Last updated on January 2019

Prediction of Response to Certolizumab Pegol Treatment by Functional MRI of the Brain

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Rheumatoid Arthritis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Understands and voluntarily signs an informed consent form
  • Male or female, aged 18 years at time of consent
  • Must be able to adhere to the study visit schedule and other protocol requirements
  • Must satisfy the 2010 ACR/EULAR classification criteria for rheumatoid arthritis plus a disease duration of at least 6 months.
  • Must have active RA with a DAS28 3.2
  • Must be RF and/or ACPA positive
  • 3 swollen and/or tender joints of the hands
  • At screening- visit patients should have been treated without alterations of therapy for at least three months with DMARDS (i.e. Methotrexate) with or without concomitant use of steroids).
  • Glucocorticoids treatment up to 10mg prednisolone per day will be allowed at study entry.

. Exclusion Criteria:

  • Individuals not able to understand and follow study protocol and not able to voluntarily sign informed consent
  • Individuals not willing to follow study protocol and sign informed consent
  • Individuals with claustrophobia, tattoos containing metal, magnetic endoprostheses, surgery on bone in between a time interval < 3 months.
  • Patients treated before with any biological or small molecule or medication under investigation for the treatment of RA.
  • Patients with serious or chronic infections within the previous 3 months
  • Opportunistic infections within the 6 months before screening
  • Cancer within the 5 years before screening (with the exception of treated and cured squamous or basal cell carcinoma of the skin)
  • History of severe congestive heart failure
  • Current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal (a.e.diverticulitis), endocrine, pulmonary, cardiac, neurologic or cerebral disease
  • Transplanted organ (with the exception of corneal transplantation done more than 3 months before screening)
  • Evidence of active tuberculosis

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

Volunteer Sign-up

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.