Abatacept for Rheumatoid arthritis

Inclusion criteria

• {"criterion_text":"- Adults (female and male) aged 18 or over.\n- Willing and capable of giving informed consent\n- 2010 ACR / EULAR classification criteria for a diagnosis of Rheumatoid Arthritis* (* The ACR/EULAR classification for a diagnosis of RA could have been at any time in the patient’s disease history; the score does not need to be 6 or more at screening.)\n- Symptom duration of <12 months\n- At least one swollen joint, which is amenable to synovial biopsy (minimum grade 2 synovial thickening, as assessed at the biopsy visit)\n- Moderate and severe Disease Activity (DAS28>3.2)\n- No prior DMARD therapies (conventional, targeted or biologic DMARDs)\n- Patient is judged by the supervising clinician to be a suitable candidate based upon medical history, physical examination, vital signs, and routine laboratory tests.\n- Willing and able to comply with scheduled visits, laboratory tests, and other study procedures."}

Exclusion criteria

• {"criterion_text":"- Patients unable to tolerate synovial biopsy or in whom this is contraindicated including patients on anti-coagulants (e.g. warfarin). Patients on short-acting direct oral anticoagulant agents can be considered when anti-coagulant can be temporarily stopped, in line with local guidelines for procedures with a low risk of bleeding, taking into account the individual thromboembolic risk. Oral anti-platelet agents are permitted.\n- Patients in whom there is no suitable joint for biopsy\n- Subject has a history or known presence of recurrent or chronic infection (eg, hepatitis B virus [HBV], hepatitis C virus [HCV], human immunodeficiency virus HIV]; recurrent urinary tract infections are allowed.\n- Subjects testing positive for acute or chronic hepatitis A, B, or C, unless they are indicative of prior hepatitis B vaccination or cured hepatitis A or B and accompanied by normal liver transaminase values.\n- Septic arthritis of a native joint within the last 12 months\n- Septic arthritis of a prosthetic joint within 12 months or indefinitely if the joint remains in situ\n- Latent TB infection unless they have completed adequate antibiotic prophylaxis\n- Receipt of live vaccine <3 months prior to first dose of study medication\n- Major surgery in 3 months prior to first dose of study medication\n- Presence of a transplanted organ (with the exception of a corneal transplant >3 months prior to screening).\n- Known recent substance abuse (drug or alcohol).\n- Patients currently recruited to other clinical trials or taking part in a CTIMP study in the previous 4 months.\n- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study. This should include assessment of risk factors for known clinically important risks associated with a study drug.\n- Patients with severe hepatic impairment (Child Pugh C classification).\n- Patients that are primary or secondary immunodeficiency (history of or currently active).\n- Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period.\n- Women who are pregnant or breast-feeding.\n- Women of child-bearing potential or males whose partners are women of child-bearing potential, unwilling to use an effective method of contraception (recommend double contraception) throughout the trial and beyond the end of trial treatment for the duration as defined in the relevant SmPC\n- Individuals who are unable to give informed consent for any reason (vulnerable groups).\n- Hypersensitivity to the active substance or to any of the excipients of abatacept or methotrexate, or any other contraindications to the study medications, as per the current SmPC\n- History of or current primary inflammatory joint disease or primary rheumatological autoimmune disease other than RA (if secondary to RA, then the patient is still eligible)\n- Prior exposure to any conventional/biologic/targeted DMARDs for RA\n- Treatment with any investigational agent ≤ 8 weeks prior to baseline or < 5 half-lives of the investigational drug (whichever is the longer)\n- Intra-articular or parenteral corticosteroids, or oral prednisolone more than 10mg/d or equivalent ≤ 4 weeks prior to screening visit\n- Patients with a serious underlying medical disorder (e.g., end stage renal disease).\n- Active infection"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of the study will be the delta CDAI at 16 weeks","definition_or_measurement_approach":""}

Secondary endpoints

• {"endpoint_text":"- Percentage of patients with DAS28<3.2 (LDA) at 16 weeks.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of patients deemed responders using American College of Rheumatology 50 (ACR50) measure at 16 weeks.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Percentage of patients with CDAI remission at 16 weeks","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in HAQ-DI at 16 weeks from baseline.","definition_or_measurement_approach":""}
• {"endpoint_text":"- Change in SF-36 at 16 weeks from baseline","definition_or_measurement_approach":""}

Methods

• Invitation letters / Summary Invitation Letter (document titles indicate use of invitation letters to potential participants).
• General Practitioner (GP) letters / GP Notification of Treatment Allocation (documents indicate GP notification/engagement).
• Site-based recruitment via participating hospital/clinic rheumatology departments (trial sites and Rheumatology department documents listed).

Netherlands

Earliest CTIS Part Ii Submission Date

17-01-2025

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

458

Number Of Sites

1

Number Of Participants

26

Spain

Earliest CTIS Part Ii Submission Date

23-01-2025

Latest Decision Or Authorization Date

24-04-2026

Processing Time Days

456

Number Of Sites

2

Number Of Participants

52

Portugal

Earliest CTIS Part Ii Submission Date

04-12-2024

Latest Decision Or Authorization Date

23-04-2026

Processing Time Days

505

Number Of Sites

1

Number Of Participants

26

Italy

Earliest CTIS Part Ii Submission Date

06-12-2024

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

500

Number Of Sites

4

Number Of Participants

52

Belgium

Earliest CTIS Part Ii Submission Date

20-12-2024

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

486

Number Of Sites

1

Number Of Participants

26

Primary sponsor

Full Name

Queen Mary University Of London

Organisation Type

Educational Institution

Country Of Registered Address

United Kingdom

Third parties

• {"country":"","full_name":"The Innovative Medicines Initiative 2 Joint Undertaking IMI2 JU","duties_or_roles":"Monetary support","organisation_type":""}