ELV001 for Active Rheumatoid Arthritis in Patients with Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition

What is this study about?

This clinical trial is studying rheumatoid arthritis, a long-lasting disease that causes pain, swelling, and stiffness in the joints. The study is testing ELV001, an oral capsule, as an add-on treatment together with usual care in people whose disease is still active despite treatment with methotrexate and tumor necrosis factor inhibition, a type of treatment that blocks a body substance involved in inflammation. The purpose of the study is to see whether ELV001 is safe and helpful for active rheumatoid arthritis.

People in the study are assigned by chance to receive different doses of ELV001 or placebo tablets. The study is double-blind, which means that the treatment given is not known to the participants or the study team during the study. Treatment is taken for a period of time, and the health of the joints and overall condition are checked during the study visits. Safety is also watched closely, including possible side effects and changes in heart tracing, blood tests, and vital signs.

The study is looking at whether ELV001 can improve signs and symptoms of active rheumatoid arthritis when added to standard treatment. It also compares different dose levels to see how they work and how well they are tolerated.

1 study treatment begins

You start the trial by taking elv001 as an oral capsule or by taking placebo tablets. The study is randomized, which means the treatment is assigned by chance.

You receive 125 mg of elv001 by mouth, or you receive placebo tablets that do not contain active medicine.

The study is double-blind, which means that the treatment assignment is not revealed during the study.

2 treatment period through week 12

You continue the assigned study treatment during the first 12 weeks of the trial.

During this period, the study checks how your arthritis changes from the start of treatment to week 12.

The study measures disease activity using DAS28-CRP. This is a score that shows how active the rheumatoid arthritis is, using joint findings and a blood test called CRP (C-reactive protein, a marker of inflammation).

3 safety and response checks during the study

During the trial, your safety is monitored by checking for side effects and other medical changes.

The study records the number and seriousness of treatment-emergent adverse events (teaes, meaning unwanted medical problems that appear after treatment starts), including serious ones.

The study also checks for adverse events of special interest (aesis, meaning side effects that are watched closely) and suspected unexpected serious adverse reactions (susars, meaning serious side effects that are not expected).

Your heart tracing may be checked with a 12-lead ecg (electrocardiogram, a test that records the heart’s electrical activity), including a measurement called qtcf.

Your vital signs are checked, such as blood pressure, pulse, and related basic body measurements.

Blood and urine tests are used to check laboratory parameters, including blood counts, blood chemistry, clotting tests, and urine findings.

4 week 12 assessment

At week 12, the study compares your condition with the start of treatment.

The study checks whether you have reached remission or low disease activity. Remission means the disease is very quiet. Low disease activity means the disease is still present but less active.

The study also checks how many people reach acr20, acr50, or acr70. These are levels of improvement in rheumatoid arthritis symptoms and signs.

The study measures changes in swollen joints, tender joints, the doctor’s overall rating of disease activity, blood crp levels, sdai (simplified disease activity index), and cdai (clinical disease activity index).

You complete questionnaires about your own disease activity, arthritis pain, physical function, general health, and fatigue. These include vas (visual analogue scale, a line-based rating scale), haq-di (health assessment questionnaire-disability index, a measure of daily function), sf-36 (a general health questionnaire), and the facit-fatigue questionnaire (a questionnaire about tiredness).

5 continued assessment through week 24

The study continues to follow your response through week 24.

At week 24, the same types of checks are repeated for disease activity, symptom improvement, and patient-reported outcomes.

The study again looks at remission, low disease activity, acr20, acr50, and acr70, as well as changes in joint counts, doctor ratings, blood crp, sdai, cdai, pain, function, general health, and fatigue.

6 drug level testing

The study measures plasma drug concentrations, which means the amount of study medicine in your blood.

These measurements include cmax (the highest level reached), tmax (the time needed to reach the highest level), auc0-last and auc0-inf (measures of total drug exposure over time), t½ (the time it takes for the amount of drug to fall by half), λz (a rate used to describe how the drug leaves the body), cl/f (apparent clearance), vz/f (apparent volume of distribution), and clr (renal clearance, meaning removal by the kidneys) after a single oral dose.

Who Can Join the Study?

