A study testing RO7790121 for moderate to severe rheumatoid arthritis in patients who did not respond to or cannot tolerate TNF or JAK inhibitor treatments

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What is this study about?

This study is looking at rheumatoid arthritis that is moderate to severe. Rheumatoid arthritis is a long-term condition where the body’s defense system mistakenly attacks the joints, causing pain, swelling, and stiffness. The study will test a medication called RO7790121, which will be compared to placebo. This medication is given as an injection under the skin. Some people in the study will receive the actual medication while others will receive placebo. The people taking part will have rheumatoid arthritis that has not improved enough with previous treatments or they could not tolerate medicines called TNF inhibitors or JAK inhibitors.

The purpose of the study is to see if RO7790121 works better than placebo in reducing the activity of rheumatoid arthritis. The study will measure this by looking at changes in disease activity using a scoring system that includes C-reactive protein, which is a substance in the blood that shows inflammation levels. The main measurement will be taken at week 14 of the study.

During the study, participants will receive treatment and will be checked regularly to see how their rheumatoid arthritis is responding. The doctors will count how many joints are swollen and tender, and they will measure disease activity using different scoring methods. The study will also look at whether the treatment is safe by watching for any unwanted effects and checking blood tests and other health measurements. Blood samples will be taken at certain times to measure the amount of RO7790121 in the body.

1 Treatment period begins

Upon joining the study, you will be assigned to receive either RO7790121 or a placebo. A placebo is an inactive substance that looks like the real medication but contains no active ingredient.

The study is double-blind, which means neither you nor your doctor will know which treatment you are receiving during the study.

The medication will be administered as a subcutaneous injection, meaning it will be injected under the skin.

2 Regular treatment administration

You will receive injections of either RO7790121 or placebo at scheduled intervals throughout the study.

The exact dosage, frequency, and duration of injections will be determined according to the study protocol.

You will need to attend scheduled visits to receive the injections and for monitoring purposes.

3 Assessment at week 14

At week 14, your disease activity will be assessed using several measurement tools.

Your doctor will evaluate the Disease Activity Score-28 based on C-Reactive Protein levels. This score measures how active your rheumatoid arthritis is by looking at the number of swollen and tender joints, along with a blood test that measures inflammation.

The number of swollen and tender joints will be counted to determine your response to treatment.

Additional assessments will include measurements of joint inflammation and overall disease activity.

4 Ongoing monitoring and assessments

Throughout the study, you will be monitored for any side effects or adverse reactions to the treatment.

Regular blood tests and other laboratory tests will be performed to check for any changes in your health.

Your vital signs, such as blood pressure and heart rate, will be measured at scheduled visits.

You will be asked to complete questionnaires about your quality of life and how you are feeling, including the SF-36 questionnaire, which assesses your physical and mental health.

5 Additional response evaluations

Your response to treatment will be evaluated using ACR response criteria. ACR stands for American College of Rheumatology, and these criteria measure improvement in your symptoms.

ACR20, ACR50, and ACR70 responses will be assessed at week 14. These numbers represent 20%, 50%, and 70% improvement in your symptoms, respectively.

Other disease activity scores will be measured, including DAS28-ESR, which uses a different blood marker called erythrocyte sedimentation rate to assess inflammation.

SDAI and CDAI scores will also be calculated. These are simplified and clinical disease activity indexes that provide additional information about how active your arthritis is.

6 Blood sample collection for medication levels

Blood samples will be collected at specific times during the study to measure the concentration of RO7790121 in your bloodstream.

These measurements help determine how the medication is processed by your body.

7 Study completion

The study will continue until all scheduled assessments and treatments are completed.

Final evaluations will be performed to assess the overall effectiveness and safety of the treatment you received.

Any ongoing side effects or health concerns will be documented and addressed.

Who Can Join the Study?

