Double-Drug attack on rheumatoid arthritis shows promise in new trial

NCT ID NCT04870203

Disease control Sponsor: University Hospital, Bordeaux Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase III trial tests whether combining baricitinib with an anti-TNF drug (adalimumab or etanercept) works better than baricitinib alone for people with rheumatoid arthritis who haven't responded to prior treatments. The study involves 160 adults aged 18-65 with active disease. Researchers will measure how many patients achieve a 50% improvement in symptoms (ACR50) and track side effects over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: baricitinib and anti-TNF drugs (adalimumab or etanercept)
What this could lead to: If successful, this combination could offer a more effective treatment option for people with rheumatoid arthritis who haven't responded well to other therapies.
What could go wrong: This is a relatively small Phase III trial (160 participants). Combining these drugs may increase the risk of serious side effects, and the benefit may be modest.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

160 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female; * Age between 18 and 65 years-old; * Adult patient with a diagnosis of RA as defined by the ACR/EULAR 2010 criteria for the classification of RA; * Patient who presents an inadequate response to at least one bDMARD or tsDMARD for at least 12 weeks prior to study entry at a dose that is considered acceptable to assess clinical response adequately; * Patient affected by active RA (DAS28-ESR \> 3.2 or sDAI \> 11 or cDAI \> 10) eligible to receive a bDMARD or tsDMARD according to the French Society of Rheumatology guidelines; * Patient treated by prednisone dosage ≤ 10mg per day. The corticosteroids dosage will be decreased to 7,5 mg/day at the beginning of the study (W0); * Person affiliated with or beneficiary of the French social security scheme; * Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any examination required by the research project). Exclusion Criteria: * Patient previously treated with baricitinib; * Patient previously treated by both adalimumab and etanercept. If the patient received previously only one of these two treatments, he/she can be included in the study with the treatment he/she has not yet received (if he/she is randomized in the experimental COMBI group); * Patient affected by another form of inflammatory arthritis with the exception of secondary Sjögren syndrome; * Patient who presents contraindications to the study treatments; * Patients who is an active smoker or former smokers with a maximum exposure of 10 years; * Patient who is currently receiving glucocorticosteroids at doses \>10 mg of prednisone per day (or equivalent) or has been receiving an unstable dosing regimen of corticosteroids within 4 weeks of study entry; * Patient who is currently receiving more than 1 concomitant csDMARD (MTX, leflunomide, hydroxychloroquine or sulfasalazine) at the time of study entry; * Patient who is currently receiving or has received csDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX (up to 25 mg/week), leflunomide (up to 20 mg/day), hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 4 weeks prior to study entry. * Doses of hydroxychloroquine or sulfasalazine should be stable for at least 4 weeks prior to study entry; if either has been recently discontinued, the patient must not have taken any dose within 4 weeks prior to study entry. * Immunosuppression related to organ transplantation is not permitted; * Patient who has received any parenteral corticosteroid administered by intramuscular or intravenous injection within 4 weeks prior to study entry, or is anticipated to require parenteral injection of corticosteroids during the study; * Patient who had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 4 weeks prior to study entry. Joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization cannot be counted in the TJC and SJC for entry or enrollment purposes; * Patient with haemoglobin less than 80 g/L, absolute lymphocyte count lower than 0.5×109/L, absolute neutrophil count less than 1×109/L, or platelet count less than 100×109/L; clearance creatinine less than 60 mL/min; total bilirubin more than 1.5 times the upper limit of normal (ULN) at screening, aspartate aminotransferase, or alanine amino-transferase more than 2 times the upper limit of normal (ULN) at screening. * Patient with co-administration with OAT3 inhibitors (such as probenecid); * Patient who has a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric diseases or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data; * Patient with an history of Moderate to severe heart failure (NYHA classes III/IV); * Patient with an history of Major Adverse Cardiovascular Events (non-fatal myocardial infarction or non-fatal stroke); * Patient who has a history of Venous Thromboembolic Event (VTE) (DVT/PE) within 12 weeks prior to randomization or have a history of recurrent (\>1) VTE (DVT/PE). Prior DVT with PE where events overlapped in time (i.e., with PE considered resulting from DVT) is not considered recurrent DVT/PE for the purpose of this criterion. * Patient who has been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination). Investigators should review the vaccination status of their patients and follow the local guidelines for adult vaccination with nonlive vaccines intended to prevent infectious disease prior to entering patients into the study; * Patient with an active cancer; * Patient with malignancy or history of malignancy; * Patient who has a current or recent (\<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection; * Patient who is immunocompromised and, in the opinion of the investigator, is at an unacceptable risk for participating in the study; * Patient with a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV); * Patient who had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB; * Patient who has evidence of active TB or has previously had evidence of active TB and did not receive appropriate and documented treatment; * Patient who has evidence of latent TB (as documented by a positive Purified Protein Derivative (PPD), no clinical symptoms consistent with active TB, and a normal chest x-ray at screening) unless patient completes at least 3 weeks of appropriate treatment prior to study entry and agrees to complete the remainder of treatment while in the trial * Patient who had any major surgery within 8 weeks prior to study entry or will require major surgery during the study that, in the opinion of the investigator, would pose an unacceptable risk to the patient; * Pregnant or breastfeeding woman, or woman who refuses to use an effective contraception during the study course; * Patient governed by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rheumatoid arthritis

