3TR

Eligibility Criteria

Inclusion criteria

  1. 2010 ACR / EULAR classification criteria for a diagnosis of Rheumatoid Arthritis
  2. Patients with csDMARD failure and eligible for anti-TNF therapy according to EULAR recommendations: treatment for ≥3months with ≥ 1 csDMARDs
  3. Patients must have a DAS>5.1 and a minimum of 3 swollen joints – where the patient is undergoing a biopsy at visit 2, these should include the joint selected for biopsy and 2 other joints, as assessed at biopsy visit
  4. Selected joint for biopsy must be minimum grade 2 synovial thickening, as assessed at the biopsy visit
  5. 18 years of age or over
  6. Patients must be capable of giving informed consent and the consent must be obtained prior to any screening procedures

Exclusion criteria

  1. Women who are pregnant or breast-feeding
  2. 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.
  3. 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).
  4. Prior exposure to any biologic/targeted DMARDs for RA
  5. Treatment with any investigational agent ≤ 4 weeks prior to baseline or < 5 half-lives of the investigational drug (whichever is the longer)
  6. Any other contra-indication to the study medications as detailed in the applicable SmPc and active infection

Please refer to protocol for full inclusion/exclusion criteria.


3tr disclaimer

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking(JU) under grant agreement No 831434.
The JU receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.

The content of this website reflects only the author's view and JU is not responsible for any use that may be made of the information it contains.