You must have moderate to severe active rheumatoid arthritis, which means your joints are inflamed and painful. This is confirmed by having at least 6 swollen joints and at least 6 tender joints at the beginning of the study.
You must agree to use proper birth control methods during the study as required.
You must have been diagnosed with rheumatoid arthritis for at least 3 months and meet specific medical classification criteria established by rheumatology organizations.
You must have previously tried at least one TNF inhibitor or JAK inhibitor, which are types of medications used to treat rheumatoid arthritis, and either did not respond well to them, stopped responding to them over time, or could not tolerate them due to side effects.
You must be an adult aged 18 years or older.
Both men and women can participate in this study.

Who Cannot Join the Study?

The source data does not provide specific exclusion criteria, which are reasons why a patient cannot participate in the study
Without detailed information about which conditions or situations would prevent participation, a complete list of exclusion criteria cannot be provided
Generally, clinical trials may exclude patients based on certain health conditions, medications they are taking, or other factors, but these specific details are not available in the provided information

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
IRCCS Humanitas Research Hospital	Rozzano	Italy
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Reumed Sp. z o.o.	Lublin	Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.	Nowa Sol	Poland
Malopolskie Badania Kliniczne Sp. z o.o.	Cracow	Poland
MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH	Hamburg	Germany
Azienda Ospedaliera di Padova	Padua	Italy
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr	Herne	Germany
Reumatop Grzegorz Rozumek Karin Pistorius Sp. j.	Wroclaw	Poland
Staedtisches Klinikum Dresden	Dresden	Germany
Rheumazentrum Ratingen	Ratingen	Germany
Region Sjaelland	Holbæk	Denmark
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p.	Elblag	Poland
BIF-MED	Bytom	Poland
Nhujokxr Irlqjymc Gbofmmsbi Rzvukqxuwvnj I Rvdhdggbmclwe Il Pdyuq Dl Hvfi Miog Eollqnts Rzvsmpd	Warsaw	Poland
Hvcasv Hsvtrxyd	Herlev	Denmark
Atoajchjko Pqgkugpp Hzqtkcks Dp Mwmdubdnu	Marseille	France
Apjlqzc Uch Iyrhi Dv Rtpzpq Eypbyi	Reggio Emilia	Italy
Hkllwlfg Vamu dclnfuxy	Barcelona	Spain
Hoysoava Uiixhfhtyvsxt dr A Cebqft	A Coruna Galicia	Spain
Hqvdkkqc Uoegxhigazlcgw Snwifmuswr &wlujtv Hypcpha dn Hrotdyyhhaw	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	15.12.2025
Denmark	Recruiting	15.12.2025
France	Recruiting	15.12.2025
Germany	Recruiting	15.12.2025
Italy	Recruiting	15.12.2025
Poland	Recruiting	15.12.2025
Spain	Recruiting	15.12.2025

Trial locations

Investigated drugs:

Ro7790121

RO7790121 is an investigational medication being tested for the treatment of moderate to severe rheumatoid arthritis. It is being studied in patients who have not responded well to or cannot tolerate previous treatments known as TNF inhibitors or JAK inhibitors. This medication is still being researched and is not yet approved for general use.

Placebo is an inactive substance that looks like the real medication but contains no active treatment. It is used in this study to compare against the investigational medication to help determine if the medication being tested actually works.

Rheumatoid Arthritis – Rheumatoid arthritis is a long-term condition where the body’s immune system mistakenly attacks the joints, causing inflammation. It typically affects multiple joints on both sides of the body, most commonly the hands, wrists, and knees. The disease causes pain, swelling, and stiffness in the affected joints, which is often worse in the morning or after periods of rest. Over time, the ongoing inflammation can damage the joint tissues, including cartilage and bone. This damage can lead to reduced joint movement and changes in joint shape. The condition can also cause fatigue and may affect other parts of the body beyond the joints.

Trial ID:

2025-521034-28-00

Protocol code:

WA45846

Trial Phase:

Therapeutic exploratory (Phase II)

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A study testing RO7790121 for moderate to severe rheumatoid arthritis in patients who did not respond to or cannot tolerate TNF or JAK inhibitor treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?