Be able to read and write well enough to provide written informed consent, understand what the study asks, and follow the study rules.
Be currently taking methotrexate (MTX), a standard arthritis medicine, together with folic acid supplementation, according to local standard care.
Have taken methotrexate for at least 6 months, including at least 3 months at a stable dose without changes.
Take methotrexate within the allowed dose range: up to 25 mg per week by mouth or up to 20 mg per week by injection, with a minimum of 15 mg per week; if there was intolerance or side effects, doses of 7.5 mg per week or more are acceptable.
Be currently taking a TNF inhibitor (TNFi), a medicine that blocks tumor necrosis factor, for at least 6 months, including at least 3 months at a stable dose.
Have had a partial response to the TNF inhibitor, meaning the doctor believes the medicine helped some but did not fully control the arthritis, based on standard disease activity measures.
Be allowed to keep taking certain arthritis medicines during the study if the dose has been stable for at least 4 weeks before screening: hydroxychloroquine up to 400 mg per day, or prednisone 7.5 mg per day or less, or an equivalent dose of another corticosteroid.
Have used other arthritis medicines before the study only if they were stopped at least 2 months before screening; medicines that remove certain immune cells, such as rituximab, must have been stopped at least 12 months before screening.
Be 18 to 75 years old when signing the informed consent form.
Have a body mass index (BMI) between 18.5 and 32.0 kg/m², and weigh at least 50 kg at the screening visit. BMI is a measure that compares weight and height.
Have adult-onset rheumatoid arthritis and meet the 2010 ACR/EULAR criteria for at least 6 months before screening. These are standard doctor-used rules for confirming the diagnosis.
Have active arthritis at screening, shown by a DAS28-CRP score of 3.2 or higher. DAS28-CRP is a score that measures how active the arthritis is, using joint findings and a blood test called CRP.
Have at least 3 swollen joints and at least 3 tender joints at both screening and baseline. Swollen joints are joints with visible or felt swelling, and tender joints are joints that hurt when pressed. The distal interphalangeal joints may be checked but are not counted for eligibility.
Have a C-reactive protein (CRP) level above the upper limit of normal at screening. CRP is a blood test that can show inflammation.
Have acceptable blood counts at both screening and baseline, with repeat testing allowed for borderline results: neutrophils at least 2.5 × 10⁹/L, platelets at least 100 × 10⁹/L, hemoglobin at least 10.0 g/dL, lymphocytes above 500 cells/μL, and total white blood cells at least 3.0 × 10⁹/L.
Have acceptable liver and kidney function at screening, with repeat testing allowed for borderline results: creatinine, ALT, and AST no more than 2 times the upper limit of normal; bilirubin and alkaline phosphatase no more than 1.5 times the upper limit of normal; and eGFR greater than 60 mL/min/1.73 m². Creatinine, ALT, AST, bilirubin, and alkaline phosphatase are blood tests that help show how the kidneys and liver are working.
If female and able to become pregnant, have a negative blood pregnancy test at screening and a negative urine pregnancy test within 24 hours before the first dose.
If female and able to become pregnant, use highly effective contraception from the time of signing consent until at least 90 days after the last dose. Highly effective contraception means a method with a very low chance of pregnancy.
If female and able to become pregnant, not donate eggs (ova) from the time of signing consent until at least 90 days after the last dose.
If male, use condoms and make sure a partner who can become pregnant uses highly effective contraception until at least 90 days after the last dose.
If male, not donate sperm until at least 90 days after the last dose.

Who Cannot Join the Study?

