Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis (SEQUENS-RA)

September 29, 2025 updated by: University Hospital, Montpellier

Efficacy of a Sequential Treatment Strategy in Rheumatoid Arthritis. A Randomized Controlled Trial With an Independent Efficacy Assessor.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
220

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged between 18 or above
  • Rheumatoid arthritis according to ACR-EULAR 2010 (American College of Rheumatology-European League Against Rheumatism)
  • ACPA positive
  • Under methotrexate or leflunomide treatment for at least 3 months
  • DAS28-CRP>3.2 under methotrexate or leflunomide calculated with CRP dated less than 7 days from baseline
  • Escape under synthetic background treatment defined by an elevation of C-reactive protein (CRP) (CRP> 5mg/L ) or Erythrocyte sedimentation rate (ESR) (for men: > age in years/2 ; for women: > age (+10) /2)) within the last 6 months before baseline
  • Targeted DMARDs (biological and targeted synthetic DMARDs) naïve
  • Indication for a TNF inhibitor

Exclusion Criteria:

  • Subject unable to read or/and write
  • Planned longer stay outside the region that prevents compliance with the visit plan
  • Subject unable to sign informed consent form
  • Subject not covered by public health insurance
  • Dementia
  • Fibromyalgia
  • Contra-indications to TNF inhibitor and/or Abatacept
  • Absence of tuberculosis screening in the previous 3 months before baseline
  • Patient with untreated active tuberculosis
  • Patient who cannot be followed during 48 weeks
  • Drug addiction, addiction to alcohol
  • Protected populations according to the French Public Health Code Articles L1121-5,6,8 (For example, pregnant, parturient or lactating women, prisoners, adults under guardianship or otherwise unable to consent).
  • Women of child bearing potential, unless they are using an effective method of birth control
  • Patient under law protection
  • Prisoners
  • Subject who are in a dependency or employment with the sponsor or the investigator
  • Participation in another interventional clinical trial or administration of an investigational product within the last 4 weeks before the screening date
  • Subject with moderate to severe heart failure (class 3 or class 4 cardiac disease as defined by the New York Heart Association Functional Classification)
  • Patients had a history of chronic obstructive pulmonary disease (COPD) and heavy smoking
  • Patients had a planned surgical procedure at least 30 days before the screening day
  • Known allergy or intolerance to an anti-TNF therapy
  • Hypersensitivity to the Abatacept or to any of its excipients
  • Patient with untreated active hepatitis B
  • Patient vaccinated with a live vaccine within 30 days prior to screening
  • Patients with an Inflammatory Bowel Disease (IBD) (loss of chance if switching from an anti-TNF to abatacept)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental

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)

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.

Drug: TNF Inhibitor (W0-W12)
All included patients will receive TNF inhibitors subcutaneous for 12 weeks.
Active Comparator: Control

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 (W0-W12)
All included patients will receive TNF inhibitors subcutaneous for 12 weeks.
Drug: TNF Inhibitor (W12-W48)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of patients in remission
Time Frame: 36 weeks following randomization

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.
36 weeks following randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
percentage of patients in remission at 12 weeks after randomization (DAS28-ESR)
Time Frame: At 24 weeks visit (corresponding to 12 weeks after randomization)

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.
At 24 weeks visit (corresponding to 12 weeks after randomization)
percentage of patients in remission at 12 weeks after randomization (CDAI)
Time Frame: At 24 weeks visit (corresponding to 12 weeks after randomization)

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.
At 24 weeks visit (corresponding to 12 weeks after randomization)
percentage of patients in remission at 12 weeks after randomization (SDAI)
Time Frame: At 24 weeks visit (corresponding to 12 weeks after randomization)

