A Phase 3 interventional study of Abatacept (W12-W48) and TNF Inhibitor (W12-W48) in Rheumatoid Arthritis, sponsored by University Hospital, Montpellier. Recruiting at 17 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by University Hospital, Montpellier · Phase 3, Interventional, and Treatment
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological DMARD (TNF inhibitors, anti-Interleukin 6 (anti-IL6)), abatacept, or rituximab) or a targeted synthetic (ts) DMARD (JAK inhibitors) is considered.
Current practice is to start a bDMARD (biologic Disease Modifying Antirheumatic Drugs) and especially TNF inhibitors (etanercept or monoclonal anti-TNF antibodies) with the benefit of hindsight. However, abatacept and TNF inhibitors have demonstrated similar efficacy in patients with insufficient response to csDMARD (AMPLE trial).
Although abatacept has shown a very good tolerance profile that might be superior to other bDMARDs rheumatologists might be reluctant to use it as a first line bDMARD as there is a belief of a slower efficacy compared to other bDMARDs or JAK inhibitors. Indeed, in real world study, compared to TNF inhibitors it seems that discontinuation of abatacept is more related to lack of effectiveness than safety issues.
Investigators have hypothesized that first rapidly controlling the inflammation phase, using TNF inhibitors followed by abatacept to induce an immunological remission would optimize response and tolerance of ACPA positive patients with RA. To demonstrate our hypothesis, the investigaors propose a randomized controlled trial with one arm receiving an induction therapy for 12 weeks with a TNF inhibitor followed by a cell-targeted bDMARD (abatacept) and the other arm, receiving TNF inhibitors.
In rheumatoid arthritis (RA), the consensual 1st line conventional synthetic disease modifying antirheumatic drugs (csDMARD) of RA is methotrexate (MTX) (1). In case of contra-indication or intolerance to MTX, leflunomide is an alternative. If the treatment target is not achieved with csDMARD strategy, addition of a biological (b) DMARD (TNF inhibitors, anti-IL6, abatacept, or rituximab) or a targeted synthetic (ts) DMARD (JAK inhibitors) is considered.
Current practice is to start a bDMARD and especially TNF inhibitors (etanercept or monoclonal anti-TNF antibodies) with the benefit of hindsight. However, abatacept and TNF inhibitors have demonstrated similar efficacy in patients with insufficient response to csDMARD (AMPLE trial).
Although abatacept has shown a very good tolerance profile that might be superior to other bDMARDs rheumatologists might be reluctant to use it as a first line bDMARD as there is a belief of a slower efficacy compared to other bDMARDs or JAK inhibitors. Indeed, in real world study, compared to TNF inhibitors it seems that discontinuation of abatacept is more related to lack of effectiveness than safety issues.
This is the first study to propose a therapeutic sequential strategy with an induction therapy using a TNF inhibitor for 12 weeks to control inflammation followed by a cell-targeted biological DMARD targeting T cells (abatacept) in order to decrease auto-antibodies (rheumatoid factor and/or ACPA).
Presence of auto-antibodies (ACPA/RF) are predictive of better response to cell- targeted DMARDs.
In early AMPLE trial, RA patients ACPA+ with insufficient response to MTX were treated with abatacept or adalimumab. DAS28-CRP remission rates were 55% in abatacept group and 30% in adalimumab group.
Patients carrying the shared epitope (HLA-DR (Human Leucocyte Antigen-DR) alleles associated with RA), were also more likely to reach remission (DAS28-CRP\<2.6) with abatacept (50%) than adalimumab (23%) at 24 weeks.
The clinical trial offered by investigateors here could change the paradigm in the strategy used in RA supporting the importance to first control inflammation environment in order to allow the cell-targeted bDMARDs to control immunological process which has been recently associated with a higher percentage of clinical remission.
To compare the percentage of remission (DAS28-CRP\<2.6) obtained during the 36 weeks following randomization, with a sequential therapeutic strategy using abatacept versus a routine strategy continuing TNF inhibitors (TNFi), in ACPA positive RA patients responding to a first TNFi, initiated 12 weeks before randomization.
The primary endpoint will be analyzed with a generalized estimating equations (GEE) model for repeated data.
