Prediction Medical Device for Rheumatoid Arthritis (PREDIRA)

San Carlos Clinical Hospital

Status: Unknown

Conditions: Arthritis, Rheumatoid

Treatments: Other: Biotherapy prescription without SinnoTest® software; Device: SinnoTest®

Study type: Interventional

Funder types: Other

Identifiers

NCT04147026

EUR.PREDIRA

Details and patient eligibility

About

Rheumatoid arthritis (RA) is one of the leading chronic inflammatory rheumatism, with a prevalence of about 0.4% of the population.

First-line therapy with synthetic disease modifying anti-rheumatic drugs (including methotrexate) is insufficiently effective in 40% of cases. These patients are then treated with biotherapies. The use of these bio-drugs increases each year, becoming a public health issue and a considerable economic burden. Besides, their growth is just beginning, as they are among the major purveyors of pharmacy innovations.

There are about ten bio-drugs currently on the market for rheumatoid arthritis with an average annual treatment cost of 8 to 12 K € per patient. This cost is 20 times higher than that of synthetic disease modifying anti-rheumatic drugs. However, among patients treated with biotherapies, clinical practice shows that about one-third will not respond to the selected drug. In the case of non-response, practitioners currently have no choice but to perform an empirical rotation between the different treatments, because no tool capable of predicting the response or non-response to these molecules is currently available.

The study is a prospective, phase III, controlled, multicenter, and randomized, single-blind (patient) clinical trial.

• Intervention arm: Prescription of biotherapy (rituximab, adalimumab, abatacept) using SinnoTest® software
• Control arm: Prescription of biotherapy without the SinnoTest® software which corresponds to current practice (all biotherapies).

In addition, a sub study will be carried out within this trial to analyse the proteomic profile of the patients included and their modification throughout the study.

To study the clinical and pharmacoeconomic impact after 6 months of the use of the SinnoTest® predictive tool in patients with rheumatoid arthritis who have failed to a first anti-TNF biologic agent compared to usual care.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years old and under 70 years old,
• Patients with RA, defined according to the ACR / EULAR 2010 or ACR 1987 criteria,
• Patients failing a first anti-TNF, defined as:
• Ineffectiveness (which is defined as a DAS28-ESR ≥3.2 and an inadequate response to iTNF according to the usual rheumatologist, which generally includes one or more of the following conditions: persistent swollen and tender joints, persistence of disease activity according to the overall evaluation of the patient, high levels of acute phase reactants and/or dependence of analgesics, nonsteroidal anti-inflammatory drugs or corticosteroids); or
• Toxicity(defined as the appearance of any adverse event that the patient's rheumatologist relates to the medication and requires discontinuation),
• Effective contraception for patients of childbearing potential (oral contraceptive, intrauterine device, implant, spermicide, surgical sterilization or abstinence),
• Patients able to read and understand the modalities of the protocol,
• Patients who have dated and signed the informed consent form of the trial,
• Stability of treatments (no change) between the selection visit and the inclusion visit (M0).

Exclusion criteria

• Patients with a contraindication to any bDMARD or methotrexate,
• Patients included in another therapeutic evaluation study during this trial,
• Surgical intervention programmed during the trial,
• Patients with difficulties in understanding the Spanish language,
• Patients cannot be followed up 6 months,
• Psychosocial instability incompatible with regular monitoring (homelessness, addictive behaviour, antecedent of psychiatric pathology or any other comorbidity that would make it impossible for free and informed consent or limit adherence to the protocol),
• Breastfeeding and/or pregnancy. Although there are bDMARD that can be used in pregnancy, since SinnoTest can recommend one that discourages this condition, it is decided to exclude the inclusion of pregnant women.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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180 participants in 2 patient groups

SinnoTest® software

Experimental group

Description:

SinnoTest® is a therapeutic guidance device for patients suffering from rheumatoid arthritis. Prescription of an original or biosimilar biotherapy (rituximab, adalimumab, abatacept) is possible.

Treatment:

Device: SinnoTest®

Current practice

Active Comparator group

Description:

Prescription of biotherapy without the SinnoTest® software which corresponds to current practice (all biotherapies).

Treatment:

Other: Biotherapy prescription without SinnoTest® software