Contacts and locations

Locations

AP-HM - service de rhumatologie

Marseille, France
AP-HP - Hopital Avicenne - service de rhumatologie

Bobigny, France
AP-HP - Hôpital Bichat - service de rhumatologie

Paris, France
AP-HP - Hôpital Cochin - service de rhumatologie

Paris, France
AP-HP - Hôpital Kremlin-Bicêtre - service de rhumatologie

Le Kremlin-Bicêtre, France
AP-HP - Hôpital La Pitié-Salpetrière - service de rhumatologie

Paris, France
AP-HP - Hôpital Saint-Antoine - service de rhumatologie

Paris, France
CH Emile Roux - service rhumatologie

Le Puy-en-Velay, France
CH de Belfort - service de rhumatologie

Belfort, France
CH de Dax - service de rhumatologie

Dax, France
CH de Niort - service de rhumatologie

Niort, France
CH de Pau - service de rhumatologie

Pau, France
CH de Reims - service de rhumatologie

Reims, France
CH de Saint-Malo - service de rhumatologie

St-Malo, France
CH de la Côte Basque - service de rhumatologie

Bayonne, France
CH du Mans - service de rhumatologie

Le Mans, France
CHD VENDEE - service de rhumatologie

La Roche-sur-Yon, France
CHRU de Nancy - service de rhumatologie

Vandœuvre-lès-Nancy, France
CHRU de Strasbourg - service de rhumatologie

Strasbourg, France
CHRU du Tours - service de rhumtologie

Tours, France
CHU de Bordeaux - service de rhumatologie

Bordeaux, France
CHU de Brest - Service de rhumatologie

Brest, France
CHU de Clermont-Ferrand - service de rhumatologie

Clermont-Ferrand, France
CHU de Montpellier - service de rhumatologie

Montpellier, France
CHU de Nice - service de rhumatologie

Nice, France
CHU de Nîmes - service de rhumatologie

Nîmes, France
CHU de Saint-Etienne- service de rhumatologie

Saint-Etienne, France
CHU de Toulouse - service de rhumatologie

Toulouse, France
Clinique de l'Infirmerie - service de rhumatologie

Caluire-et-Cuire, France
Groupement des Hôpitaux de l'Institut Catholique de Lille - service de rhumatologie

Lomme, France
Hopital NOVO - service de rhumatologie

Pontoise, France
Hospices Civils de Lyon - service de rhumatologie

Pierre-Bénite, France
Hôpital Saint-Joseph - service de rhumatologie

Marseille, France
Nouvel Hôpital Orléans La Source - service de rhumatologie

Orléans, France
Polyclinique de Limoges - service de rhumatologie

Limoges, France
service de Rhumatologie - CH Princesse Grace

Monaco, Monaco

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