It is a multicentric, open label, randomized controlled trial comparing two different strategies of treatment with an independent efficacy assessor. For this clinical trial, to limit response bias, bDMARDs with a similar mode of administration (subcutaneous) are proposed.
In the experimental arm, a therapeutic sequential strategy will be proposed and in the control arm TNF inhibitors will be proposed for 48 weeks. All included patients will receive TNF inhibitors subcutaneous for 12 weeks. At 12 weeks (W12), patients who have at least a moderate EULAR response (delta DAS28-CRP between W0 and W12>0.6 and DAS28-CRP≤5.1 at W12) will be randomized with a 1:1 ratio in the sequential strategy arm or the control arm. In the sequential strategy arm, the 88 randomized RA patients will be switched to abatacept subcutaneous for 36 weeks. Patients who will withdraw abatacept during the follow-up will be considered as a failure.
In the control group, the 88 randomized RA patients will be treated with TNF inhibitor subcutaneous for another 36 weeks. In case of insufficient response to a first TNF inhibitor at 24 or 36 weeks, a second TNF inhibitor will be proposed. Anti-TNF drugs withdrawal will be considered as a failure. Steroids 0.1mg/kg/ day will be allowed but at stable dose 2 weeks before and with guided step-down strategy targeting withdrawal before 24 weeks following randomization. Clinical evaluation of disease activity using different scores (DAS28-ESR, CDAI, SDAI, Boolean criteria) and tolerance will be performed at all visits.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 220 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All included patients will receive TNF inhibitors subcutaneous for 12 weeks. In the experimental arm, a therapeutic sequential strategy will be proposed from W12 visit. At 12 weeks (W12), patients who have at least a moderate EULAR response (delta DAS28-CRP between W0 and W12\>0.6 and DAS28-CRP≤5.1 at W12) will be randomized with a 1:1 ratio in the sequential strategy arm or the control arm. In the sequential strategy (experimental) arm, the 88 randomized RA patients will be switched to abatacept subcutaneous for 36 weeks.
Drug: Abatacept (W12-W48) · Drug: TNF Inhibitor (W0-W12)
All included patients will receive TNF inhibitors subcutaneous for 12 weeks. In the control group, the 88 randomized RA patients will be treated with TNF inhibitor subcutaneous for another 36 weeks (from W12 visit). In case of insufficient response to a first TNF inhibitor at 24 or 36 weeks, a second TNF inhibitor will be proposed.
Drug: TNF Inhibitor (W12-W48) · Drug: TNF Inhibitor (W0-W12)
The experimental strategy will evaluate abatacept 125 mg/week following 12 weeks of anti-TNF prescribed in usual care. Concomitant treatment with stable doses of csDMARD, non-steroidal anti-inflammatory drugs, analgesic agents, glucocorticoids (≤10 mg of prednisone or the equivalent per day), or a combination of these drugs will be permitted. Patients will continue to take methotrexate or leflunomide for the duration of the study.
In the control group, the 88 randomized RA patients will be treated with TNF inhibitor subcutaneous for 36 weeks. In case of insufficient response to a first TNF inhibitor at 24 or 36 weeks, a second TNF inhibitor will be proposed.
All included patients will receive TNF inhibitors subcutaneous for 12 weeks.
Percentage of patients in remission
Percentage of patients in remission defined by DAS28-CRP\<2.6 score during the 36 weeks following randomization. Disease Activity Score-28 with C-Reactive Protein (DAS28-CRP) describes severity of rheumatoid arthritis using clinical and laboratory data, specifically CRP. It includes 4 variables (number of painful joints out of 28 joints, number of swollen joints out of 28 joints, global assessment of the disease by the patient on a Visual Analogue Scale (VAS), markers of inflammation : CRP) A DAS28-CRP score \> 5.1 means high disease activity, DAS28-CRP \< or = 3.2 indicates low disease activity, a DAS28-CRP \< 2.6 indicates disease remission.
Time frame: 36 weeks following randomization
percentage of patients in remission at 12 weeks after randomization (DAS28-ESR)
Percentage of patients in remission using definition : DAS28-ESR\<2.6, at 12 weeks after randomization Disease Activity Score-28 with Erythrocyte Sedimentation Rate (DAS28-ESR) describes severity of rheumatoid arthritis using clinical and laboratory data, specifically ESR.
