Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the efficacy of switching to a different molecular target (from TNF to IL6) versus cycling to a second TNF inhibitor in patients with active RA, who have not adequately responded to a previous treatment with a first anti-TNF.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mario Negri Institute for Pharmacological Research
• Treatments: Adalimumab; Antibodies, Monoclonal; Certolizumab Pegol; Etanercept; Golimumab; Infliximab

Criteria

Inclusion Criteria:

• Age ≥18 years at the time of signing the informed consent form and either male or female.

• Diagnosis of RA according to the 1987 ACR classification criteria OR 2010 ACR/EULAR classification criteria at least 6 months prior to screening.

• Patients with persistent RA disease activity whilst being treated with an initial TNFi agent on a background MTX up to 20-25 mg/week for at least 12 weeks defined according to SIR and EULAR guidelines as: primary non-response: failing to improve DAS28 by ≥ 1.2 or failing to achieve DAS28 ≤ 3.2 within the first three to six months of starting the initial TNFi; secondary non-response: determined by physician decision with evidence of flare and deterioration in DAS28 of ≥ 1.2.

• Methotrexate (MTX) dose stable for 28 days prior to screening.

• Patients on NSAIDs and / or corticosteroids must remain on an unchanged regimen for at least 28 days prior to study drug administration.

• The patient must be able to comply with the study visit schedule and other protocol requirements.

• The patient understands the purpose of the study and is able and willing to sign the informed consent form, according to ICH/GCP.

• Signed written informed consent for biological analysis.

• Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Women of childbearing potential and male patients must be willing to practice acceptable methods of contraception during treatment and for 6 months (female patients) and 3 months (male patients) after discontinuation of treatment.

Exclusion Criteria:

• Patients who have previously received more than 1 TNFi drug OR any other biological therapy.

• Patients with inflammatory joint disease of different origin or any arthritis with onset prior to 16 years of age.

• Patients taking any disease-modifying antirheumatic drug (DMARDs) (e.g. all except methotrexate). Discontinuation must occur at least 28 days prior to study treatment start.

• History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug.

• Known hypersensitivity to any active substance or excipients of study drug.

• Pregnancy or breast feeding.