Severe rheumatoid arthritis disability: if the arthritis is so severe that it is classified as Class IV on the Steinbrocker Functional classification, meaning the person is unable to do most self-care activities and is largely limited in movement.
Loss of response to TNF inhibitor treatment: if the current TNFi treatment no longer works because the body has made anti-drug antibodies (proteins made by the immune system that can block the medicine), as judged by the study doctor.
Recent medicine dose changes: if the dose of methotrexate (MTX) or TNFi was changed within the last 3 months before the study started, or if the dose of hydroxychloroquine or oral prednisolone was changed within the last 4 weeks before the study started.
Interstitial lung disease: if there is evidence of interstitial lung disease (ILD), which means scarring or inflammation in the lung tissue, based on medical history, symptoms, scans, or lung function tests, no matter what caused it.
High-dose steroids recently: if the person has taken more than 7.5 mg/day of oral prednisone or an equivalent steroid dose, or has had parenteral corticosteroids (steroids given by injection or infusion) within the last 4 weeks.
Joint steroid injections recently: if the person has had intra-articular corticosteroids (steroids injected directly into a joint) within the last 4 weeks.
Recent immune-suppressing arthritis medicines: if any other csDMARD, bDMARD, or immunosuppressive drug was used in the last 2 months. These are medicines that reduce immune system activity.
Recent cell-depleting therapy: if the person had cell depletion therapy, such as rituximab, within the last 12 months. This is a treatment that removes certain immune cells.
Problems absorbing medicine: if the person has a condition that could stop the body from absorbing the study drug properly, such as short bowel syndrome, which means part of the small intestine is missing or not working well.
Other serious medical problems: if the person has another important medical condition that could affect treatment or study safety, such as poorly controlled diabetes or high blood pressure, chronic kidney disease stage IIIb, IV, or V (moderate to severe kidney damage), symptomatic heart failure with NYHA class II, III, or IV (heart weakness causing symptoms with activity or even at rest), heart attack or unstable angina within the past 12 months, severe long-term lung disease needing oxygen, or another major long-term inflammatory or connective tissue disease other than rheumatoid arthritis.
Recent substance abuse: if there is a history of chronic alcohol abuse, IV drug abuse (drug use by vein), or illegal drug abuse within 1 year before screening.
Certain infections: if the person has HIV infection, current hepatitis B infection, current hepatitis C infection, or active tuberculosis (TB).
Cancer history: if the person has a current or past malignant disease (cancer), except for certain skin cancers called basal cell carcinoma or squamous cell carcinoma that were removed and have not spread for 3 years.
Recent or planned surgery: if the person had surgery within 12 weeks before screening, except for minor surgery done with little or no anesthesia and without complications, or if they have surgery planned during the study.
Recent live vaccines: if the person received a BCG vaccine or BCG treatment within 12 months, or any other live vaccine within 3 months, or plans to receive a live vaccine during the study. Live vaccines contain weakened germs.
Recent or ongoing infections: if the person had a serious infection, an opportunistic infection (an infection that happens more easily when the immune system is weak), a long-lasting infection, or a recurring infection within 3 months before screening, or before the randomization visit. This includes infections that needed hospital care or antibiotics given by injection or infusion. Some mild repeated infections, such as simple skin infection or common cold sores, may be allowed only if the study doctor thinks they do not increase risk.
Untreated latent tuberculosis: if the person has or had latent TB infection (LTBI) that was not treated with a full recommended course of therapy. Latent TB means the TB germ is in the body but not causing symptoms. People with fully treated latent TB may still join.
Too many previous advanced arthritis treatments: if the person has used more than 1 previous bDMARD or tsDMARD, not counting the current TNFi. These are advanced medicines that target the immune system. Switching between similar medicines for non-medical reasons counts as one treatment.
Recent infection or fever: if there is a current or recent active infection, meaning no clear signs or symptoms of infection and no needed anti-infection treatment completed within 30 days before the study start, or if the person has a fever of 100.5°F (38°C) or higher at screening or baseline.