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
percentage of patients in remission at 12 weeks after randomization (CDAI)
Percentage of patients in remission using definition : CDAI≤2.8, at 12 weeks after randomization Clinical Disease Activity Index (CDAI) is a useful clinical composite score. It's the sum of 4 parameters : Swollen 28-Joint + Tender 28-Joint Count + Patient Global disease Activity + Evaluator's Global disease Activity. Remission is defined as an CDAI of ≤2.8, low disease activity as \>2.8 and ≤10, moderate disease activity as \>10 and ≤22 and high disease activity as \>22.
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
percentage of patients in remission at 12 weeks after randomization (SDAI)
Percentage of patients in remission using definition : SDAI≤3.3, at 12 weeks after randomization Score Disease Activity Index (SDAI) is the sum of 5 parameters: the number of painful joints and synovitis (28 joints are tested) the global assessment of the patient and the therapist on a visual
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
percentage of patients in remission at 12 weeks after randomization (Boolean)
Percentage of patients in remission using definition: Boolean criteria, at 12 weeks after randomization Boolean criteria of remission are : number of tender and swollen joint, visual analogue scale for global health and CRP all ≤1
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients in remission at 24 weeks after randomization (DAS28-ESR)
Percentage of patients in remission using definition : DAS28-ESR\<2.6, at 24 weeks after randomization
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission at24 weeks after randomization (CDAI)
Percentage of patients in remission using definition : CDAI≤2.8, at 24 weeks after randomization
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission at 24 weeks after randomization (SDAI)
Percentage of patients in remission using definition : SDAI≤3.3, at 24 weeks after randomization
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission at 24 weeks after randomization (Boolean)
Percentage of patients in remission using definitions : Boolean criteria, at 24 weeks after randomization
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission at 36 weeks after randomization (DAS28-ESR)
Percentage of patients in remission using definition : DAS28-ESR\<2.6, at 36 weeks after randomization
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission at 36 weeks after randomization (CDAI)
Percentage of patients in remission using definition : CDAI≤2.8, at 36 weeks after randomization
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission at 36 weeks after randomization (SDAI)
Percentage of patients in remission using definition : SDAI≤3.3, at 36 weeks after randomization
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission at 36 weeks after randomization (Boolean)
Percentage of patients in remission using definition : Boolean criteria at 36 weeks after randomization
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients with low disease activity at 12 weeks after randomization (DAS28-ESR)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-ESR≤3.2, at 12 weeks after randomization:
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients with low disease activity at 12 weeks after randomization (DAS28-CRP)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-CRP≤3.2, at 12 weeks after randomization
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients with low disease activity at 12 weeks after randomization (CDAI)
Percentage of patients in low disease activity using definition : 2.8\<CDAI≤10, at 12 weeks after randomization
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients with low disease activity at 12 weeks after randomization (SDAI)
Percentage of patients in low disease activity using definition : 3.3\<SDAI≤11, at 12 weeks after randomization
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients with low disease activity at 24 weeks after randomization (DAS28-ESR)
Percentage of patients in low disease activity using definition: 2.6≤DAS28-ESR≤3.2, at 24 weeks after randomization
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients with low disease activity at 24 weeks after randomization (DAS28-CRP)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-CRP≤3.2, at 24 weeks after randomization
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients with low disease activity at 24 weeks after randomization (CDAI)
Percentage of patients in low disease activity using definition : 2.8\<CDAI≤10, at 24 weeks after randomization
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients with low disease activity at 24 weeks after randomization (SDAI)
Percentage of patients in low disease activity using definition : 3.3\<SDAI≤11, at 24 weeks after randomization
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients with low disease activity at 36 weeks after randomization (DAS28-ESR)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-ESR≤3.2, at 36 weeks after randomization
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients with low disease activity at 36 weeks after randomization (DAS28-CRP)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-CRP≤3.2, at 36 weeks after randomization
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients with low disease activity at 36 weeks after randomization (CDAI)
Percentage of patients in low disease activity using definition : 2.8\<CDAI≤10, at 36 weeks after randomization
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients with low disease activity at 36 weeks after randomization (SDAI)
Percentage of patients in low disease activity using definition : 3.3\<SDAI≤11, at 36 weeks after randomization
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Proportion of responder patients at 12 weeks after randomization
Proportion of responders using EULAR (European Alliance of Associations for Rheumatology) definition (variations of DAS28-CRP from baseline \>0.6 and DAS28-CRP≤5.1) at 12 weeks after randomization.
