Study Comparing Abatacept and Tocilizumab for Adults with Rheumatoid Arthritis Not Responding to Previous Treatments

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What is this study about?

This clinical trial is focused on studying the effectiveness of two medications, abatacept and tocilizumab, for treating rheumatoid arthritis. Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects joints, causing pain and swelling. The study involves patients who have not responded adequately to one or two previous targeted treatments. The medications being tested are administered through injections under the skin.

The purpose of the study is to compare the effectiveness of tocilizumab and abatacept in patients who have not had sufficient improvement with previous treatments. Participants will receive either of the medications for a period of up to 12 months. During this time, their condition will be monitored to assess changes in disease activity and overall health. The study will also track any side effects experienced by participants.

Throughout the study, participants will have regular check-ups to evaluate their response to the treatment. These evaluations will include assessments of joint tenderness and swelling, as well as overall health and quality of life. The study aims to provide valuable information on which medication may be more effective for patients with rheumatoid arthritis who have not responded well to other treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, diagnosis of rheumatoid arthritis, and previous treatment responses.

The assessment ensures that the patient has an inadequate response to one or two targeted treatments, as defined by specific disease activity scores.

2 randomization and treatment assignment

Patients are randomly assigned to receive either abatacept or tocilizumab. Both medications are administered via subcutaneous injection.

The specific medication and dosage are determined by the study protocol: ORENCIA (abatacept) 125 mg or RoActemra (tocilizumab) 162 mg, both provided in pre-filled syringes.

3 treatment administration

The assigned medication is administered according to the study schedule. The frequency and duration of administration are specified by the trial protocol.

Patients receive their medication through subcutaneous injections, which are typically self-administered or administered by a healthcare professional.

4 follow-up assessments

Regular follow-up assessments are conducted at 3, 6, and 12 months to monitor treatment response and side effects.

These assessments include evaluations of disease activity, quality of life, and any side effects experienced.

5 primary outcome evaluation

The primary outcome is evaluated at 6 months, focusing on changes in the Clinical Disease Activity Index (CDAI).

This index measures disease activity based on joint counts and patient and evaluator assessments.

6 secondary outcome evaluation

Secondary outcomes are assessed at 3, 6, and 12 months, including various disease activity scores and quality of life measures.

Additional evaluations include the proportion of patients achieving specific therapeutic responses and the occurrence of side effects.

7 completion of trial participation

Upon completion of the 12-month period, patients conclude their participation in the trial.

Final assessments are conducted to gather comprehensive data on treatment efficacy and safety.

Who Can Join the Study?

Must be an adult, meaning you are over 18 years old.
Have a condition called rheumatoid arthritis as defined by specific criteria from medical organizations (ACR/EULAR 2010).
Have not responded well to one or two specific treatments, which means your disease activity is still moderate to high after at least 3 months of treatment. This is measured by scores called DAS28-ESR greater than 3.2 and CDAI greater than 10.
Be a member of the French National Health Insurance Fund.
Have signed a form that shows you understand the study and agree to participate.
If you are a woman who can have children, you must use effective birth control during the study and continue using it for 14 weeks after the last treatment.

Who Cannot Join the Study?

Patients who do not have rheumatoid arthritis. Rheumatoid arthritis is a condition where the body’s defense system attacks the joints, causing pain and swelling.
Patients who have not tried at least one or two specific treatments for their rheumatoid arthritis.
Patients who are not adults. This means individuals under the age of 18 cannot participate.
Patients who are not able to receive injections under the skin, as the study involves medications given this way.
Patients who are part of a vulnerable group, which means they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
CHU Grenoble Alpes	La Tronche	France

Other Sites

Site Name	City	Country
Hôpital Avicenne	Bobigny	France
Clinique De L’infirmerie Protestante De Lyon	Caluire Et Cuire	France
Centre Hospitalier Jean Rougier	Cahors	France
Centre Hospitalier De Valenciennes	Valenciennes	France
Assistance Publique Hopitaux De Paris	Paris	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
CHU Gabriel-Montpied	Clermont Ferrand	France
Groupement Des Hopitaux De L’Institut Catholique De Lille	lomme	France
Cemv dy Tsqjqu Hogracs Tcuzjsrsz	Chambray Les Tours	France
Hajpzww Nbxl &xpvmbu Svsu df Pvjnchft	Cergy Pontoise	France
Csk du Rcslt &hrtxcl Hzfjfvf du Bepd Gppvbujat	Rouen	France
Csjzdh Hfceereucjt dg Bkhfdycg slp Mqa	Boulogne sur Mer	France
Aektieyinv Ppmpuoas Hqvldyha Dw Pqctr	Paris	France
Abiubctugq Pdavwvpl Hfpfxbdm Dn Psxdq	Paris	France
Cbwf De Nzwak	Vandoeuvre Les Nancy	France
Upxltixefl Hxqdlzaic Pdkvc Stzkycokptr Ciwpeft Fciy	Paris	France
Inaxqmor du Cmqghwdkzjlm Hbbcdrnmunk Uvuyyixfkyzkf dh Sffaw Ejklmsn (qlpghjl	Saint Priest En Jarez	France
Hwjtdgpt Uonoweejvkmpqf Szepcffjle &zixsuz Hgzclpl de Hiaorfijgyu	STRASBOURG, Alsace	France
Chh Koukqby Bkndvbb	Le Kremlin-Bicetre	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	02.10.2017

Trial locations

Investigated drugs:

Abatacept is a medication used to treat rheumatoid arthritis. It works by interfering with the immune system’s activity, which helps reduce inflammation and slow down the progression of the disease. In this trial, abatacept is given through an injection under the skin to see how effective it is for patients who have not responded well to other treatments.

Tocilizumab is another medication used for rheumatoid arthritis. It targets specific proteins in the body that cause inflammation, helping to relieve symptoms and prevent joint damage. In this study, tocilizumab is also administered as an injection under the skin, and its effectiveness is being compared to that of abatacept in patients who have not had success with previous treatments.

Rheumatoid Arthritis – Rheumatoid arthritis is a chronic inflammatory disorder that primarily affects the joints. It typically causes pain, swelling, and stiffness in the joints, often starting in the small joints of the hands and feet. Over time, it can lead to joint damage and deformities. The disease progresses through periods of flares and remissions, where symptoms can worsen or improve. It can also affect other parts of the body, including the skin, eyes, lungs, and blood vessels. The exact cause is unknown, but it involves the immune system attacking the body’s own tissues.

Trial ID:

2024-515600-39-00

Protocol code:

RC-P0055

NCT ID:

NCT03227419

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study Comparing Abatacept and Tocilizumab for Adults with Rheumatoid Arthritis Not Responding to Previous Treatments

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?