Other serious problems: if there is any other severe or uncontrolled medical, surgical, mental health, or social problem that could affect safety, participation, or study results, as judged by the study doctor.
Recent use of another study drug: if the person used another investigational medicinal product (a medicine being tested in a study) within 12 weeks or within at least 5 half-lives, whichever is longer, before receiving the study drug.
Pregnancy or breastfeeding: if the woman is pregnant, breastfeeding, or planning to become pregnant during the study.
Abnormal heart rhythm or ECG findings: if the QTcF value on the heart tracing (ECG, a test that records the heart’s electrical activity) is above 450 ms for males or above 470 ms for females at screening or baseline, or if the ECG shows second- or third-degree atrioventricular block (a blockage in the heart’s electrical signal), bundle branch block, an arrhythmia (abnormal heart rhythm, except sinus arrhythmia or supraventricular premature beats), or if the QT interval cannot be read clearly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
University Multiprofile Hospital For Active Treatment Saint Georgi EAD	Plovdiv	Bulgaria
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria
Medical Plus s.r.o.	Uherske Hradiste	Czechia
University Multiprofile Hospital For Active Treatment Kaspela EOOD	Plovdiv	Bulgaria
Medical Center Teodora EOOD	Ruse	Bulgaria
Hospital Universitario 12 De Octubre	Madrid	Spain
Hospital Universitario Basurto	Bilbao	Spain
Hospital Universitario Lucus Augusti	Lugo	Spain
Rheuma Medicus Sp. z o.o.	Warsaw	Poland
Santa Sp. z o.o.	Lodz	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Reumed Sp. z o.o.	Lublin	Poland
Medyczne Centrum Hetmanska Piotr Leszczyński	Poznan	Poland
Malopolskie Badania Kliniczne Sp. z o.o.	Cracow	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Nova Reuma Domyslawska I Rusilowicz Lekarza Reumatologa I Fizjoterapeuty sp.p.	Bialystok	Poland
Twoja Przychodnia Poznańskie Centrum Medyczne Sp. z o.o.	Poznan	Poland
Mbal Lyulin EAD	Sofia	Bulgaria
Diagnostics And Consultation Center Convex Ltd.	Sofia	Bulgaria
Medical Center Artmed Ltd.	Plovdiv	Bulgaria
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
PV Medical Services s.r.o.	Zlin	Czechia
Békés Vármegyei Központi Kórház, Pándy-Kálmán Tagkórház	Gyula	Hungary
Debreceni Egyetem, Reumatológiai és Immunológiai Klinika	Debrecen	Hungary
Semmelweis Egyetem, Reumatológiai és Immunológiai Klinika	Budapest	Hungary
Diagnostic-Consultative Center XV Sofia EOOD	Sofia	Bulgaria
Multiprofile Hospital for Active Treatment Sartse I Mozak EAD	Pleven	Bulgaria
Pneiisq Kjztibc	Hodmezovasarhely	Hungary
Vzjqnfgo slxfrr	Moravska Ostrava A Privoz	Czechia
Fbxxondn nxplrmnyj Mvwxw a Hhomxtm	Prague	Czechia
Ssjnxwz Schs Dh Hqdsquzrzh	Barcelona	Spain
ctwiugu mccanfzk Mvpvvu sknk Gyccchc pltgodsn lyovsyor	Sosnowiec	Poland
Prgloax Sbs z ofmy	Katowice	Poland
Dohbwidtuy Cqmyaadhuo Csiltu 1 Vvsbpiytn Ekpb	Velingrad	Bulgaria
Mkgjzze Crqnxe Sonwxr Eyih	Vratsa	Bulgaria
Asdifcxye Uji	Amsterdam	The Netherlands
Meynncyp Sal z ocoz	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
Bulgaria	Not yet recruiting	10.03.2026
Czechia	Not yet recruiting	10.03.2026
Hungary	Not yet recruiting	10.03.2026
Poland	Not yet recruiting	10.03.2026
Spain	Not yet recruiting	10.03.2026
The Netherlands	Not yet recruiting	10.03.2026

Trial locations

ELV001 is an oral capsule being tested as an add-on treatment for people with active rheumatoid arthritis. In this trial, it is given together with standard treatment to see whether it can help reduce arthritis activity and improve symptoms in patients who have not responded well enough to methotrexate and tumor necrosis factor inhibitors. The study is also checking how safe it is and how well people tolerate it.

Investigated diseases:

Rheumatoid arthritis

Rheumatoid arthritis – Rheumatoid arthritis is a long-term disease in which the immune system attacks the lining of the joints, causing ongoing inflammation. It usually begins with pain, swelling, stiffness, and warmth in the affected joints, often in the hands and feet. Over time, the inflammation can come and go in flares or remain active for long periods. As it progresses, joints may become more damaged, less flexible, and harder to use.

Trial ID:

2025-524005-32-00

Protocol code:

ELV001-201

Trial Phase:

Therapeutic exploratory (Phase II)

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ELV001 for Active Rheumatoid Arthritis in Patients with Inadequate Response to Methotrexate and Tumor Necrosis Factor Inhibition

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?