint Count 68/66, Simple Disease Activity Score (SDAI) and Clinical Disease Activity Score (CDAI), Pain VAS, Lifestyle Factors Questionnaire, Health Assessment Questionnaire (HAQ), Modified Illness Perception Questionnaire (Modified IPQ-R), Euro-Quality of Life Questionnaire (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Work Instability Scale (RA-WIS), Functional Assessment Of Chronic Illness Therapy-Fatigue (FACIT-F) and Symptoms in Persons At Risk of Rheumatoid Arthritis (SPARRA) questionnaire. 3) The proportion of participants requiring DMARD therapy, and the time to commencing DMARD therapy, including oral or parenteral corticosteroids. 4) Progression of radiographic changes in X-rays of the hands and feet scored by van der Heijde Sharpe Modified Scores or using the Larsen score. 5) Changes in scores of synovitis and vascularity defined by high resolution ultrasonography and power Doppler over time. 6) Adverse events. The exploratory endpoints of this study are: 1) Changes in serum ACPA levels over time. 2) ACPA isotype and antigenic fine specificity over time. 3) Signatures of immune and inflammatory responses as defined through analysis of serum, peripheral blood cell subsets, peripheral blood RNA expression profiling and urine. ; Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated every 3 months for up to 24 months The exploratory endpoints will be evaluated at the end of the study following analysis of the biological samples.	—

Measure

Time frame

Secondary end point(s): 1) The development of RA according to the ACR/EULAR 2010 criteria where ultrasound 2) Assessments of disease activity and progression over time, using DAS28 (tender and swollen joint counts, patient global visual analogue score (VAS), ESR) and Extended Joint Count 68/66, Simple Disease Activity Score (SDAI) and Clinical Disease Activity Score (CDAI), Pain VAS, Lifestyle Factors Questionnaire, Health Assessment Questionnaire (HAQ), Modified Illness Perception Questionnaire (Modified IPQ-R), Euro-Quality of Life Questionnaire (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Work Instability Scale (RA-WIS), Functional Assessment Of Chronic Illness Therapy-Fatigue (FACIT-F) and Symptoms in Persons At Risk of Rheumatoid Arthritis (SPARRA) questionnaire. 3) The proportion of participants requiring DMARD therapy, and the time to commencing DMARD therapy, including oral or parenteral corticosteroids. 4) Progression of radiographic changes in X-rays of the hands and feet scored by van der Heijde Sharpe Modified Scores or using the Larsen score. 5) Changes in scores of synovitis and vascularity defined by high resolution ultrasonography and power Doppler over time. 6) Adverse events. The exploratory endpoints of this study are: 1) Changes in serum ACPA levels over time. 2) ACPA isotype and antigenic fine specificity over time. 3) Signatures of immune and inflammatory responses as defined through analysis of serum, peripheral blood cell subsets, peripheral blood RNA expression profiling and urine. ; Timepoint(s) of evaluation of this end point: Secondary endpoints will be evaluated every 3 months for up to 24 months The exploratory endpoints will be evaluated at the end of the study following analysis of the biological samples.

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Countries

Netherlands, United Kingdom

Contacts

Public ContactAndrew P. Cope, Chief Investigator

Academic Department of Rheumatology

andrew.cope@kcl.ac.uk00440207848 6901

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026