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
At 24 weeks visit (corresponding to 12 weeks after randomization)
percentage of patients in remission at 12 weeks after randomization (Boolean)
Time Frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
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
At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients in remission at 24 weeks after randomization (DAS28-ESR)
Time Frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission using definition : DAS28-ESR<2.6, at 24 weeks after randomization
At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission at24 weeks after randomization (CDAI)
Time Frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission using definition : CDAI≤2.8, at 24 weeks after randomization
At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission at 24 weeks after randomization (SDAI)
Time Frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission using definition : SDAI≤3.3, at 24 weeks after randomization
At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission at 24 weeks after randomization (Boolean)
Time Frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission using definitions : Boolean criteria, at 24 weeks after randomization
At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in remission at 36 weeks after randomization (DAS28-ESR)
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission using definition : DAS28-ESR<2.6, at 36 weeks after randomization
At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission at 36 weeks after randomization (CDAI)
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission using definition : CDAI≤2.8, at 36 weeks after randomization
At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission at 36 weeks after randomization (SDAI)
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission using definition : SDAI≤3.3, at 36 weeks after randomization
At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission at 36 weeks after randomization (Boolean)
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in remission using definition : Boolean criteria at 36 weeks after randomization
At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients with low disease activity at 12 weeks after randomization (DAS28-ESR)
Time Frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-ESR≤3.2, at 12 weeks after randomization:
At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients with low disease activity at 12 weeks after randomization (DAS28-CRP)
Time Frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-CRP≤3.2, at 12 weeks after randomization
At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients with low disease activity at 12 weeks after randomization (CDAI)
Time Frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients in low disease activity using definition : 2.8<CDAI≤10, at 12 weeks after randomization
At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients with low disease activity at 12 weeks after randomization (SDAI)
Time Frame: At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients in low disease activity using definition : 3.3<SDAI≤11, at 12 weeks after randomization
At 24 weeks visit (corresponding to 12 weeks after randomization)
Percentage of patients with low disease activity at 24 weeks after randomization (DAS28-ESR)
Time Frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in low disease activity using definition: 2.6≤DAS28-ESR≤3.2, at 24 weeks after randomization
At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients with low disease activity at 24 weeks after randomization (DAS28-CRP)
Time Frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-CRP≤3.2, at 24 weeks after randomization
At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients with low disease activity at 24 weeks after randomization (CDAI)
Time Frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in low disease activity using definition : 2.8<CDAI≤10, at 24 weeks after randomization
At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients with low disease activity at 24 weeks after randomization (SDAI)
Time Frame: At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients in low disease activity using definition : 3.3<SDAI≤11, at 24 weeks after randomization
At 36 weeks visit (corresponding to 24 weeks after randomization)
Percentage of patients with low disease activity at 36 weeks after randomization (DAS28-ESR)
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-ESR≤3.2, at 36 weeks after randomization
At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients with low disease activity at 36 weeks after randomization (DAS28-CRP)
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in low disease activity using definition : 2.6≤DAS28-CRP≤3.2, at 36 weeks after randomization
At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients with low disease activity at 36 weeks after randomization (CDAI)
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in low disease activity using definition : 2.8<CDAI≤10, at 36 weeks after randomization
At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients with low disease activity at 36 weeks after randomization (SDAI)
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients in low disease activity using definition : 3.3<SDAI≤11, at 36 weeks after randomization
At 48 weeks visit (corresponding to 36 weeks after randomization)
Proportion of responder patients at 12 weeks after randomization
Time Frame: At 24 weeks visit (corresponding to 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.
At 24 weeks visit (corresponding to 12 weeks after randomization)
Proportion of responder patients at 24 weeks after randomization
Time Frame: At 36 weeks visit (corresponding to 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.
At 36 weeks visit (corresponding to 24 weeks after randomization)
Proportion of responder patients at 36 weeks after randomization
Time Frame: At 48 weeks visit (corresponding to 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.
At 48 weeks visit (corresponding to 36 weeks after randomization)
Variations in the results of health assessment questionnaires administered to patients - HAQ-DI
Time Frame: Between baseline and 48 weeks

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).
Between baseline and 48 weeks
Variations in the results of health assessment questionnaires administered to patients - EQ5D
Time Frame: Between baseline and 48 weeks

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.
Between baseline and 48 weeks
Variations in the results of health assessment questionnaires administered to patients - SF-36
Time Frame: Between baseline and 48 weeks

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
Between baseline and 48 weeks
Variation in autoantibody titers (RF)
Time Frame: between baseline and 48 weeks
Variation of auto-antibodies titles (RF (rheumatoid factor)) and correlation of these variations with remission rate defined by DAS28-CRP<2.6.
between baseline and 48 weeks
Variation in autoantibody titers (ACPA)
Time Frame: between baseline and 48 weeks
Variation of auto-antibodies titles (ACPA (Anti Citrullinated Peptides Antibodies)) and correlation of these variations with remission rate defined by DAS28-CRP<2.6.
between baseline and 48 weeks
Frequency of flares
Time Frame: between baseline and 48 weeks

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.
between baseline and 48 weeks
Cumulative doses of steroids consumed
Time Frame: between baseline and 48 weeks
Cumulative doses of steroids collected with a booklet between baseline and 48 weeks
between baseline and 48 weeks
Percentage of Serious Adverse Events Occurring
Time Frame: between baseline and 48 weeks
Safety: rates of serious adverse events including severe infections between baseline and 48 weeks
between baseline and 48 weeks
Variation of medical costs on Quality Adjusted Life Year
Time Frame: between baseline and 48 weeks
Cost efficacy analysis based on direct and indirect costs and QALY (Quality Adjusted Life Year) between baseline and 48 weeks.
between baseline and 48 weeks
Variation of Sharp's score
Time Frame: between baseline and 48 weeks

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.
between baseline and 48 weeks
Percentage of patients remaining on abatacept
Time Frame: At 48 weeks visit (corresponding to 36 weeks after randomization)
Percentage of patients remaining on abatacept in the sequential arm and on the 1st TNF inhibitor in the control arm at 48 weeks
At 48 weeks visit (corresponding to 36 weeks after randomization)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jacques MOREL, MD-PhD, UF of Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2022

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RECHMPL21_0568

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Abatacept (W12-W48)

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