Time frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Proportion of responder patients at 24 weeks after randomization
Proportion of responders using EULAR definition (variations of DAS28-CRP from baseline \>0.6 and DAS28-CRP≤5.1) at 24 weeks after randomization.
Time frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Proportion of responder patients at 36 weeks after randomization
Proportion of responders using EULAR definition (variations of DAS28-CRP from baseline \>0.6 and DAS28-CRP≤5.1) at 36 weeks after randomization.
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Variations in the results of health assessment questionnaires administered to patients - HAQ-DI
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire (HAQ-DI) The Health Assessment Questionnaire Disability Index (HAQ-DI) is an assessment of functional impairment. There are 8 sections: dressing, arising, eating, walking, hygiene, reach, grip, and activities. Scoring within each section is from 0 (without any difficulty) to 3 (unable to do).
Time frame: Between baseline and 48 weeks
Variations in the results of health assessment questionnaires administered to patients - EQ5D
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire EQ5D The EuroQol 5-dimensional descriptive system (EQ5D) is a Health Assessment Scale quality of life questionnaire evaluating: mobility, washing and dressing, daily activities, pain and anxiety. Each question has 3 levels of answers: No problem, some problems and important problems.
Time frame: Between baseline and 48 weeks
Variations in the results of health assessment questionnaires administered to patients - SF-36
Values and variations from baseline of patient-reported outcomes including health assessment questionnaire SF-36 The Medical Outcomes Study 36-item Short-Form Health Survey (SF-36) is a patient-operated, self-administered measure created to assess health-related quality of life
Time frame: Between baseline and 48 weeks
Variation in autoantibody titers (RF)
Variation of auto-antibodies titles (RF (rheumatoid factor)) and correlation of these variations with remission rate defined by DAS28-CRP\<2.6.
Time frame: between baseline and 48 weeks
Variation in autoantibody titers (ACPA)
Variation of auto-antibodies titles (ACPA (Anti Citrullinated Peptides Antibodies)) and correlation of these variations with remission rate defined by DAS28-CRP\<2.6.
Time frame: between baseline and 48 weeks
Frequency of flares
Frequency of flares assessed using the FLARE questionnaire completed by the patient between visits The self-administered Flare Assessment in Rheumatoid Arthritis (FLARE) is a self-administered questionnaire that was developed to help identify patients who had flare in the interval between 2 rheumatology consultations.
Time frame: between baseline and 48 weeks
Cumulative doses of steroids consumed
Cumulative doses of steroids collected with a booklet between baseline and 48 weeks
Time frame: between baseline and 48 weeks
Percentage of Serious Adverse Events Occurring
Safety: rates of serious adverse events including severe infections between baseline and 48 weeks
Time frame: between baseline and 48 weeks
Variation of medical costs on Quality Adjusted Life Year
Cost efficacy analysis based on direct and indirect costs and QALY (Quality Adjusted Life Year) between baseline and 48 weeks.
Time frame: between baseline and 48 weeks
Variation of Sharp's score
Variations Sharp's score between baseline and 48 weeks The Sharp method for scoring radiographs of hands and feet in rheumatoid arthritis. The method includes, in each hand, 16 areas for erosions and 15 areas for joint space narrowing, and, in each foot, 6 areas for erosions and 6 areas for joint space narrowing. The maximal erosion score for each hand is thus 80, considering the 16 areas for erosions per hand. Maximal total narrowing/(sub)luxation score in the hands is 120. Maximal total erosion score (hands and feet) is 280. Maximal total narrowing/(sub)luxation score in the feet is 48. Maximal total narrowing/(sub)luxation score (hands and feet) is 168. Maximal total Sharp score is 448. Sharp score will be calculated at W0 (baseline) and W48 (last visit). Variation of Shard score= score at W48- score at W0.
Time frame: between baseline and 48 weeks
Percentage of patients remaining on abatacept
Percentage of patients remaining on abatacept in the sequential arm and on the 1st TNF inhibitor in the control arm at 48 weeks
Time frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Plan to share: Undecided
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Studies of the drug tested here: Abatacept
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